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

• Status: Withdrawn
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Nottingham
• Collaborator: Lesaffre International

Criteria

Inclusion Criteria:

Study 1 and 2:

• Male or female aged 18-75 years

• Subjects who are able to give informed consent

Study 1:

• IBS-D patients meeting Rome III Criteria

Study 2:

• Subjects with stool cultures positive for Campylobacter jejuni

• Healthy volunteer controls

Exclusion Criteria:

• Subjects that, in the opinion of the investigator, are considered unsuitable.

• Subjects who have had abdominal surgery which may cause bowel symptoms similar to IBS (Please note, appendicectomy and cholecystectomy is not an exclusion).

• Subjects with a known intolerance to yeast.

• Subjects taking immunosuppressant medication, e.g. long term steroids, or who might otherwise be immunocompromised.

• Subjects who have had a recent course of antibiotics (in the last 28 days).

• Subjects unable to stop anti-diarrhoeal drugs.

• Subjects currently participating in another clinical trial or who have been in a trial in the previous three months.

• Patients with known gastrointestinal diseases including coeliac disease and inflammatory bowel disease.

• Regular consumption of drugs known to alter bowel habit (see concomitant medication).