Saccharomyces Cerevisiae CNCM I-3856 Treatment in Irritable Bowel Syndrome With Diarrhea (IBS-D) and Post Infective Bowel Dysfunction
Irritable Bowel Syndrome
Post Infective Bowel Dysfunction
Drug: Saccharomyces Cerevisiae CNCM I-3856
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Saccharomyces Cerevisiae CNCM I-3856 on Faecal Proteases and Symptoms Associated With IBS-D and Postinfective Bowel Dysfunction|
- Change in faecal serine protease activity [ Time Frame: at 4 and 9 weeks for study 1 and 10 weeks for study 2 ] [ Designated as safety issue: No ]
- Stool consistency [ Time Frame: at 4 and 9 weeks for study 1 and ten weeks for study 2 ] [ Designated as safety issue: No ]
- Stool frequency [ Time Frame: at 4 and 9 weeks for study 1 and 10 weeks for study 2 ] [ Designated as safety issue: No ]
- Number of mucus septae per high power filed [ Time Frame: at 4 and 9 weeks for study 1 and 10 weeks for study 2 ] [ Designated as safety issue: No ]
- In vitro effect of Saccharomyces cerevisiae CNCM I-3856 supernatant on IBS-D faecal proteases [ Time Frame: at week one for both studies ] [ Designated as safety issue: No ]
- Bacterial diversity assessed by similarity indices [ Time Frame: at week 1 for both studies at week 4 and 9 for study 1 and week 10 for study 2 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Saccharomyces Cerevisiae CNCM I-3856
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
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
Placebo Comparator: placebo
Capsules will contain 500 mg of the following formulation and will not contain Saccharomyces cerevisiae CNCM I-3856:
Placebo: Capsules will contain 500 mg of the following formulation and will not contain Saccharomyces cerevisiae CNCM I-3856:
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 active) with a 4 week washout period in between. The order with which they receive the treatment will be decided randomly. The study starts with a screening period lasting 1 week. If, at the end of screening, they are still eligible they will be enrolled and start randomised treatment. Once the participant has received both treatments the study finishes.
Study 2 is a parallel group design. Subjects who submit a stool sample which proves to be positive for Campylobacter will be sent an invitation to take part. All subjects will be asked to complete a bowel symptom questionnaire and attend to provide a stool sample (enrolment visit). A blood sample will be taken at this visit.
After a further 4 weeks subjects will attend again, bringing with them a stool sample and stool symptom diaries. A blood sample will be taken. At this time, if they are still symptomatic they will be invited to take part in the randomised placebo controlled trial taking yeast or placebo for 5 weeks, after which they will again attend with stool diaries and provide a final stool and blood sample. The blood sample will be used to see, if antibodies to C. jejuni antigens predicts recovery and whether this is altered by yeast treatment. Those that are asymptomatic will not take part in the RCT but will return at 9 weeks with a further stool and blood sample.
We will also invite 15 healthy volunteers, free from gastrointestinal complaints to attend on 3 occasions mimicking visits 1-3 by providing stool and blood samples so we can define the normal variability in stool composition in health. As with the other subjects they will be required to avoid antibiotics and probiotics during the study.
End of Studies The last visit of the last subject.
SELECTION AND WITHDRAWAL OF PARTICIPANTS Recruitment Study 1 Participants for study 1 will be recruited from Professor Spiller's patients who have previously taken part in research studies and have indicated that they would like to be contacted about future relevant research projects. This secure password protected database is held within the Nottingham Digestive Diseases Centre and contains patient's names and addresses to allow mailing of invitation letter.
The investigator or their nominee, i.e. a member of the participant's usual care team, will make the initial approach to the patient by letter to the patient using a ethically approved invitation letter enclosing a copy of the information sheet and inform the participant of all aspects pertaining to participation in the study.
Study 2 Currently all patients who submit a stool sample positive for C jejuni to the Public Health laboratory receive a letter form Professor Neal asking for details about eating out and pet's illnesses as part of routine surveillance. This letter will have an information sheet enclosed and an invitation to take part in Study 2 We will also recruit 15 healthy volunteers who have responded to an advert displayed on public notice boards at University Hospital Nottingham. On responding, they will then be sent an information sheet and details of the study and who to contact if they are interested in taking part.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977587
|Nottingham University Hospital|
|Nottingham, Nottinghamshire, United Kingdom, NG7 2UH|
|Principal Investigator:||Robin Spiller, MB B Chir Cantab, MSc Lond, MD||Nottingham Digestive Diseases Centre and Biomedical Research Unit|