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      The utility of probiotics in the treatment of irritable bowel syndrome: a systematic review.

      The American Journal of Gastroenterology
      Bifidobacterium, Humans, Irritable Bowel Syndrome, drug therapy, Probiotics, therapeutic use, Treatment Outcome

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          Abstract

          Irritable bowel syndrome (IBS) is a common disorder and available therapies have limited efficacy. Mucosal inflammation and alterations in gut microflora may contribute to the development of IBS symptoms, and researchers have hypothesized that probiotics might improve these symptoms. The aim of this study was to perform a systematic review of randomized controlled trials (RCTs) evaluating the efficacy, safety, and tolerability of probiotics in the treatment of IBS. Comprehensive literature searches of multiple databases were performed. Study selection criteria were as follows: (i) RCTs, (ii) adults with IBS defined by Manning or Rome II criteria, (iii) single or combination probiotic vs. placebo, and (iv) improvement in IBS symptoms and/or decrease in frequency of adverse events reported. Data about study design and results were extracted in duplicate using standardized data extraction forms. Owing to variability in outcome measures, quantitative pooling of data was not feasible. A total of 16 RCTs met selection criteria. Of those, 11 studies showed suboptimal study design with inadequate blinding, inadequate trial length, inadequate sample size, and/or lack of intention-to-treat analysis. None of the studies provided quantifiable data about both tolerability and adverse events. Bifidobacterium infantis 35624 showed significant improvement in the composite score for abdominal pain/discomfort, bloating/distention, and/or bowel movement difficulty compared with placebo (P<0.05) in two appropriately designed studies. No other probiotic showed significant improvement in IBS symptoms in an appropriately designed study. B. infantis 35624 has shown efficacy for improvement of IBS symptoms. Most RCTs about the utility of probiotics in IBS have not used an appropriate study design and do not adequately report adverse events. Therefore, there is inadequate data to comment on the efficacy of other probiotics. Future probiotic studies should follow Rome II recommendations for appropriate design of an RCT.

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          Activated mast cells in proximity to colonic nerves correlate with abdominal pain in irritable bowel syndrome.

          The mechanisms underlying abdominal pain perception in irritable bowel syndrome (IBS) are poorly understood. Intestinal mast cell infiltration may perturb nerve function leading to symptom perception. We assessed colonic mast cell infiltration, mediator release, and spatial interactions with mucosal innervation and their correlation with abdominal pain in IBS patients. IBS patients were diagnosed according to Rome II criteria and abdominal pain quantified according to a validated questionnaire. Colonic mucosal mast cells were identified immunohistochemically and quantified with a computer-assisted counting method. Mast cell tryptase and histamine release were analyzed immunoenzymatically. Intestinal nerve to mast cell distance was assessed with electron microscopy. Thirty-four out of 44 IBS patients (77%) showed an increased area of mucosa occupied by mast cells as compared with controls (9.2% +/- 2.5% vs. 3.3 +/- 0.8%, respectively; P < 0.001). There was a 150% increase in the number of degranulating mast cells (4.76 +/- 3.18/field vs. 2.42 +/- 2.26/field, respectively; P = 0.026). Mucosal content of tryptase was increased in IBS and mast cells spontaneously released more tryptase (3.22 +/- 3.48 pmol/min/mg vs. 0.87 +/- 0.65 pmol/min/mg, respectively; P = 0.015) and histamine (339.7 +/- 59.0 ng/g vs. 169.3 +/- 130.6 ng/g, respectively; P = 0.015). Mast cells located within 5 microm of nerve fibers were 7.14 +/- 3.87/field vs. 2.27 +/- 1.63/field in IBS vs. controls (P < 0.001). Only mast cells in close proximity to nerves were significantly correlated with severity and frequency of abdominal pain/discomfort (P < 0.001 and P = 0.003, respectively). Colonic mast cell infiltration and mediator release in proximity to mucosal innervation may contribute to abdominal pain perception in IBS patients.
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            AGA technical review on irritable bowel syndrome.

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              Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome.

              Probiotic bacteria exhibit a variety of properties, including immunomodulatory activity, which are unique to a particular strain. Thus, not all species will necessarily have the same therapeutic potential in a particular condition. We have preliminary evidence that Bifidobacterium infantis 35624 may have utility in irritable bowel syndrome (IBS). This study was designed to confirm the efficacy of the probiotic bacteria B. infantis 35624 in a large-scale, multicenter, clinical trial of women with IBS. A second objective of the study was to determine the optimal dosage of probiotic for administration in an encapsulated formulation. After a 2-wk baseline, 362 primary care IBS patients, with any bowel habit subtype, were randomized to either placebo or freeze-dried, encapsulated B. infantis at a dose of 1 x 10(6), 1 x 10(8), or 1 x 10(10), cfu/mL for 4 wk. IBS symptoms were monitored daily and scored on to a 6-point Likert scale with the primary outcome variable being abdominal pain or discomfort. A composite symptom score, the subject's global assessment of IBS symptom relief, and measures of quality of life (using the IBS-QOL instrument) were also recorded. B. infantis 35624 at a dose of 1 x 10(8) cfu was significantly superior to placebo and all other bifidobacterium doses for the primary efficacy variable of abdominal pain as well as the composite score and scores for bloating, bowel dysfunction, incomplete evacuation, straining, and the passage of gas at the end of the 4-wk study. The improvement in global symptom assessment exceeded placebo by more than 20% (p < 0.02). Two other doses of probiotic (1 x 10(6) and 1 x 10(10)) were not significantly different from placebo; of these, the 1 x 10(10) dose was associated with significant formulation problems. No significant adverse events were recorded. B. infantis 35624 is a probiotic that specifically relieves many of the symptoms of IBS. At a dosage level of 1 x 10(8) cfu, it can be delivered by a capsule making it stable, convenient to administer, and amenable to widespread use. The lack of benefits observed with the other dosage levels of the probiotic highlight the need for clinical data in the final dosage form and dose of probiotic before these products should be used in practice.
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                Author and article information

                Journal
                19277023
                10.1038/ajg.2009.25

                Chemistry
                Bifidobacterium,Humans,Irritable Bowel Syndrome,drug therapy,Probiotics,therapeutic use,Treatment Outcome

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