Saccharomyces Cerevisiae CNCM I-3856 Treatment in Irritable Bowel Syndrome With Diarrhea (IBS-D) and Post Infective Bowel Dysfunction

Summary

Irritable Bowel Syndrome (IBS) is a common condition characterised by abdominal pain or discomfort and altered bowel habit affecting up to 10% of the population. There are several groups of patients that are based on differing bowel patterns including IBS with diarrhea (IBS-D) and those with post infective IBS (PI-IBS) whose symptoms begin after an acute infection. Saccharomyces cerevisiae, the yeast used in bread making has been shown to reduce the duration of infectious diarrhoea. Part of the benefit maybe that it can destroy bacterial toxins. Recent studies suggest an increase in proteases (chemicals which breakdown proteins) in the stool of patients with IBS-D. The investigators think that this yeast may benefit patients with IBS-D and PI-IBS by reducing the amount of protease in stool. This is important because proteases have been shown to be potentially important in generating some of the discomfort experienced by patients. The investigators will study patients with chronic IBS-D who will receive 2 weeks treatment with the yeast or placebo followed by a 4 week gap and then a further 2 week treatment with placebo or the yeast, with the treatments allocated randomly. The investigators will also study 30 subjects who still have persistent loose bowel function 6 weeks after an infection with Campylobacter jejuni, one of the commonest causes of gastroenteritis in the UK. Subjects will be randomised to take either the yeast or placebo for 4 weeks . In both studies, the investigators will examine the effect of treatment on stool proteases, stool frequency and consistency and abdominal discomfort; the investigators will also take blood samples to examine some aspects of immune system function. The results of the study may suggest how yeast provides a benefit in patients with IBS and diarrhea and will provide data for a larger clinical trial.

Conditions

• Irritable Bowel Syndrome
• Post Infective Bowel Dysfunction

Interventions

DRUG

Saccharomyces Cerevisiae CNCM I-3856

Saccharomyces cerevisiae CNCM I-3856, 500 mg per capsule (5 X109 living cells). Living cells are estimated by the method of colony forming units (cfu).subjects will take 1 capsule twice a day

DRUG

placebo

Placebo: Capsules will contain 500 mg of the following formulation and will not contain Saccharomyces cerevisiae CNCM I-3856: * Calcium phosphate, Dibasic 472.0 mg * Maltodextrin DE14 112.1 mg * Vegetal magnesium stearate 5.9 mg subjects will take one capsule twice a day

Sponsors & Collaborators

• Lesaffre International

  collaborator INDUSTRY

• University of Nottingham

  lead OTHER

Principal Investigators

• Robin Spiller, MB B Chir Cantab, MSc Lond, MD · Nottingham Digestive Diseases Centre and Biomedical Research Unit

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2012-01-31

Completion

2012-07-31

Countries

• United Kingdom

Study Locations