- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00977587
Saccharomyces Cerevisiae CNCM I-3856 Treatment in Irritable Bowel Syndrome With Diarrhea (IBS-D) and Post Infective Bowel Dysfunction
Effect of Saccharomyces Cerevisiae CNCM I-3856 on Faecal Proteases and Symptoms Associated With IBS-D and Postinfective Bowel Dysfunction
Study Overview
Status
Intervention / Treatment
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 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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nottinghamshire
-
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
- Nottingham University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in faecal serine protease activity
Time Frame: at 4 and 9 weeks for study 1 and 10 weeks for study 2
|
at 4 and 9 weeks for study 1 and 10 weeks for study 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stool consistency
Time Frame: at 4 and 9 weeks for study 1 and ten weeks for study 2
|
at 4 and 9 weeks for study 1 and ten weeks for study 2
|
Stool frequency
Time Frame: at 4 and 9 weeks for study 1 and 10 weeks for study 2
|
at 4 and 9 weeks for study 1 and 10 weeks for study 2
|
Number of mucus septae per high power filed
Time Frame: at 4 and 9 weeks for study 1 and 10 weeks for study 2
|
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
Time Frame: at week one for both studies
|
at week one for both studies
|
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
|
at week 1 for both studies at week 4 and 9 for study 1 and week 10 for study 2
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robin Spiller, MB B Chir Cantab, MSc Lond, MD, Nottingham Digestive Diseases Centre and Biomedical Research Unit
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome
-
ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
-
ClasadoCR2O B.V.RecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
-
Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
-
Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
-
University of California, Los AngelesCompletedIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Mixed Bowel HabitsUnited States
-
University of ViennaCompleted
-
Thomayer University HospitalCharles University, Czech RepublicActive, not recruitingIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome MixedCzechia
-
Shahid Beheshti University of Medical SciencesCompletedIrritable Bowel DiseaseIran, Islamic Republic of
-
Universidad Autonoma de ChihuahuaNot yet recruitingIrritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
-
Vasily IsakovRussian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition...CompletedIrritable Bowel Syndrome With Constipation | Constipation-predominant Irritable Bowel SyndromeRussian Federation
Clinical Trials on Saccharomyces Cerevisiae CNCM I-3856
-
Lesaffre InternationalUniversity of Nottingham; BioFortisCompletedIrritable Bowel SyndromeFrance
-
Lesaffre InternationalCompletedConstipation-predominant Irritable Bowel SyndromeFrance
-
Hero Institute for Infant NutritionUniversidad de Murcia; University of Valencia; Universidad de GranadaCompletedConditions Influencing Health StatusSpain
-
Lesaffre InternationalBiofortis Mérieux NutriscienceCompleted
-
Ziauddin UniversityHilton PharmaCompleted
-
Lesaffre InternationalTerminated
-
Medical University of LodzCompletedHealthy | Anxiety | Stress-related Problem
-
Lesaffre InternationalEurofins OptimedTerminatedVulvo-vaginal CandidiasisFrance
-
Lesaffre InternationalCompleted
-
Lesaffre InternationalNIZO Food ResearchCompleted