Upper endoscopy in elderly patients: a multicentre, cross-sectional study.

BACKGROUND: Both macroscopic and histological lesions are frequently detected at upper endoscopy in elderly patients. We assessed the prevalence of main endoscopic and histological alterations in elderly (> 65 years old) patients. METHODS: In this study, clinical, endoscopic and histological features of patients referred for upper endoscopy in clinical practice were retrieved. Both univariate and multivariate analyses were executed. Comparisons with previous data were performed. RESULTS: A total of 1336 underwent upper endoscopy in the 28 participating centres. At endoscopy, at least one macroscopic lesion was present in overall 420 (31.4%) patients. Erosive gastritis (13.3%) and erosive oesophagitis (9.8%) were the most prevalent lesions, whilst Barrett's oesophagus, gastric ulcer, duodenal ulcer and erosive duodenitis were observed in 1.8%, 2%, 1.4% and 3.1% patients, respectively. Nine (0.6%) cases of oesophageal, 25 (1.8%) gastric and 2 (0.1%) duodenal neoplasia were detected. At histology, Helicobacter pylori infection was diagnosed in 99 (15.9%) patients, and extensive precancerous lesions on gastric mucosa were detected in 80 (14.5%) patients. Endoscopic lesions were more frequent in males, at first endoscopy and in those with alarm symptoms and lower during PPI therapy. At multivariate analysis, PPI therapy significantly reduced the probability of finding endoscopic lesions (OR: 0.68, 95% CI: 0.46-0.99; P = 0.04), whilst neoplastic lesions were associated with presence of alarm symptoms (OR: 1.5, 95% CI: 1.1-2.1; P = 0.005). CONCLUSIONS: We found that the frequency of erosive and neoplastic lesions remained high in elderly patients, whilst the prevalence of both H. pylori infection and peptic ulcer was decreased.

Upper Gastrointestinal Endoscopy Quality in Italy: A Nationwide Study.

BACKGROUND AND AIMS: International guidelines advise improving esophagogastroduodenoscopy (EGD) quality in Western countries, where gastric cancer is still diagnosed in advanced stages. This nationwide study investigated some indicators for the quality of EGD performed in endoscopic centers in Italy. METHODS: Clinical, endoscopic, and procedural data of consecutive EGDs performed in one month in the participating centers were reviewed and collected in a specific database. Some quality indicators before and during endoscopic procedures were evaluated. RESULTS: A total of 3,219 EGDs performed by 172 endoscopists in 28 centers were reviewed. Data found that some relevant information (family history for GI cancer, smoking habit, use of proton pump inhibitors) were not collected before endoscopy in 58.5-80.7% of patients. Pre-endoscopic preparation for gastric cleaning was routinely performed in only 2 (7.1%) centers. Regarding the procedure, sedation was not performed in 17.6% of patients, and virtual chromoendoscopy was frequently (>75%) used in only one (3.6%) center. An adequate sampling of the gastric mucosa (i.e., antral and gastric body specimens) was heterogeneously performed, and it was routinely performed only by 23% of endoscopists, and in 14.3% centers. CONCLUSIONS: Our analysis showed that the quality of EGD performed in clinical practice in Italy deserves to be urgently improved in different aspects.

Endoscopic characterization of neoplastic and non-neoplastic lesions in inflammatory bowel disease: systematic review in the era of advanced endoscopic imaging.

Background: Current guidelines strongly recommend the use of validated classifications to support optical diagnosis of lesions with advanced endoscopic imaging in the lower gastrointestinal tract. However, the optimal strategy in inflammatory bowel disease (IBD) is still a matter of debate. Objectives: To analyze the accuracy of endoscopic classifications or single predictors for in vivo lesion characterization during endoscopic surveillance of IBD with advanced endoscopic imaging. Design: Systematic review. Data sources and methods: Medline and PubMed were used to extract all studies which focused on lesion characterization of neoplastic and non-neoplastic lesions in IBD. The diagnostic accuracy of endoscopic classifications and single endoscopic predictors for lesion characterization were analyzed according to type of patients, lesions, and technology used. When available, the rates of true and false positives or negatives for neoplasia were pooled and the sensitivity (SE), specificity (SP), positive predictive value, and negative predictive value (NPV) were calculated. Results: We included 35 studies (2789 patients; 5925 lesions - 1149 neoplastic). Advanced endoscopic imaging included dye-based chromoendoscopy, virtual chromoendoscopy (VCE), magnification and high-definition endoscopy, confocal laser endomicroscopy (CLE), endocytoscopy, and autofluorescence imaging. The Kudo classification of pit patterns was most frequently used, with pooled SE 83%, SP 83%, and NPV 95%. The endoscopic criteria with the highest accuracy, with minimum SE ⩾ 90%, SP ⩾ 80%, and NPV ⩾ 90% were: the Kudo-IBD classification used with VCE (Fuji Intelligent Color Enhancement and i-SCAN); combined irregular surface and vascular patterns used with narrow band imaging; the Mainz classification used with CLE. Multiple clinical and technical factors were found to influence the accuracy of optical diagnosis in IBD. Conclusion: No single endoscopic factor has yet shown sufficient accuracy for lesion characterization in IBD surveillance. Conventional classifications developed in the non-IBD setting have lower accuracy in IBD. The use of new classifications adapted for IBD (Kudo-IBD), and new technologies based on in vivo microscopic analysis show promise.

A multicenter survey on endoscopic retrograde cholangiopancreatography during the COVID-19 pandemic in northern and central Italy.

Background and study aims COVID-19 has dramatically impacted endoscopy practice because upper endoscopy procedures can be aerosol-generating. Most elective procedures have been rescheduled. Endoscopic retrograde cholangiopancreatography (ERCP) is frequently performed in emergency or urgent settings in which rescheduling is not possible. We evaluated the impact of the COVID-19 pandemic on ERCP in Italy during the SARS-CoV-2 lockdown, in areas with high incidence of COVID-19. Patients and methods We performed a retrospective survey of centers performing ERCP in high COVID-19 prevalence areas in Italy to collect information regarding clinical data from patients undergoing ERCP, staff, case-volume and organization of endoscopy units from March 8, 2020 to April 30, 2020. Results We collected data from 31 centers and 804 patients. All centers adopted a triage and/or screening protocol for SARS-CoV-2 and performed follow-up of patients 2 weeks after the procedure. ERCP case-volume was reduced by 44.1 % compared to the respective 2019 timeframe. Of the 804 patients undergoing ERCP, 22 (2.7 %) were positive for COVID-19. Adverse events occurred at a similar rate to previously published data. Of the patients, endoscopists, and nurses, 1.6 %, 11.7 %, and 4.9 %, respectively, tested positive for SARS-CoV-2 at follow up. Only 38.7 % of centers had access to a negative-pressure room for ERCP. Conclusion The case-volume reduction for ERCP during lockdown was lower than for other gastrointestinal endoscopy procedures. No definitive conclusions can be drawn about the percentage of SARS-CoV-2-positive patients and healthcare workers observed after ERCP. Appropriate triage and screening of patients and adherence to society recommendations are paramount.

Infection Control Practices and Outcomes of Endoscopy Units in the Lombardy Region of Italy: A Survey From the Italian Society of Digestive Endoscopy During COVID-19 Spread.

GOALS: The present survey from the Italian Society of Digestive Endoscopy (SIED-Società Italiana di Endoscopia Digestiva) was aimed at reporting infection control practice and outcomes at Digestive Endoscopy Units in a high-incidence area. BACKGROUND: Lombardy was the Italian region with the highest coronavirus disease-2019 (COVID-19) prevalence, at the end of March 2020 accounting for 20% of all worldwide deaths. Joint Gastro-Intestinal societies released recommendations for Endoscopy Units to reduce the risk of the contagion. However, there are few data from high-prevalence areas on adherence to these recommendations and on their efficacy. METHODS: A survey was designed by the Lombardy section of SIED to analyze (a) changes in activity and organization, (b) adherence to recommendations, (c) rate of health care professionals' (HCP) infection during the COVID-19 outbreak. RESULTS: In total, 35/61 invited centers (57.4%) participated; most modified activities were according to recommendations and had filtering face piece 2/filtering face piece 3 and water-repellent gowns available, but few had negative-pressure rooms or provided telephonic follow-up; 15% of HCPs called in sick and 6% had confirmed COVID-19. There was a trend (P=0.07) toward different confirmed COVID-19 rates among endoscopists (7.9%), nurses (6.6%), intermediate-care technicians (3.4%), and administrative personnel (2.2%). There was no correlation between the rate of sick HCPs and COVID-19 incidence in the provinces and personal protective equipment availability and use, whereas an inverse correlation with hospital volume was found. CONCLUSIONS: Adherence to recommendations was rather good, though a minority were able to follow all recommendations. Confirmed COVID-19 seemed higher among endoscopists and nurses, suggesting that activities in the endoscopy rooms are at considerable viral spread risk.

Plastic Biliary Stent Migration During Multiple Stents Placement and Successful Endoscopic Removal Using Intra-Stent Balloon Inflation Technique: A Case Report and Literature Review.

BACKGROUND: Late migration of a plastic biliary stent after endoscopic placement is a well known complication, but there is little information regarding migration of a plastic stent during multiple stents placement. CASE REPORT: A white man was hospitalized for severe jaundice due to neoplastic hilar stenosis. Surgical eligibility appeared unclear on admission and endoscopy was carried out, but the first stent migrated proximally at the time of second stent insertion. After failed attempts with various devices, the migrated stent was removed successfully through cannulation with a dilation balloon. CONCLUSIONS: The migration of a plastic biliary stent during multiple stents placement is a possible complication. In this context, extraction can be very complicated. In our patient, cannulation of a stent with a dilation balloon was the only effective method.

Large Bowel Obstruction Due to a Big Gallstone Successfully Treated with Endoscopic Mechanical Lithotripsy.

Colonic gallstone ileus in an uncommon mechanical bowel obstruction caused by intraluminal impaction of one or more gallstones. The surgical management of gallstone ileus is complex and is potentially of high risk. There have been reports of gallstone extractions using various endoscopic modalities to relieve the obstruction. In this report we present the technique employed to successfully perform a mechanical lithotripsy and extraction of a large gallstone embedded in a sigmoid colon affected by diverticular stenosis. We passed through the stenosis with a 11.3 mm videoscope with 3.7 mm channel. A large lithotripsy extraction basket was used to catch and break up the stone and fragments were removed using the same basket. The patient was discharged asymptomatic three days after the procedure. Using appropriate devices mechanical lithotripsy is a safe and effective method to treat colonic obstruction and avoid surgery in the setting of gallstone ileus even in case of big stones.

Correlation between chronic treatment with proton pump inhibitors and bacterial overgrowth in the stomach: any possible beneficial role for selected lactobacilli?

BACKGROUND: The inhibition of physiological gastric acid secretion induced by proton pump inhibitors (PPIs), the most widely used drugs in the world, may cause a significant bacterial overgrowth in the gastrointestinal tract as a side effect. This study was undertaken firstly to correlate PPI intake with concentration of specific bacterial groups in the stomach as well as possible Helicobacter pylori infection, and secondly to assess the efficacy of the 4 lactobacilli L. rhamnosus LR06 (DSM 21981), L. pentosus LPS01 (DSM 21980), L. plantarum LP01 (LMG P-21021), and L. delbrueckii subsp. delbrueckii LDD01 (DSM 22106) in the restoration of a physiological gastric barrier. METHODS: Total bacteria, sulphite-reducing bacteria (SRB), total coliforms, and total lactobacilli were quantified in samples of gastric juice from 29 subjects taking PPIs for at least 3 months compared with 36 control subjects. The presence of H. pylori was also assessed.The subjects treated with PPIs with a concentration of total bacteria in the gastric juice higher than 10(5) cells/mL were selected for an intervention study with the 4 lactobacilli L. rhamnosus LR06, L. pentosus LPS01, L. plantarum LP01, and L. delbrueckii subsp. delbrueckii LDD01. After 15 days of supplementation, the same bacterial groups were quantified to compare these values with the baseline. RESULTS: No significant correlation was found between the presence of H. pylori and PPI intake. The baseline quantification of bacterial groups (log10 CFU/mL of gastric juice, PPI group vs. control) showed: total bacteria 8.35 versus 3.95 (P<0.001); total coliforms 4.98 versus 2.35 (P<0.001); SRB 5.71 versus 2.28 (P=0.065); and total lactobacilli 3.85 versus 2.20 (P=0.005). After 15 days of treatment with the 4 lactobacilli, the quantification of bacterial groups gave the following results: total bacteria 7.91 versus 8.35 at time zero (P=0.002); total coliforms 4.21 versus 4.98 at time zero (P<0.001); SRB 4.94 versus 5.71 at baseline (P=0.060); and total lactobacilli 7.20 versus 3.85 at baseline (P=0.040). CONCLUSIONS: A significant impairment of intragastric acidity is sufficient to induce a relevant bacterial overgrowth, with particular reference to SRB and total coliforms. This fact can contribute to an increase in the risk of infections and intestinal diseases. It could be crucial to restore the physiological "gastric barrier." The 2-week supplementation with the 4 lactobacilli tested proved to be effective in significantly reducing total bacteria and coliforms in the gastric milieu in subjects chronically treated with PPIs. It is therefore possible to hopothesise a beneficial role for such lactobacilli in clinical practice.

Assessment of the capability of a gelling complex made of tara gum and the exopolysaccharides produced by the microorganism Streptococcus thermophilus ST10 to prospectively restore the gut physiological barrier: a pilot study.

BACKGROUND: Leaky gut, or intestinal permeability, is the phenomenon of the gut wall exhibiting increased absorbency. It is pretty well recognised that an altered or damaged bowel lining or gut wall may result from unbalanced diet, parasites, infection, or medications and that this allows substances such as toxins, microbes, undigested food, or waste to leak through. As a natural consequence, this prompts the body to initiate an immune reaction leading to potentially severe health conditions. Different strategies may be used to improve, at least temporarily, the physiological intestinal barrier. The use of specific beneficial microorganisms, such as lactobacilli and bifidobacteria, has been suggested as an innovative tool to counteract an improper level of intestinal permeability. The association of bacteria with specific gelling agents, such as gums, may represent an improvement since these molecules are able to form hydrophilic gels that distribute uniformly over the inner intestinal surface. This pilot study was undertaken to evaluate intestinal permeability in subjects treated with a gelling complex, an association of tara gum and the microorganism Streptococcus thermophilus ST10 (DSM 25246), which has a well-demonstrated in vitro ability to synthesise and secrete exopolysaccharides (EPSs). METHODS: Twenty-five healthy subjects were enrolled in this human intervention, double-blind, placebo-controlled, pilot trial (age between 21 and 57 y, mean 37.7±11.2). Subjects were then randomised into 2 groups: group A (13 subjects) was given an active formulation containing 250 mg of tara gum and 1 billion viable cells of S. thermophilus ST10, whereas group B (12 subjects) was given a placebo formulation. All the subjects participating in the study were directed to take 1 dose per day for 30 consecutive days. The presence and concentration of exopolysaccharides (EPSs) in the faeces was determined at time 0 (d0), after 30 days of treatment (d30), and at the end of the 2-week follow-up period (d45). The monosaccharide composition of EPSs was used to quantify the possible contribution of tara gum to the amount of polysaccharides detected in the faecal material. Intestinal permeability was evaluated at the same time by means of the lactitol/mannitol ratio (small intestine permeability) and sucralose concentration (colonic permeability) in urine specimens sampled after specified times. A statistical comparison was made between the concentration of EPSs, the lactulose/mannitol ratio, and the amount of excreted sucralose in the 2 groups at d0, d30, and d45. RESULTS: In the active group, supplementation with S. thermophilus ST10 and tara gum was able to significantly increase the faecal EPSs concentration compared with placebo (from 0.169 mg/g to 0.633 mg/g after 30 d, P<0.001). An interesting decrease in intestinal permeability, both of the small bowel and in the colon, was also recorded. The L/M ratio diminished from 0.021 in the active group to 0.014 and 0.015 after 30 and 45 days, respectively (P=0.045 and P=0.033 compared with placebo). The sucralose concentration decreased from 35.8 mg to 27.9 mg and 29.1 mg (P=0.038 and P=0.026 compared with placebo) at the end of the supplementation period and after the follow-up, respectively. No significant differences were recorded in the placebo after 30 days or at the end of the follow-up. CONCLUSIONS: The association of the EPSs produced by S. thermophilus ST10 and tara gum seems capable of significantly improving the intestinal functional barrier in healthy subjects. A wider study in subjects presenting impaired gut permeability would be useful in the future to confirm the positive results from this pilot trial. In any case, our findings are consistent with the parallel increase in exopolysaccharide concentration in the faecal material, thus suggesting the effective ability of the strain used to secrete EPSs in the gut lumen. An innovative approach of this type may be useful in helping to restore the physiological barrier by means of a merely natural and mechanical action.

The innovative potential of Lactobacillus rhamnosus LR06, Lactobacillus pentosus LPS01, Lactobacillus plantarum LP01, and Lactobacillus delbrueckii Subsp. delbrueckii LDD01 to restore the "gastric barrier effect" in patients chronically treated with PPI: a pilot study.

BACKGROUND: Gastroesophageal reflux disease is a very widespread condition. In Europe, it is estimated that about 175 million people suffer from this disease and have to chronically take drugs to increase gastric pH. The proton pump inhibitors (PPIs) such as omeprazole, lansoprazole, and esomeprazole are the most widely used drug typology in this regard. However, the inhibition of normal gastric acid secretion has important side effects, the most important being bacterial overgrowth in the stomach and duodenum with a concentration of >105 viable cells/mL. As a major consequence of this, many harmful or even pathogenic bacteria contained in some foods could survive the gastric transit and colonize either the stomach itself, the duodenum, or the gut, where they could establish acute and even chronic infections with unavoidable consequences for the host's health. In other words, the "gastric barrier effect" is strongly reduced or even disrupted. To date, there are no real strategies to deal with this widespread, although still relatively little known, problem. The aim of this study was to confirm the gastric bacterial overgrowth in long-term PPI consumers and to assess the efficacy of some probiotic bacteria, belonging to both genera Lactobacillus and Bifidobacterium, in the reduction of gastric and duodenal bacterial overgrowth, therefore partially restoring the gastric barrier effect against foodborne pathogenic bacteria. METHODS: For this purpose, probiotics with a strong demonstrated inhibitory activity on gram-negative bacteria, such as Escherichia coli, were tested in a human intervention trial involving a total of 30 subjects treated with PPIs for either 3 to 12 consecutive months (short-term) or >12 consecutive months (long-term). An additional 10 subjects not taking PPIs were enrolled and used as a control group representing the general population. Four selected probiotics Probiotical SpA (Novara, Italy), namely Lactobacillus rhamnosus LR06 (DSM 21981), Lactobacillus pentosus LPS01 (DSM 21980), Lactobacillus plantarum LP01 (LMG P-21021), and Lactobacillus delbrueckii subsp. delbrueckii LDD01 (DSM 22106) were administered for 10 days to 10 subjects treated with PPIs for >12 months (group B). In the 60 mg formulation, N-acetylcysteine was included as well in light of its well-known mechanical effects on bacterial biofilms. Gastroscopies were performed at the beginning of the study (d0) in all the groups (A, B, C, and D) and after 10 days (d10) in group B only; that is, at the end of probiotics intake. The total viable cells and total Lactobacillus were quantified in gastric juice and duodenal brushing material from all subjects. The results were compared among all the groups and with the control subjects (group D) to confirm the bacterial overgrowth. A comparison was made also between d0 and d10 in group B to quantify the efficacy of the 4 probiotics administered for 10 days. Fecal samples were collected from all groups at d0, including subjects not treated with PPIs, and in group B only at d10. Specific bacterial classes, namely enterococci, total coliforms, E. coli, molds, and yeasts were quantified in all fecal specimens. RESULTS: The results collected confirmed the strong bacterial overgrowth in the stomach and duodenum of people treated with PPIs compared with subjects with a normal intragastric acidity. It is also worth noting that the bacterial cell counts in subjects who underwent a long-term treatment with a PPI were greater than the results from subjects taking these drugs for 3 to 12 months. The intake of 4 specific probiotic strains with a marked antagonistic activity towards 5 E. coli bacteria, including the enterohaemorrhagic O157:H7 strain, and an effective amount of N-acetylcysteine (NAC) was able to significantly reduce bacterial overgrowth in long-term PPI-treated subjects. Total lactobacilli represented the major percentage of bacterial counts, thus demonstrating the ability of such bacteria to colonize the stomach and the duodenum, at least temporarily, and to consequently restore the gastric barrier effect. A significant decrease in fecal enterococci, total coliforms, E. coli, molds, and yeasts in subjects treated with PPIs was recorded at the end of probiotics supplementation (d10) compared with baseline (d0) in group B. This is a further confirmation of the barrier effect also exerted at the stomach level. CONCLUSIONS: PPIs are the most widely sold and used drugs in the world. However, the chronic use of these pharmacological molecules exposes the subject to the risk of foodborne infections as most pathogens are able to survive the gastric transit in a condition of significantly decreased acidity.

Comparison of the kinetics of intestinal colonization by associating 5 probiotic bacteria assumed either in a microencapsulated or in a traditional, uncoated form.

BACKGROUND: Beneficial findings concerning probiotics are increasing day by day. However, one of the most important parameters able to significantly affect the probiotic value of a microorganism is its survival during the transit through the stomach and the duodenum. Some techniques may be applied that aim to improve this parameter, but microencapsulation of bacterial cells remains one of the most important. A recent study assessed the kinetics of intestinal colonization by a mixture of 2 probiotic strains, given either in a microencapsulated or in a traditional, uncoated form. METHODS: A comparison between the intestinal colonization by associating 5 microencapsulated bacteria and the same uncoated strains was performed by a double-blind, randomized, cross-over study. The study (December 2007 to January 2009) involved 53 healthy volunteers. In particular, subjects were divided into 2 groups: group A (27 subjects) was given a mix of probiotic strains Probiotical S.p.A. (Novara, Italy), Lactobacillus acidophilus LA02 (DSM 21717), Lactobacillus rhamnosus LR04 (DSM 16605), L. rhamnosus GG, or LGG (ATCC 53103), L. rhamnosus LR06 (DSM 21981), and Bifidobacterium lactis BS01 (LMG P-21384) in an uncoated form, whereas group B (26 subjects) received the same strains microencapsulated with a gastroprotected material. The uncoated strains were administered at 5×109 cfu/strain/d (a total of 25×109 cfu/d) for 21 days, whereas the microencapsulated bacteria were given at 1×109 cfu/strain/d (a total of 5×109 cfu/d) for 21 days. At the end of the first period of supplementation with probiotics, a 3-week wash-out phase was included in the study setting. At the end of the wash-out period, the groups crossed over their treatment regimen; that is, group A was administered the microencapsulated bacteria and group B the uncoated bacteria. The administered quantities of each strain were the same as the first treatment. A quantitative evaluation of intestinal colonization by probiotics, either microencapsulated or uncoated, was undertaken by examining fecal samples at the beginning of the study (time 0), after 10 days and after 21 days of each treatment period. In particular, fecal total Lactobacilli, heterofermentative Lactobacilli, and total Bifidobacteria were quantified at each checkpoint. A genomic analysis of an appropriate number of colonies was performed to quantify individual L. rhamnosus strains among heterofermentative Lactobacilli. RESULTS: A statistically significant increase in the fecal amounts of total Lactobacilli, heterofermentative Lactobacilli, and total Bifidobacteria was registered in both groups at the end of each supplementation period compared with d0 or d42 (group A: P=0.0002, P=0.0001, and P<0.0001 at d21, P=0.0060, P=0.0069, and P<0.0001 at d63 for total Lactobacilli, heterofermentative Lactobacilli, and Bifidobacteria, respectively; group B: P=0.0002, P=0.0006, and P<0.0001 at d21, P=0.0015, P=0.0016, and P<0.0001 at d63 for total Lactobacilli, heterofermentative Lactobacilli, and Bifidobacteria, respectively), confirming the ability of each strain in the administered composition to colonize the human gut, whether supplemented in a gastroprotected or in a traditional freeze-dried form. On the contrary, subjects receiving microencapsulated bacteria reported a kinetics of intestinal colonization that was entirely comparable with those who were given uncoated strains at a 5 times higher amount. CONCLUSIONS: The microencapsulation technique used in this study is a valid approach aimed to significantly improve the survival of strains during gastroduodenal transit, thus enhancing their probiotic value and allowing the use of a 5 times lower amount.

Is microencapsulation the future of probiotic preparations? The increased efficacy of gastro-protected probiotics.

In a recent publication we assessed the kinetics of intestinal colonization by microencapsulated probiotic bacteria in comparison with the same strains given in an uncoated form. It's well known, in fact, that microencapsulation of probiotics with specific materials is able to confer a significant resistance to gastric juice, thus protecting the cells during the gastric and duodenal transit and enhancing the probiotic efficacy of any supplementation. In any case, this was the first study reporting the fecal amounts of probiotics administered in a coated, protected form compared with traditional, uncoated ones. Here we discuss additional in vitro data of resistance of the same bacteria to gastric juice, human bile and pancreatic secretion and correlate them with the results of in vivo gut colonization.

The use of probiotics in healthy volunteers with evacuation disorders and hard stools: a double-blind, randomized, placebo-controlled study.

BACKGROUND: Evacuation disorders and hard stools are common in industrialized countries, affecting on average 12% to 17% of the adult healthy population at any age. Dietary supplementation with probiotic microorganisms may be useful in reducing the disorder. METHODS: We performed a double-blind, randomized, placebo-controlled study to evaluate the effectiveness of 2 different probiotic blends, either mixed Lactobacillus plantarum LP01 (LMG P-21021) and Bifidobacterium breve BR03 (DSM 16604) or Bifidobacterium animalis subspecies lactis BS01 (LMG P-21384), in the management of evacuation disorders and intestinal discomfort. In a period of 5 years (2003 to 2008), the study involved 300 healthy volunteers (151 males and 149 females; age 24 to 71 y) with evacuation disorders and hard stools. In particular, subjects were divided into 3 groups: 80 subjects in the group A received placebo, 110 subjects in the group B received mixed L. plantarum LP01 and B. breve BR03 (2.5 x 10 colony-forming units/d of each strain), and 110 subjects in the group C received B. animalis subsp. lactis BS01 (5 x 10 colony-forming units/d) for 30 days. At the beginning of the observational study, the healthy status of volunteers was evaluated by a complete, laboratory and ultrasound study of the abdomen. The physical examination was repeated after 15 and 30 days. In particular, the main troubles typically associated with evacuation disorders and hard stools as well as abdominal bloating were considered as parameters of interest. Exclusion criteria were items of gastrointestinal diseases and antibiotics intake. RESULTS: Subjects treated with the mixed probiotic strains L. plantarum LP01 and B. breve BR03 or B. animalis subsp. lactis BS01 reported a significant improvement in the number of weekly bowel movements and in the main troubles associated with evacuations, particularly consistency of feces and ease of expulsion. Discomfort items such as abdominal bloating and anal itching, burning, or pain also registered a relevant improvement in the active groups receiving probiotics. CONCLUSIONS: The intake of an effective amount of mixed L. plantarum LP01 and B. breve BR03 or B. animalis subsp. lactis BS01 for 30 days is able to significantly relieve the evacuation disorders and hard stools, thus providing a useful tool for the management of such condition, which is particularly widespread in industrialized countries at any age.

In vitro sensitivity of probiotics to human pancreatic juice.

BACKGROUND: The resistance of gut flora with probiotic activity to pancreatic juice is usually tested with artificial pancreatic fluid. Previous studies evaluated the sensitivity of diverse probiotics to human gastric and biliary secretion; none tested the resistance of probiotics to human pancreatic juice. As most bacteria sensitive to artificial pancreatic fluid in vitro have a high rate of isolation from feces, the resistance to human pancreatic juice could be higher. AIM: The aim of this study was to compare the sensitivity of different strains of probiotics to artificial and human pancreatic juice. MATERIALS AND METHODS: The viability of 8 strains of Lactobacillus and 4 strains of Bifidobacterium was tested with standard artificial and human pancreatic juice withdrawn from 16 patients during endoscopic retrograde cholangiopancreatography procedure. The mortality rate (%) of various bacteria was measured after 5, 30, and 60 minutes contact time. The results were normalized for mortality rate induced by hypotonic condition and time exposure to 37 degrees C. RESULTS: When incubated with artificial and human pancreatic juice, the mortality rate of all strains of Lactobacillus at 5, 30, and 60 minutes was 10.1 versus 7.6, 20.5 versus 19.7, and 28.6 versus 29.8, respectively; whereas the mortality rate of all strains of Bifidobacterium was 8.0 versus 9.2, 33.3 versus 28.9, and 42.2 versus 44.4, respectively. CONCLUSIONS: All the tested strains were sensitive to artificial and human pancreatic juice depending on time contact. Bifidobacterium strains seem to be more sensitive than Lactobacillus strains in particular at higher time contact. There is no significant difference between sensitivity to simulated and human pancreatic juice. For this reason, probiotics activity may be tested with artificial pancreatic fluid using a standardized, easier, and less costly procedure.