Prevalence and Risk Factors of Constipation Symptoms among Patients Undergoing Colonoscopy: A Single-Center Cross-Sectional Study.

INTRODUCTION: Constipation is one of the most common gastrointestinal symptoms. It may compromise quality of life and social functioning and result in increased healthcare use and costs. We aimed to evaluate the prevalence and risk factors of constipation symptoms, as well as those of refractory constipation symptoms among patients who underwent colonoscopy. METHODS: Over 4.5 years, patients who underwent colonoscopy and completed questionnaires were analyzed. Patients' symptoms were evaluated using the Gastrointestinal Symptoms Rating Scale. RESULTS: Among 8,621 eligible patients, the prevalence of constipation symptoms was 33.3%. Multivariate analysis revealed female sex (odds ratio [OR] 1.7, p < 0.001), older age (OR 1.3, p < 0.001), cerebral stroke with paralysis (OR 1.7, p = 0.009), chronic renal failure (OR 2.6, p < 0.001), ischemic heart disease (OR 1.3, p = 0.008), diabetes (OR 1.4, p < 0.001), chronic obstructive pulmonary disease (OR 1.5, p = 0.002), benzodiazepine use (OR 1.7, p < 0.001), antiparkinsonian medications use (OR 1.9, p = 0.030), and opioid use (OR 2.1, p = 0.002) as independent risk factors for constipation symptoms. The number of patients taking any medication for constipation was 1,134 (13.2%); however, refractory symptoms of constipation were still present in 61.4% of these patients. Diabetes (OR 1.5, p = 0.028) and irritable bowel syndrome (OR 3.1, p < 0.001) were identified as predictors for refractory constipation symptoms. CONCLUSIONS: Constipation occurred in one-third of patients, and more than half of patients still exhibited refractory symptoms of constipation despite taking laxatives. Multiple medications and concurrent diseases seem to be associated with constipation symptoms.

Bacillus Subtilis (BG01-4TM) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial.

BACKGROUND: Functional gastrointestinal disorders (FGIDs) are common, difficult-to-manage conditions. Probiotics are emerging as a dietary component that influence gastrointestinal (GI) health. We conducted a double-blinded randomised controlled trial of a proprietary strain of deactivated Bacillus subtilis (BG01-4™) high in branched-chain fatty acids (BCFA) to treat self-reported FGID. METHODS: Participants (n = 67) completed a four-week intervention of BG01-4™ (n = 34) or placebo (n = 33). The Gastrointestinal Symptom Rating Scale (GSRS) served as the outcome measure, collected prior to, at two weeks, and at four weeks after completion of the intervention. RESULTS: At four weeks, one of three primary outcomes, constipation in the experimental group, was improved by 33% compared to placebo (15%); both other primary outcomes, Total GSRS and diarrhoea, were significantly improved in both the experimental and placebo groups (32%/26% and 20%/22%, respectively). The pre-planned secondary outcome, indigestion, was improved at four weeks (32%) but compared to the placebo (21%) was not significant (p = 0.079). Exploratory analysis, however, revealed that clusters for constipation (18% improvement, p < 0.001), indigestion (11% improvement, p = 0.04), and dyspepsia (10% improvement, p = 0.04) were significantly improved in the intervention group compared to the placebo. CONCLUSIONS: These initial findings suggest that in people with self-reported FGID, BG01-4™ improves specific symptoms of constipation and related GI dysfunction. Longer-term confirmatory studies for this intervention are warranted. TRIAL REGISTRATION: This study was registered prospectively (25 October 2021) at the Australian New Zealand Clinical Trials Registry (ACTRN12621001441808p).

Probiotic containing Lactobacillus reuteri DSM 17648 as an adjunct treatment for Helicobacter pylori infection: A randomized, double-blind, placebo-controlled trial.

BACKGROUND: Despite multiple therapy regimens, the decline in the Helicobacter pylori eradication rate poses a significant challenge to the medical community. Adding Lactobacillus reuteri probiotic as an adjunct treatment has shown some promising results. This study aims to investigate the efficacy of Lactobacillus reuteri DSM 17648 in H. pylori eradication and its effect in ameliorating gastrointestinal symptoms and adverse treatment effects. MATERIALS AND METHODS: This randomized, double-blinded, placebo-controlled trial involved treatment-naïve H. pylori-positive patients. Ninety patients received standard triple therapy for 2 weeks before receiving either a probiotic or placebo for 4 weeks. The posttreatment eradication rate was assessed via a 14 C urea breath test in Week 8. The Gastrointestinal Symptom Rating Scale (GSRS) questionnaire and an interview on treatment adverse effects were conducted during this study. RESULTS: The eradication rate was higher in the probiotic group than in the placebo group, with a 22.2% difference in the intention-to-treat analysis (91.1% vs. 68.9%; p = 0.007) and 24.3% difference in the per-protocol analysis (93.2% vs. 68.9%; p = 0.007). The probiotic group showed significant pre- to post-treatment reductions in indigestion, constipation, abdominal pain, and total GSRS scores. The probiotic group showed significantly greater reductions in GSRS scores than the placebo group: indigestion (4.34 ± 5.00 vs. 1.78 ± 5.64; p = 0.026), abdominal pain (2.64 ± 2.88 vs. 0.89 ± 3.11; p = 0.007), constipation (2.34 ± 3.91 vs. 0.64 ± 2.92; p = 0.023), and total score (12.41 ± 12.19 vs. 4.24 ± 13.72; p = 0.004). The probiotic group reported significantly fewer adverse headache (0% vs. 15.6%; p = 0.012) and abdominal pain (0% vs. 13.3%; p = 0.026) effects. CONCLUSIONS: There was a significant increase in H. pylori eradication rate and attenuation of symptoms and adverse treatment effects when L. reuteri was given as an adjunct treatment.

CLINICAL SIGNS AND QUALITY OF LIFE ANALYSIS IN THE PATIENTS WITH HYPOTHYREOSIS AND CHRONIC PANCREATITIS.

OBJECTIVE: Aim: To analyze the clinical condition and evaluate the quality of life of patients with a comorbid course of Ht and CP and patients with isolated CP based on the results of testing according to the GSRS and SF-36 questionnaires. PATIENTS AND METHODS: Materials and methods: Were examined 62 patients with comorbid course of Ht and CP. The comparison group consisted of 48 people with isolated CP, the control group consisted of 30 healthy people, comparable in age and sex. The average age of all patients was (51.4±26.7) years. Two questionnaires were used in the study: the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire was used to assess the severity of gastroenterological symptoms and QoL, and the general SF-36 questionnaire was used to assess the clinic and health status. RESULTS: Results: Analyzing the data of the GSRS questionnaire, it was found that in patients with a comorbid course of Ht and CP, reflux, pain and dyspepsia syndromes took the leading place in the clinic of the disease (p>0.05). They should be considered as the main factor in reducing the quality of life in patients with a comorbid course of Ht and CP. According to the GSRS questionnaire, the comorbidity of Ht and CP caused a complication of the clinical condition compared to patients with isolated CP of a gastroenterological patient: according to the scale of gastric reflux - by 48.57%, according to the scale of dyspepsia - by 35.84%, diarrhea - by 26.94%, constipation - by 19.93%, abdominal pain - by 40.81% (p<0.05). As a result of the study, a significantly lower level of quality of life was established in patients with a comorbid course of Ht and CP. CONCLUSION: Conclusions: It has been proven that the quality of life of patients with a comorbid course of Ht and CP was significantly lower compared to that of isolated CP (the total difference between groups on all scales of the GSRS questionnaire was 33.59% (p<0.05)). According to the SF-36 questionnaire, the overall quality of life of patients with a comorbid course of Ht and CP, compared to the group of patients with isolated CP, was reduced by 34.9% and 20.9% on the scales of physical and psychological health (р<0, 05).

An Exploratory Study Investigating the Prevalence of Gastrointestinal Symptoms in Collegiate Division I American Football Athletes.

Gastrointestinal (GI) symptoms may limit performance, but their prevalence and impact among team sports athletes is not well-documented. The objective of this study was to examine the prevalence of GI symptoms in a small sample of collegiate DI American football athletes, using a survey including the Gastrointestinal Symptoms Ratings Scale (GSRS). Forty-six athletes responded to the survey and reported scores for the 15-question GSRS with additional questions about dietary habits and supplement use. A total of 44 athletes were included in the study (45% of the current roster, age: 20.7 ± 1.7 years, 50% Afro-American or black, 39% skill position, 18% NSAIDs use, and 41% reporting protein supplement use); approximately half of the athletes (52%) reported experiencing GI complaints during exercise. Two-thirds of the athletes (61%) reported at least one or more GI symptoms in general, and 50% reported at least four moderate complaints. Seven athletes (16%) reported ≥2 severe GI symptoms with 5-13 moderate complaints. The most reported symptom was stomach pain (39%, n = 17), followed by hunger pain (36%, n = 16). Athletes reporting the use of protein supplements reported a higher GSRS score (22.0 and interquartile range (IQR) 17.0-31.8) vs. athletes not reporting protein use (15.0 and IQR 15.0-19.3), p = 0.001. Most athletes surveyed reported experiencing GI symptoms. A small group of these athletes reported multiple, varied, and severe symptoms that were associated with self-reported protein supplement use. In conclusion, the number of complaints varied among athletes, confirming the value of integrating the GSRS for screening purposes, and the expected need for individual dietary treatment approaches.

[Electroacupuncture for acute exacerbation of chronic obstructive pulmonary disease complicated with gastrointestinal dysfunction: a randomized controlled trial].

OBJECTIVE: To observe the clinical effect of electroacupuncture (EA) for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated with gastrointestinal dysfunction. METHODS: A total of 100 patients with AECOPD complicated with gastrointestinal dysfunction were randomly divided into an EA group (50 cases, 2 cases dropped off, 1 case excluded) and a medication group (50 cases). Both groups were treated with symptomatic and supportive treatment such as low flow oxygen, nebulized inhalation of short-acting ß2 agonist (SABA) or short-acting muscarinic antagonist (SAMA) combined with inhaled corticosteroid (ICS). The EA group was treated with EA at Zusanli (ST 36), Yinlingquan (SP 9), Zhongwan (CV 12), Shuifen (CV 9), Tianshu (ST 25), Chize (LU 5) and Lieque (LU 7), with discontinuous wave, 2 Hz in frequency, 30 min each time, once a day. In the medication group, oral mosapride citrate tablets were given, 3 times a day, 5 mg each time. Both groups were treated for 5 d. Before and after treatment, the gastrointestinal symptom rating scale (GSRS) score was observe, serum procalcitonin (PCT), C-reactive protein (CRP), and plasma oxygenation index (PaO2/FiO2) were detected, and patient satisfaction degree was evaluated in the two groups. RESULTS: Compared with before treatment, except for diarrhea dimension in the medication group, the total scores and each dimension scores of GSRS were decreased (P<0.05), serum PCT and CRP were decreased (P<0.05), plasma PaO2/FiO2 was increased (P<0.05) in the two groups after treatment. After treatment, in the EA group, the total score and abdominal pain, dyspepsia, constipation and diarrhea scores of GSRS were lower than those in the medication group (P<0.05), meanwhile serum PCT and CRP were lower and plasma PaO2/FiO2 was higher than those in the medication group (P<0.05). The improvement of gastrointestinal symptoms, life quality and overall satisfaction degree in the EA group were superior to those in the medication group (P<0.05). CONCLUSION: EA could improve the symptoms of patients with AECOPD complicated with gastrointestinal dysfunction, reduce inflammatory response, improve oxygenation and patient satisfaction degree.

Presence of gastrointestinal symptoms in IgA nephropathy: a cross-sectional study.

BACKGROUND: Gastrointestinal (GI) symptoms are common in end-stage kidney disease. Mounting evidence indicates that the intestine plays an important role in the pathogenesis of IgA nephropathy (IgAN). However, no studies have addressed the obvious question; do IgAN patients suffer from GI symptoms? METHODS: Presence of GI symptoms and health-related quality of life were evaluated using the validated Gastrointestinal Symptom Rating Scale (GSRS) and Psychological General Well-Being (PGWB) questionnaires in 104 patients with kidney biopsy-verified IgAN and in 147 healthy controls. A person was regarded to experience 'increased GI symptoms' if the GSRS score exceeded plus 1 standard deviation of the mean of the corresponding score in the healthy controls. RESULTS: According to the GSRS total score, the IgAN patients had more GI symptoms than the healthy controls (2.0 vs. 1.7, p < 0.001). Female IgAN patients had higher GSRS total score than male patients (2.2 vs. 1.7, p = 0.001). More IgAN patients with preserved kidney function (eGFR > 60ml/min/1.73m2) suffered from increased symptoms of diarrhoea (76 vs. 25%, p = 0.028), constipation (81 vs. 19%, p = 0.046) and reflux (85 vs. 15%, p = 0.004) than did IgAN patients with reduced kidney function (eGFR < 60ml/min/1.73m2). CONCLUSIONS: IgAN patients and especially female IgAN patients experienced more GI symptoms than healthy controls. More prevalent GI symptoms were already observed before kidney function was clearly reduced. Systematic enquiry of GI symptoms might increase the standard of care among IgAN patients. Moreover, GI symptoms may provide clues for future studies that examine the pathophysiology of IgAN.

Two Gold Kiwifruit Daily for Effective Treatment of Constipation in Adults-A Randomized Clinical Trial.

Chronic constipation is highly prevalent worldwide and may be managed with two green or three gold kiwifruit daily. It is unknown whether a smaller standard serve of gold kiwifruit (two daily) is as effective in constipation management. The study aimed to improve chronic constipation with two gold kiwifruit and psyllium in lieu of a placebo daily over four weeks. Adult participants (18-65 years) with functional constipation (FC, n = 11), constipation-predominant irritable bowel syndrome (IBS-C, n = 13), and healthy controls (n = 32) were block-randomized to the treatment order: gold kiwifruit (2/day) or psyllium (fiber-matched, 7.5 g/day) for four weeks, followed by four weeks washout before crossover. Outcomes included alterations of Gastrointestinal Symptom Rating Scale (GSRS) domains and weekly complete spontaneous bowel movements (CSBM) as part of a larger study. Both interventions reduced GSRS constipation domain scores in all subjects compared to baseline values (p = 0.004). All participants reported significantly more weekly CSBM (p = 0.014). Two gold kiwifruit decreased straining (p = 0.021). Two gold kiwifruit daily are as effective as fiber-matched psyllium in treating constipation in adults and should be considered as a treatment option.

Understanding and modifying Fabry disease: Rationale and design of a pivotal Phase 3 study and results from a patient-reported outcome validation study.

The use of available treatments for Fabry disease (FD) (including enzyme replacement therapy [ERT]) may be restricted by their limited symptom improvement and mode of administration. Lucerastat is currently being investigated in the MODIFY study as oral substrate reduction therapy for the treatment of FD. By reducing the net globotriaosylceramide (Gb3) load in tissues, lucerastat has disease-modifying potential to improve symptoms and delay disease progression. MODIFY is a multicenter, double-blind, randomized, placebo-controlled, parallel-group Phase 3 study (ClinicalTrial.gov: NCT03425539); here we present the rationale and design of this study. Eligible adults with a genetically confirmed diagnosis of FD and FD-specific neuropathic pain entered screening. Patients were randomized (2:1) to receive either oral lucerastat twice daily or placebo for 6 months; treatment allocation was stratified according to sex and ERT treatment status. The main objectives of MODIFY are to assess the effects of lucerastat on neuropathic pain, gastrointestinal (GI) symptoms, FD biomarkers, and determine its safety and tolerability. Neuropathic pain and GI symptoms are key features of FD that have a significant impact on quality of life. Despite various tools available to assess pain and GI symptoms, there are currently limited tools available to assess neuropathic and GI symptoms in FD, validated according to health authority guidelines. Based on FDA recommendations, we undertook a patient-reported outcome (PRO) validation study, using a novel eDiary-based PRO tool to assess the validity of evaluating neuropathic pain as a primary efficacy endpoint in MODIFY. Results from the PRO validation study are included. To date, MODIFY is the largest Phase 3 clinical study conducted in patients with FD. Enrollment to MODIFY is now complete, with 118 patients randomized. Results will be presented in a separate publication. Long-term effects of lucerastat are being assessed in the ongoing open-label extension study (NCT03737214).

Efficacy and acceptability of pomegranate effervescent granules in patients suffering from acid peptic disorders.

CONTEXT: Acid peptic disorders. AIMS: This study aimed to assess the efficacy and acceptability of pomegranate effervescent granules (PEGs) in dyspeptic patients. SETTINGS AND DESIGN: It was a single-arm, open-labeled prospective multicentric clinical study, done at 3 centers: Vishwanand Kendra, Pune; Bharati Ayurved Hospital, Bharati Vidyapeeth, Pune, and M. A. Podar Medical Ayurved Hospital, Mumbai. The co-ordinating site was Interactive Research School for Health Affairs, Bharati Vidyapeeth, Pune. MATERIALS AND METHODS: The granules, prepared from peel extract of pomegranate, were made available in sachets of 2.5 g with dose of, 1 sachet dissolved in 200 ml (1 cup) of water, twice a day after meals for 28 days. Gastrointestinal Symptom Rating Scale (GSRS) scores to assess symptoms of acid peptic disorders at day 0, 15, and 29 along with the taste of formulation were the main study outcomes. STATISTICAL ANALYSIS USED: Parametric data, presented as mean ± standard deviation, were analyzed using paired t-test, while nonparametric data presented as median (range) was analyzed using Wilcoxon rank-sum test. Categorical data were analyzed using Chi-square test. RESULTS: The median GSRS score reduced from 14 on day 0-10 and then 5 on day 15 and day 29, respectively, with statistical significance. The formulation was found to taste good by ~80% of patients, while ~20% reported it to be palatable and none found it to be bad in taste. CONCLUSION: PEGs proved to be palatable, patient-friendly, safe, and efficacious in resolving symptoms of dyspepsia in acid peptic disorders. CTRI Registration: The trial was registered retrospectively in the Clinical Registry of India [CTRI/2017/07/008999].

Effects of colorectal endoscopic submucosal dissection on postoperative abdominal symptoms: a prospective observational study.

BACKGROUND: Endoscopic submucosal dissection (ESD) is an effective procedure to resect large superficial gastrointestinal neoplasms. In gastric ESD, several studies showed the relationship between postoperative abdominal symptoms and endoscopic treatment. However, the influence of colorectal ESD on abdominal symptoms after treatment is still unknown. To the best of our knowledge, this is the first prospective multicenter study performed to investigate the impact of colorectal ESD on postoperative abdominal symptoms. This study aimed to clarify the association between change of abdominal symptoms and ESD. METHODS: This study was a prospective multicenter observational trial that enrolled 141 out of 171 patients who underwent colorectal ESD and answered the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire from March 2015 to August 2019. We evaluated abdominal symptoms in the patients using the GSRS questionnaire before ESD and a few weeks after ESD. RESULTS: Comparing the GSRS before and after ESD, overall scores changed from 1.58 ± 0.58 to 1.48 ± 0.48, and the five subscales (reflux syndrome, abdominal pain, indigestion syndrome, diarrhea syndrome, and constipation syndrome) were slightly improved. Overall scores, indigestion syndrome, and constipation syndrome were statistically significantly different before and after ESD (P < 0.05). CONCLUSIONS: In GSRS, a score of ≥ 3 is often treated as a clinically significant symptom. Therefore, our findings indicated that there was no clinically significant difference. For this reason, colorectal ESD does not affect postoperative abdominal symptoms and is considered a minimally invasive treatment. The analysis of the impact of colon ESD on gastrointestinal symptoms UMIN000016914.

Impact of Different Helicobacter pylori Eradication Therapies on Gastrointestinal Symptoms.

Background and Objectives: Helicobacter pylori (H. pylori) infection impairs quality of life. However, whether eradication therapy ameliorates gastrointestinal symptoms remains questionable. The main objective of this study was to evaluate the influence of H. pylori eradication therapy on gastrointestinal symptoms. Materials and Methods: A total of 140 patients, 59 women and 81 men, with a mean age of 61 and suffering from H. pylori infection in the University Hospital of Split, Croatia, were enrolled in the study. Patients were randomly assigned to either concomitant or hybrid therapies. The Gastrointestinal Symptom Rating Scale (GSRS) questionnaire was completed by patients prior to and after the eradication therapy. Results: In both groups, the total GSRS score improved significantly after therapy. In the concomitant group, the abdominal pain score, reflux symptoms score and indigestion score decreased significantly after therapy. In the group with hybrid therapy, all five groups of symptoms (abdominal pain, reflux symptoms, indigestion, diarrhea and constipation) significantly decreased after therapy. Patients with adverse events had significantly higher total GSRS scores after eradication therapy. Conclusions: H. pylori eradication therapy could alleviate gastrointestinal symptoms regardless of the treatment used, but the favorable effect seemed to be more pronounced after hybrid therapy.

Evaluation of fecal calprotectin as a marker of gastrointestinal inflammation in rosacea: A case-control study.

A higher incidence of gastrointestinal diseases has been well established in patients with rosacea. However, no screening tool has been introduced for gastrointestinal disease development in rosacea. Fecal calprotectin (FC) is a calcium-binding protein, mainly derived from polymorpho-nuclear cells, such as neutrophils. It has been established as a marker of gastrointestinal inflammation. The aim of the present study was to evaluate FC levels in patients with rosacea without any gastrointestinal diseases. A prospective, case-control study was planned to investigate the relationship between rosacea and gastrointestinal involvement by evaluating FC levels and the Gastrointestinal Symptom Rating Scale (GSRS). A total of 47 patients with rosacea and 39 healthy control subjects were included in the study. The FC levels were statistically significantly higher in rosacea group than in the control group (65.96 ± 58.86 ng/mL vs 31.99 ± 20.12 ng/mL, P = .026, respectively). A statistically significant difference was also observed in GSRS values between the patient and the control groups (30.26 ± 12.48 vs 22.62 ± 7.64, P = .001, respectively). A positive correlation was noted between FC levels and the values of GSRS in the study group (r: 0.354; P = .001) and in the rosacea group (r = 0.392, P = .006). The measurement of FC may be useful in the early detection of gastrointestinal system diseases that may accompany rosacea and may provide a pathway to develop treatment strategies targeting both skin and intestinal mucosa.

High Prevalence and Gender-Related Differences of Gastrointestinal Manifestations in a Cohort of DM1 Patients: A Perspective, Cross-Sectional Study.

Myotonic dystrophy type 1 (DM1, MIM #160900), the most common muscular dystrophy among adults, is a multisystem disorder, which affects, besides the skeletal muscle, several other tissues and/or organs, including the gastrointestinal apparatus, with manifestations that frequently affect the quality of life of DM1 patients. So far, only few, mainly retrospective studies evaluated this specific topic in DM1, so we performed a perspective study, enrolling 61 DM1 patients who underwent an extensive diagnostic protocol, including administration of the Gastrointestinal Symptom Rating Scale (GSRS), a validated patient-reported questionnaire about GI symptoms, laboratory tests, liver US scan, and an intestinal permeability assay, in order to characterize frequency and assess correlations regarding specific gastrointestinal manifestations with demographic or other DM1-related features. Our results in our DM1 cohort confirm the high frequency of various gastrointestinal manifestations, with the most frequent being constipation (45.9%). γGT levels were pathologically increased in 65% of DM1 patients and GPT in 29.82%; liver ultrasound studies showed steatosis in 34.4% of patients. Significantly, 91.22% of DM1 patients showed signs of altered intestinal permeability at the specific assay. We documented a gender-related prevalence and severity of gastrointestinal manifestations in DM1 females compared to DM1 males, while males showed higher serum GPT and γGT levels than females. Correlation studies documented a direct correlation between severity of muscle weakness estimated by MIRS score and γGT and alkaline phosphatase levels, suggesting their potential use as biomarkers of muscle disease severity in DM1.

Impact of symptom severity in patients with diarrhoea-predominant irritable bowel syndrome (IBS-D): results from two separate surveys of HCPs and patients with IBS-D.

BACKGROUND: Management of diarrhoea-predominant irritable bowel syndrome (IBS-D) is generally based on patient-reported symptoms; however, limited information on symptom severity exists. The objective of the study was to assess the impact of IBS-D severity on patient burden and patient and healthcare professional attitudes towards IBS. METHODS: We conducted two web-based surveys of healthcare professionals and patients from Australia, Canada and Europe. We analysed patient characteristics and attitudes by IBS-D severity, which was assessed retrospectively using a composite of four variables: worst abdominal pain, IBS symptom frequency, Bristol Stool Form Scale and quality of life. RESULTS: Of 679 healthcare professional respondents, one-third routinely classified patients by severity. The patient survey was completed by 513 patients with mild (26%), moderate (33%) and severe (41%) IBS-D, classified using the composite scale. Age, sex and treatment satisfaction did not change with severity; however, 19% of patients classified with severe IBS-D agreed with the statement: 'When my IBS is bad, I wish I was dead' versus 4 and 7% of patients with mild and moderate IBS-D, respectively (p < 0.05). Significantly more patients classified with severe IBS-D reported medication use versus mild IBS-D. CONCLUSION: Compared with milder symptoms, severe IBS-D was associated with increased medication use and a negative perspective of IBS-D. This highlights the need for a validated severity scale to inform treatment decisions.

A Dose-Escalation Study Demonstrates the Safety and Tolerability of Cellobiose in Healthy Subjects.

The disaccharide and innovative ingredient cellobiose, consisting of two ß-glucose molecules linked by a ß(1→4) bond is the main component of cellulose. Cellobiose can be used within a wide variety of foodstuffs and functional foods as a low-caloric bulking agent or as a substitute for lactose. For purposes of industrial large-scale production, cellobiose is produced by an enzymatic reaction in which sucrose and glucose are converted to cellobiose and fructose. The goal of this single-arm, dose-escalation study was to evaluate the safety and tolerability of cellobiose and to determine the maximum tolerated dose of cellobiose in healthy subjects. Following a baseline period, consecutive cohorts of six subjects each consumed either single doses of 10, 15, 20 and 25 g, while 12 subjects each received multiple doses of 15 g or 20 g cellobiose (twice daily, 14 days). The main recorded parameters were stool consistency, gastrointestinal well-being (Gastrointestinal Symptom Rating Scale) and adverse events. In each highest single/multiple dosage group, some sensitive subjects experienced flatulence, borborygmus and/or transient diarrhoea. A 100% global tolerability rating makes 20 g cellobiose a tolerable dose for single use. For repeated consumption, we propose up to 15 g cellobiose twice daily (92.6% global tolerability rating). Cellobiose is a promising new ingredient with excellent tolerability.

The effect of 'Zesy002' kiwifruit (Actinidia chinensis var. chinensis) on gut health function: a randomised cross-over clinical trial.

Functional gastrointestinal disorders including constipation affect up to 14 % of the world's population. Treatment is difficult and challenging resulting in a need for alternative safe and effective therapies. The present study investigated whether daily consumption of three gold-fleshed kiwifruit could alleviate constipation and improve gastrointestinal discomfort in mildly constipated individuals with and without pain. A total of thirty-two participants were enrolled in a 16-week randomised, single-blind, crossover study. Participants received either three 'Zesy002' kiwifruit or 14·75 g Metamucil® (5 g dietary fibre/d (a positive control)) for 4 weeks each with a 4-week washout between treatments. A 2-week washout period was included at the beginning and end of the study. Daily bowel habit diaries were kept throughout the study. The primary outcome measure was differences in the number of complete spontaneous bowel movements (CSBM). Secondary outcome measures were bowel movement frequency and stool form as well as digestive symptoms and comfort. The number of CSBM per week was significantly greater during daily consumption of three kiwifruit compared with the baseline (6·3 v. 3·3; P < 0·05) and the Metamucil® treatment (6·3 v. 4·5; P < 0·05). Stool consistency was also improved, with kiwifruit producing softer stools and less straining (P < 0·05). Gastrointestinal discomfort was also improved compared with baseline for abdominal pain, constipation and indigestion (P < 0·05) during the kiwifruit intervention and constipation during the Metamucil® intervention (P < 0·05). This randomised controlled trial demonstrates that daily consumption of three gold-fleshed kiwifruit is associated with a significant increase of two CSBM per week and reduction in gastrointestinal discomfort in mildly constipated adults.

Helicobacter pylori Eradication Therapy Ameliorates Latent Digestive Symptoms in Chronic Atrophic Gastritis.

BACKGROUND/AIMS: This study investigated the effect of Helicobacter pylori eradication therapy on latent digestive symptoms in chronic atrophic gastritis. METHODS: We enrolled 650 health checkup patients who underwent eradication therapy for chronic gastritis and completed a self-report questionnaire before and after the treatment between January 2014 and December 2016 at the Japanese Red Cross Society Kyoto Daiichi Hospital. RESULTS: H. pylori eradication therapy for chronic atrophic gastritis improved latent digestive symptoms, including both the acid reflux and dyspepsia components in the frequency scale for the symptoms of gastroesophageal reflux disease (FSSG) scores. The effect was sustained until 1 year after the treatment. Higher FSSG scores (≥8 points) before H. pylori eradication therapy and age <70 years were significantly associated with the improvement of digestive symptoms after H. pylori eradication therapy. CONCLUSION: H. pylori eradication therapy may improve patients' quality of life through the resolution of latent abdominal symptoms.

Clinical factors associated with the symptoms of constipation in patients with diabetes mellitus: A multicenter study.

BACKGROUND AND AIM: Changes in treatment protocols for patients with diabetes mellitus (DM) may influence the functions of the digestive tract. This study examined possible clinical factors associated with the symptoms of constipation in patients with DM. METHODS: This was a multicenter study. Participants were consecutive Japanese patients undergoing treatment for type 1 or type 2 DM. Constipation was evaluated using the gastrointestinal symptom rating scale. Diabetic neuropathy was evaluated by the presence or absence of peripheral neuropathy of the lower limbs. RESULTS: Of 419 participants, 258 were men and 161 women (ratio: 1.6:1), with a mean age of 63.6 ± 12.5 years. In multivariate analysis, symptoms of constipation were significantly associated with age (odds ratio [OR] = 1.02, 95% confidence interval [CI]: 1.01-1.04, P = 0.032), lower mental component summary (OR = 3.31, 95% CI: 1.69-6.48, P < 0.001), diabetic retinopathy (OR = 1.99, 95% CI: 1.14-3.45, P = 0.015), and diabetic neuropathy (OR = 1.86, 95% CI: 1.10-3.16, P = 0.021). In patients with peripheral neuropathy of the lower limbs, regardless of the presence of other complications (diabetic nephropathy and diabetic retinopathy), the prevalence of symptoms of constipation was twice that of patients without peripheral neuropathy (40.0-49.1% vs 22.0%). Diabetic drugs were not associated with symptoms of constipation. CONCLUSIONS: Diabetic neuropathy, defined as peripheral neuropathy of the lower limbs, was significantly associated with symptoms of constipation. Peripheral neuropathy of the lower limbs is not a direct risk factor for constipation but may be a useful criterion when assessing whether constipation is associated with DM.

Absence of Post-Transplantation Encapsulating Peritoneal Sclerosis after Relatively Short Exposure to Peritoneal Dialysis: Prospective Analysis Using Repeated Abdominal CT Scanning.

BACKGROUND: Encapsulating peritoneal sclerosis (EPS) is the most severe complication of peritoneal dialysis (PD). Several retrospective reports published between 2007 and 2009 have suggested an increasing incidence of EPS occurring after kidney transplantation. We conducted a prospective observational study to determine the incidence of post-transplantation EPS and identify possible risk factors. METHODS: Consecutive PD patients undergoing kidney transplantation between 2009 and 2013 were included. Encapsulating peritoneal sclerosis was defined as gastrointestinal obstruction combined with radiological evidence of EPS. Gastrointestinal symptoms were assessed using a self-administered Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. Abdominal computed tomography (CT) was performed prospectively at 6 and 18 months post-transplantation. The primary end point was EPS during follow-up. RESULTS: Fifty-three PD patients were included (age 51 ± 14 years). Mean PD duration was 31.3 months. Peritoneal dialysis solutions low in glucose degradation products and icodextrin were used by 86.8% of patients. A fast or average-fast transport status was documented in 83.0%. After a median follow-up of 19 months, complete data of 47 patients were available for analysis. None of the patients developed clinical or radiological signs of EPS. The GSRS score improved from 1.87 to 1.55 (p = 0.024) and body weight increased from 75.9 to 78.3 kg (p = 0.003). Only 1 patient had new onset localized (< 20%) peritoneal thickening on CT 22 months post-transplantation. CONCLUSION: Post-transplantation EPS did not develop in this cohort of patients with a relatively short time of PD exposure. This suggests that these patients can be transplanted safely without concern for the development of EPS, at least within the follow-up period of 19 months.