Continuous clinical remission with biologics in ulcerative colitis: the 'AURORA' comparison study.

OBJECTIVES: Comparative trials among biological drugs for the treatment of ulcerative colitis (UC) provided conflicting results. After patent expire of infliximab originator, adalimumab, infliximab biosimilar, golimumab and vedolizumab have been approved in Italy.We compared the efficacy of these four biologics in UC according to the concept of continuous clinical remission (CCR). METHODS: In a retrospective, multicentre study, all UC patients treated with adalimumab, infliximab biosimilar, golimumab or vedolizumab between 2014 and 2019 were included. All drugs were compared to each other according to the 1-year CCR rate, defined as Mayo partial score ≤2, with bleeding subscore = 0, without any relapse or optimization with dose escalation, topical treatments or steroid use after first clinical remission. RESULTS: Four-hundred sixteen patients (adalimumab = 90, infliximab biosimilar = 105, golimumab = 79, vedolizumab = 142) were included. CCR was achieved in similar percentages among the groups (33%, 37%, 28%, 37%, respectively). All drugs were equivalent in biologic-naive patients, while vedolizumab was better than a second anti-TNFα in prior anti-TNFα agent failures. No differences were found according to type of adverse events or severe adverse events. CONCLUSIONS: Based on a strict definition of clinical remission, all biologics appear equally effective at 1 year. Changing to vedolizumab is more effective than switching to another anti-TNFα in TNFα failures.

Use of rapid reading software to reduce capsule endoscopy reading times while maintaining accuracy.

BACKGROUNDS AND AIMS: A typical capsule endoscopy (CE) case generates tens of thousands of images, with abnormalities often confined to a just few frames. Omni Mode is a novel EndoCapsule software algorithm (Olympus, Tokyo, Japan) that proposes to intelligently remove duplicate images while maintaining accuracy in lesion detection. METHODS: This prospective multicenter study took place across 9 European centers. Consecutive, unselected CE cases were read conventionally in normal mode, with every captured frame reviewed. Cases were subsequently anonymized and randomly allocated to another center where they were read using Omni Mode. Detected lesions and reading times were recorded, with findings compared between both viewing modes. The clinical significance of lesions was described according to the P classification (P0, P1, and P2). Where a discrepancy in lesion detection in either mode was found, expert blinded review at a consensus meeting was undertaken. RESULTS: The patient population undergoing CE had a mean age of 49.5 years (range, 18-91), with the investigation of anemia or GI bleeding accounting for 71.8% of cases. The average small-bowel transit time was 4 hours, 26 minutes. The mean reading time in normal mode was 42.5 minutes. The use of Omni Mode was significantly faster (P < .0001), with an average time saving of 24.6 minutes (95% confidence interval, 22.8-26.9). The 2127 lesions were identified and classified according to the P classification as P0 (1234), P1 (656), and P2 (237). Lesions were identified using both reading modes in 40% (n = 936), and 1186 lesions were identified by either normal or Omni Mode alone. Normal mode interpretation was associated with 647 lesions being missed, giving an accuracy of .70. Omni Mode interpretation led to 539 lesions being missed, with an accuracy of .75. There was no significant difference in clinical conclusions made between either reading mode. CONCLUSIONS: This study shows that CE reading times can be reduced by an average of 40%, without any reduction in clinical accuracy.

Novel endoscopic over-the-scope clip system.

This paper reports our experience with a new over-the-scope clip in the setting of recurrent bleeding and oesophageal fistula. We treated five patients with the over-the-scope Padlock Clip™. It is a nitinol ring, with six inner needles preassembled on an applicator cap, thumb press displaced by the Lock-It™ delivery system. The trigger wire is located alongside the shaft of the endoscope, and does not require the working channel. Three patients had recurrent bleeding lesions (bleeding rectal ulcer, post polypectomy delayed bleeding and duodenal Dieulafoy's lesion) and two patients had a persistent respiratory-esophageal fistula. In all patients a previous endoscopic attempt with standard techniques had been useless. All procedures were conducted under conscious sedation but for one patient that required general anaesthesia due to multiple comorbidities. We used one Padlock Clip™ for each patient in a single session. Simple suction was enough in all of our patients to obtain tissue adhesion to the instrument tip. A remarkably short application time was recorded for all cases (mean duration of the procedure: 8 min). We obtained technical and immediate clinical success for every patient. No major immediate, early or late (within 24 h, 7 d or 4 wk) adverse events were observed, over follow-up durations lasting a mean of 109.4 d. One patient, treated for duodenal bulb bleeding from a Dieulafoy's lesion, developed signs of mild pancreatitis 24 h after the procedure. The new over-the-scope Padlock Clip™ seems to be simple to use and effective in different clinical settings, particularly in "difficult" scenarios, like recurrent bleeding and respiratory-oesophageal fistulas.

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.

Narrow band imaging vs. high definition colonoscopy for detection of colorectal adenomas in patients with positive faecal occult blood test: a randomised trial.

BACKGROUND: The impact of narrow band imaging in improving the adenoma detection rate in a screening scenario is still unclear. AIM: To evaluate whether narrow band imaging compared with high definition white light colonoscopy can enhance the adenoma detection rate during screening colonoscopy. METHODS: Consecutive patients presenting for screening colonoscopy were included into this study and were randomly assigned to the narrow band imaging group (Group 1) or standard colonoscopy group (Group 2). Primary end point was the adenoma detection rate and secondary aim was the detection rate of advanced adenomas. RESULTS: Overall, 117 patients were allocated to Group 1 and 120 to Group 2. Both the adenoma detection rate and the detection rate of advanced adenomas were not significantly different between the two groups (respectively, 52.1% vs. 55%, RR=0.95, 95% CI 0.75-1.20; 32.5% vs. 44.2%, RR=0.74, 95% CI 0.53-1.02). No significant difference between the proportions of polypoid and flat adenomas was found. Male gender, no prior history of screening, and endoscopist's adenoma detection rate were independent predictive factors of higher advanced adenoma detection rate. CONCLUSIONS: In a screening scenario, narrow band imaging did not improve the adenoma nor advanced adenoma detection rates compared to high definition white light colonoscopy.

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.

Evaluation of the intestinal colonization by microencapsulated probiotic bacteria in comparison with the same uncoated strains.

BACKGROUND: Beneficial findings concerning probiotics are increasing day by day. However, one of the most important parameter which affects the probiotic activity of a microorganism is its survival during the gastroduodenal transit. Some microencapsulation techniques could be applied to bacterial cells to improve this parameter. METHODS: A comparison between the intestinal colonization by microencapsulated bacteria and the same not microencapsulated strains has been conducted in a double blind, randomized, cross-over study. The study (April to July 2005) involved 44 healthy volunteers. In particular, participants were divided into 2 groups: group A (21 participants) received a mix of probiotic strains Lactobacillus plantarum LP01 (LMG P-21021) and Bifidobacterium breve BR03 (DSM 16604) in an uncoated form, group B (23 participants) was given the same strains microencapsulated with a gastroresistant material. The not microencapsulated strains were administered at 5 x 10(9) colony forming units/strain/d for 21 days, whereas the microencapsulated bacteria were given at 1 x 10(9) colony forming units/strain/d for 21 days. At the end of the first period of treatment with probiotics a 3 weeks washout phase has been included in the study protocol. At the end of the washout period the groups were crossed: in detail, group A had the microencapsulated and group B the uncoated bacteria. The administered amounts of each strain were the same as the first treatment. The quantitative evaluation of intestinal colonization by strains microencapsulated or not microencapsulated was made by fecal samples examination at the beginning of the clinical trial, after 10 and 21 days of each treatment period. In particular, fecal heterofermentative Lactobacilli and Bifidobacteria have been counted. RESULTS: A statistically significant increase in the fecal amounts of Lactobacilli and Bifidobacteria was recorded in both groups at the end of each treatment compared with d0 or d42 (P<0.0001 and P<0.0001 at d21, P<0.0001 and P<0.0001 at d63 for Lactobacilli and Bifidobacteria, respectively), confirming the ability of the 2 strains to colonize the human gut, either in a gastroprotected form or not. Participants treated with the microencapsulated bacteria reported a kinetics of intestinal colonization quite similar to participants who received not coated strains. CONCLUSIONS: Probiotics are able to exert many different beneficial effects on the human host. These effects are mediated by the number of viable cells which reach the gut. The microencapsulation technique used in this study is a valid strategy to significantly improve gastroresistance of strains, thus enhancing their probiotic activity and allowing the use of a 5 times lower amount.

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.

The eradication of Helicobacter pylori is affected by body mass index (BMI).

BACKGROUND: Bariatric surgeons often advocate preoperative Helicobacter pylori (H. pylori) testing and eradication because of the increased risk of postoperative ulcers and foregut symptoms in H. pylori-positive patients. The aim of this pilot study was to evaluate whether body mass index (BMI) might influence the success rate of eradication. METHODS: Eighty one nondiabetic naïve H. pylori-positive patients were divided into two groups according to their BMI, with 41 in the control group (normal BMI) and 40 in the overweight/obese group (BMI > or = 25). Gastroscopy was performed and multiple biopsies were obtained from the antrum and corpus. Both groups were given a triple therapy consisting of pantoprazole 40 mg for 2 weeks plus amoxicillin 1 g tris in die (t.i.d), and clarithromycin 250 mg t.i.d, for the first week of treatment. Eradication was confirmed by the (13)C-urea breath test at 3 months. RESULTS: Successful eradication was observed in 55.0% of the overweight/obese group compared with 85.4% [p < 0.005; odds ratio (OR): 4.77; 95% confidence interval (CI): 1.64-13.87]. The distribution of age, gender, and smoking, as well as the proportion with corpus predominant gastritis (41.4% and 35.0% in control and overweight/obese groups, respectively), did not differ significantly between the two groups. Regression analysis showed that risk factors for treatment failure were BMI (p < 0.02) with an OR of 1.06 (95% CI: 1.01-1.11) and corpus-predominant gastritis (p < 0.001) with an OR of 8.74 (95% CI: 2.48-30.8). CONCLUSION: Overweight/obese nondiabetic patients showed a significantly lower rate of eradication rate of H. pylori infection than controls. BMI and corpus-predominant gastritis appear to be independent risk factors for eradication failure.