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

NCT00977587 | Withdrawn

• 1 other identifier: 09075
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

irritable bowel syndrome; faecal serine proteases

Outcome Measures

Primary Outcomes (1)

• Change in faecal serine protease activity

  at 4 and 9 weeks for study 1 and 10 weeks for study 2

Secondary Outcomes (5)

• Stool consistency

  at 4 and 9 weeks for study 1 and ten weeks for study 2

• Stool frequency

  at 4 and 9 weeks for study 1 and 10 weeks for study 2

• Number of mucus septae per high power filed

  at 4 and 9 weeks for study 1 and 10 weeks for study 2

• In vitro effect of Saccharomyces cerevisiae CNCM I-3856 supernatant on IBS-D faecal proteases

  at week one for both studies

• Bacterial diversity assessed by similarity indices

  at week 1 for both studies at week 4 and 9 for study 1 and week 10 for study 2

Study Arms (2)

Saccharomyces Cerevisiae CNCM I-3856

ACTIVE COMPARATOR

2 weeks of treatment with Saccharomyces Cerevisiae CNCM I-3856 1 capsule twice a day, 500 mg per capsule (5 X109 living cells). Living cells are estimated by the method of colony forming units (cfu).

Drug: Saccharomyces Cerevisiae CNCM I-3856

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Saccharomyces Cerevisiae CNCM I-3856 DRUG

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

Saccharomyces Cerevisiae CNCM I-3856

placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nottingham: lead
• Lesaffre International: collaborator

Study Sites (1)

Nottingham University Hospital

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Robin Spiller, MB B Chir Cantab, MSc Lond, MD

  Nottingham Digestive Diseases Centre and Biomedical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 20, 2017

Record last verified: 2012-01

Locations

GB (1)