Randomized controlled pilot study: effect of carrageenan emulsifier on inflammation and gastrointestinal symptoms in quiescent ulcerative colitis.

Background: Animal models have provided some evidence of the pro-inflammatory effects of the commonly used emulsifier carrageenan. However, the effects of food-grade carrageenan among people with ulcerative colitis (UC) are largely unknown. Methods: A randomized, placebo-controlled cross-over study comparing high molecular carrageenan and oat-based beta-glucan preparation (placebo) among patients (n = 7) with quiescent UC was performed. Primary endpoint was Simple Clinical Colitis Activity Index (SCCAI) at the end of the treatment (7th day). Secondary analyses included biochemical biomarkers of inflammation, intestinal permeability, detoxification of intestinal lipopolysaccharide (LPS), and gastrointestinal symptoms measured by visual analog scale. Results: There were no statistically significant differences in SCCAI or any biochemical markers between carrageenan and placebo periods, nor were there any significant differences when comparing either period to baseline. Gastrointestinal symptoms were higher during the placebo period; the sum of all symptoms and borborygmi was statistically significantly higher at the end of the placebo period than at the end of the carrageenan period (20.8 ± 18.6 vs. 13.3 ± 16.4; P = 0.031, and 29.7 ± 28.6 vs. 17.9 ± 23.6; P = 0.016). Conclusions: Our study suggests that at least short-term usage of food-grade carrageenan is safe among people with UC, but given the limitations of the current study, robust human studies are still urgently needed.

Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) has been associated with microbial dysbiosis. AIM: To investigate the efficacy of faecal microbiota transplantation (FMT) in the treatment of IBS. METHODS: Forty-nine IBS patients were randomised to receive autologous or allogenic FMT via colonoscopy. The primary endpoint was a sustained, minimum of 50-point, reduction in the IBS Symptom Severity Score. The secondary outcomes were levels of anxiety and depression, changes in quality of life, gut microbiota and faecal water content as assessed with validated questionnaires, intestinal microbiota composition and stool dry weight. RESULTS: The primary endpoint was not achieved in either group. However, there was a transient reduction in the mean IBS Symptom Severity Score in the FMT group at 12 weeks after treatment as compared to baseline (P = 0.01). The groups did not differ in the number of patients achieving clinical response at 12 weeks. In the FMT-treated patients, microbial composition had changed to resemble that of the donor and the stool water content decreased significantly compared to baseline. The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms. CONCLUSIONS: FMT provided only a transient relief of symptoms, although it induced a sustained alteration in the microbiota of IBS patients. Therefore, FMT delivered by a single infusion via colonoscopy cannot be recommended as a treatment for IBS in clinical practice. ClinicalTrials.Org, Trial registration number: NCT03561519.

Randomised clinical trial: effect of low-FODMAP rye bread versus regular rye bread on the intestinal microbiota of irritable bowel syndrome patients: association with individual symptom variation.

BACKGROUND: A low intake of Fermentable, Oligo-, Di-, Mono-saccharides and Polyols (FODMAPs) is effective in the symptom control of irritable bowel syndrome (IBS) patients but may exert negative effects on the intestinal microbiota. The microbial effects of increasing regular or non-FODMAP fibre sources are largely unknown. Furthermore, it is not known if the baseline microbiota composition is associated with individual symptom control during the consumption of different rye products in IBS patients. Our objective was to evaluate whether increased consumption of low-FODMAP rye bread or regular rye bread for 4 weeks would alter the intestinal microbiota composition of IBS patients following their habitual diet, and whether these changes associate to symptoms and/or the baseline microbiota. METHODS: The study was conducted as a randomized double blind controlled cross-over study (n = 50). Microbiota was analysed by 16S rRNA gene sequencing and associated with gastrointestinal symptoms. Both microbial changes and their associations to symptoms were secondary outcomes. RESULTS: The consumption of the test breads did not alter microbiota diversity. Compared to baseline, consumption of the low FODMAP rye bread decreased the abundance of Bacteroides, Flavonifractor, Holdemania, Parasutterella and Klebsiella and showed a trend towards increased bifidobacteria, whereas the regular rye bread decreased the abundance of Flavonifractor. When comparing between the two test breads, Klebsiella was decreased after low-FODMAP rye bread intake. Patients whose symptoms decreased during the low-FODMAP rye bread displayed more Blautia and less Barnesiella at baseline. CONCLUSIONS: Consumption of low-FODMAP rye bread had modest, potentially beneficial effects on patients' microbiota while increasing their intake of fibre substantially. The baseline microbiota composition was associated with the variable degrees of symptom relief experienced by the patients. Consumption of a low-FODMAP rye bread might be one way to increase dietary fibre intake and improve the mild dysbiosis often observed among patients with IBS. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02161120. Retrospectively registered 11 June 2014.

Low-FODMAP vs regular rye bread in irritable bowel syndrome: Randomized SmartPill® study.

AIM: To compare the effects of regular vs low-FODMAP rye bread on irritable bowel syndrome (IBS) symptoms and to study gastrointestinal conditions with SmartPill®. METHODS: Our aim was to evaluate if rye bread low in FODMAPs would cause reduced hydrogen excretion, lower intraluminal pressure, higher colonic pH, different transit times, and fewer IBS symptoms than regular rye bread. The study was a randomized, double-blind, controlled cross-over meal study. Female IBS patients (n = 7) ate study breads at three consecutive meals during one day. The diet was similar for both study periods except for the FODMAP content of the bread consumed during the study day. Intraluminal pH, transit time, and pressure were measured by SmartPill, an indigestible motility capsule. RESULTS: Hydrogen excretion (a marker of colonic fermentation) expressed as area under the curve (AUC)(0-630 min) was [median (range)] 6300 (1785-10800) ppm∙min for low-FODMAP rye bread and 10 635 (4215-13080) ppm∙min for regular bread (P = 0.028). Mean scores of gastrointestinal symptoms showed no statistically significant differences but suggested less flatulence after low-FODMAP bread consumption (P = 0.063). Intraluminal pressure correlated significantly with total symptom score after regular rye bread (ρ = 0.786, P = 0.036) and nearly significantly after low-FODMAP bread consumption (ρ = 0.75, P = 0.052). We found no differences in pH, pressure, or transit times between the breads. Gastric residence of SmartPill was slower than expected. SmartPill left the stomach in less than 5 h only during one measurement (out of 14 measurements in total) and therefore did not follow on par with the rye bread bolus. CONCLUSION: Low-FODMAP rye bread reduced colonic fermentation vs regular rye bread. No difference was found in median values of intraluminal conditions of the gastrointestinal tract.

Irritable bowel syndrome symptom severity improves equally with probiotic and placebo.

AIM: To determine the effects of Lactobacillus acidophilus NCFM on irritable bowel syndrome (IBS) symptoms and quality of life (QoL). METHODS: In this randomized triple-blind trial, adult IBS volunteers who were recruited according to Rome III criteria received 109 or 1010 colony-forming units of NCFM or placebo daily for 12 wk. IBS Symptom Severity Score (IBS-SSS), which constituted the primary outcome, and secondary outcomes, including individual IBS symptoms, IBS-related QoL questionnaire, anxiety and depression, defecation frequency, and stool consistency, were assessed at baseline at the end of the 8-wk run-in period, after 4 and 12 wk of intervention, and after a 4-wk washout. RESULTS: A total of 340 of 391 randomized volunteers completed the trial. IBS-SSS improved over 12 wk of treatment in all treatment groups, decreasing by a mean ± SD of 44.0 ± 80.2, 50.8 ± 82.4, and 48.3 ± 72.2 in the placebo, active low-dose, and active high-dose groups, respectively. Similarly, secondary outcomes did not differ between treatment groups. However, in a post hoc analysis of volunteers with moderate to severe abdominal pain at baseline (VAS > 35/100), the treatment significantly reduced the sensation of abdominal pain. Pain scores fell by 20.8 ± 22.8, 29.4 ± 17.9, and 31.2 ± 21.9 in the placebo, active low-dose, and active high-dose groups, respectively (P value for placebo vs combined active doses = 0.0460). CONCLUSION: NCFM alleviates moderate to severe abdominal pain, consistent with earlier observations of this strain mitigating visceral pain through increased analgesic receptor expression.

Does oral α-galactosidase relieve irritable bowel symptoms?

OBJECTIVE: Abdominal bloating is reported by a majority of irritable bowel syndrome (IBS) patients. Excess colonic fermentation may cause gaseous symptoms. Several foodstuffs contain oligosaccharides with an α-galactosidic linkage that is resistant to mammalian hydrolases. Assisted hydrolysis by exogenous α-galactosidase enzyme (AG) could offer a way of controlling IBS symptoms by reducing colonic fermentation and gas production. The aim of this study was to assess the effect of AG on symptom severity and quality of life in IBS patients with abdominal bloating or flatulence. METHODS: A total of 125 subjects with IBS received AG or placebo at meals for 12 weeks. IBS-Symptom Severity Score (IBS-SSS) and quality of life (QoL) were assessed at baseline, during the treatment and at 4-week follow-up. RESULTS: AG showed a trend toward a more prominent decrease in IBS-SSS. The responder rate at week 16 was higher for the AG group. No difference was detected in QoL between AG and placebo groups. A total of 25 patients (18 in AG group and 7 in placebo group, p = 0.016) withdrew from the study. Abdominal pain and diarrhea were more often reported as reason for withdrawal in AG group. CONCLUSIONS: We found no evidence to support the use of AG routinely in IBS patients. Improvement of clinical response at 4-week follow-up may suggest a long-term effect of unknown mechanism, but could also be attributed to non-responder drop out. Gastrointestinal (GI) side effects may be a coincidence in this study, but irritation of GI tract by AG administration cannot be excluded.

The burden of inflammatory bowel disease on health care utilization and quality of life.

OBJECTIVE: The aim of this study was to explore the utilization of health services by Finnish adults with inflammatory bowel disease (IBD) and to assess the associated demographic and health-related quality of life (HRQoL) factors. MATERIAL AND METHODS: 556 Finnish IBD patients eligible for reimbursement for IBD medication according to the Social Insurance Institution in Finland answered our postal cross-sectional survey. The study questionnaire included questions about demographic characteristics of the patients, health care resource use, and HRQoL. The number of doctor visits was compared with those of irritable bowel syndrome patients. RESULTS: During the previous year, more than three quarters of the respondents reported disturbing IBD symptoms. The majority (64%) had seen a doctor due to their IBD, women more often than men (p < 0.001). The use of health services did not differ between diagnostic (Crohn's disease or ulcerative colitis) or age groups, marital status, education, or time elapsed since diagnosis. Women were absent from work more frequently than men (p = 0.01). The amount of physician visits, work absenteeism, and a higher amount of undergone procedures were related to impaired HRQoL (p < 0.001 on all accounts). CONCLUSIONS: Despite comprehensive public health services and specialized care for IBD patients in Finland, a majority expressed disturbing IBD symptoms. Since the amount of physician visits, work absenteeism and a higher amount of procedures were related to a diminished HRQoL, the patients who are most often met by professional caregivers are often those whose HRQoL needs to be more adequately addressed.

[Treatment of severe constipation]. / Vaikean ummetuksen hoito.

Commonly used therapeutic products in constipation, i.e. fiber supplements and laxatives, are not sufficiently effective for intractable constipation. Biofeedback therapy is utilized in functional obstructed defecation syndrome. Botulin injections into the levator muscle have been described to be beneficial. For some patients, retrograde rectal lavage is sufficient. Slow-transit constipation can also be treated by applying sacral nerve stimulation as well as antegrade lavage through a colonic stoma made into the proximal part of the large intestine. Surgical treatment can be offered for selected patients having a mechanical defecation block. Resection of the bowel is the most common surgical treatment.

Societal costs for irritable bowel syndrome--a population based study.

OBJECTIVE: Irritable bowel syndrome (IBS) is associated with increased use of health care services. This study aims to estimate the costs of IBS in relation to differing diagnostic criteria of IBS, duration of symptoms, gender, and age. MATERIAL AND METHODS: A two-phase postal survey. Questionnaire I covering gastrointestinal (GI) symptoms by Manning and Rome II criteria was mailed to 5000 randomly selected adults. Questionnaire II, mailed to those fulfilling IBS criteria of Questionnaire I, recorded data on physician visits, medications, and diagnostic procedures performed. RESULTS: Proportion of GI consulters was 48% (95% CI 41-55%) and 32% (95% CI 28-36%) for Rome II and Manning groups. Annual GI related individual costs were euro 497 (95% CI euro 382-621) and euro 295 (95% CI euro 246-347) by Rome II and Manning criteria. Societal GI costs were euro 82 million and euro 154 million by Rome II and Manning criteria. Direct non-GI costs amounted to euro 43 million and euro 126 million by Rome II and Manning criteria. Duration of GI symptoms, gender, or age had no impact on GI costs. CONCLUSIONS: IBS incurs substantial GI and non-GI costs corresponding to a share of up to 5% of the national direct outpatient and medicine expenditures. The more restrictive Rome II criteria identify an IBS population incurring higher GI related individual costs than Manning criteria. Costs due to GI endoscopies are not lower for those with a long history of symptoms suggesting that guideline recommendations for avoiding repeated diagnostic procedures may not be followed.

[Functional disorders of the digestive tract]. / Toiminnalliset vatsavaivat.

The most common functional disorders of the digestive tract include the irritable bowel syndrome, functional dyspepsia, functional constipation and diarrhea. In addition to gastrointestinal symptoms, the patients exhibit other symptoms, particularly depression and anxiety, more frequently than in somatic bowel diseases. During therapy it is important to inform the patient about the benign nature of the symptoms and to screen for possible factors that exacerbate the symptoms. Most patients will manage without continuous medication. According to the leading symptom, medication is usually directed towards pain or motility disorder.

Comorbidity and use of health-care services among irritable bowel syndrome sufferers.

OBJECTIVE: Patients suffering from irritable bowel syndrome (IBS) have more somatic and psychiatric comorbidity and use more health-care services for comorbid conditions than do other patients. Little is known about the frequency of comorbid symptoms among IBS sufferers in the general population and their influence on use of health-care facilities. The objective of this study was to compare the frequency of somatic and psychiatric symptoms between IBS sufferers and controls in the general population, and to study how comorbidity rates are distributed among consulters and non-consulters and how they predict the use of health care-services. MATERIAL AND METHODS: By means of a questionnaire sent to 5000 randomly selected adults IBS was identified according to the Rome II criteria. The questionnaire also covered upper GI symptoms, non-GI somatic symptoms, depression and anxiety. A logistic regression analysis with 26 variables was carried out to determine the independent predictors of health-care seeking for GI and non-GI complaints. RESULTS: The response rate was 73% and prevalence of IBS 5.1% (95% CI 4.4-5.8%). Dyspeptic symptoms, somatic extra-GI symptoms and psychiatric symptoms were reported by 45%, 69% and 51% of IBS sufferers, respectively, and 6%, 35% and 27%, of controls, respectively. Visiting a physician because of GI complaints was associated with disturbing abdominal symptoms, but not with depression or anxiety. Of the present GI conditions, only dyspeptic symptoms were associated with an increased consultation rate also for non-GI complaints. CONCLUSIONS: In the general population, both IBS consulters and non-consulters demonstrate high rates of comorbidity. Seeking health care for abdominal complaints is associated with abdominal symptoms rather than psychiatric comorbidity.