Status:
WITHDRAWN
Saccharomyces Cerevisiae CNCM I-3856 Treatment in Irritable Bowel Syndrome With Diarrhea (IBS-D) and Post Infective Bowel Dysfunction
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Lesaffre International
Conditions:
Irritable Bowel Syndrome
Post Infective Bowel Dysfunction
Eligibility:
All Genders
18-75 years
Phase:
NA
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 t...
Detailed Description
The participant involvement in study 1 \& 2 will last 15 \& 9 weeks respectively. Study1 has a cross over design so each participant will receive two 2 week treatment periods (1 of placebo and 1 of ac...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00977587
Start Date
January 1 2011
End Date
July 1 2012
Last Update
June 20 2017
Active Locations (1)
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1
Nottingham University Hospital
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH