- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00806104
Fructo-oligosaccharides and Irritable Bowel Syndrome
January 14, 2011 updated by: Beghin-Meiji
Effect of Dietary Supplementation With Fructo-oligosaccharides on Visceral Sensitivity and on Taxonomic and Functional Composition of Intestinal Microbiota of IBS Patients
Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria.
Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS).
Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- IBS subjects according to Rome III criteria
- Incomfort below or equivalent to 30mmHg during Tensostat test
- between 18 and 60 years
- no antibiotic treatment for the last 2 months
- less than 20g of dietary fibres consummed per day
- no analgesic treatment
- no treatment for intestinal transit
Exclusion Criteria:
- subjects suffering from diabetes, colic cancer, inflammatory bowel disease, dysthyroidy, Hirschprung disease, anorexia
- excessive consumption of alcohol or tobacco
- participating to another clinical study
- pregnant women
- antidepressor or anxiolytic treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Fructo-oligosaccharides
|
Dietary supplementation for 4 weeks
|
Placebo Comparator: 2
Maltodextrins
|
Dietary supplementation for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
rectal sensitivity
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
taxonomic composition of intestinal microbiota
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michel Dapoigny, MD, PhD, University Hospital, Clermont-Ferrand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
December 9, 2008
First Submitted That Met QC Criteria
December 9, 2008
First Posted (Estimate)
December 10, 2008
Study Record Updates
Last Update Posted (Estimate)
January 17, 2011
Last Update Submitted That Met QC Criteria
January 14, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FOS_QLV2
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.
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Clinical Trials on Fructo-oligosaccharides
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TereosCEN BiotechCompleted
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SyralCompletedFunctional ConstipationFrance
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Wageningen UniversityUnknown
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Baylor College of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedIrritable Bowel Syndrome (IBS)United States
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Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingProbiotics | Non-Alcoholic Fatty Liver Disease | Microbiome | Gut Microbiome | Fecal Microbiota Transplantation | Intestinal Microbiome | FMT | Non Alcoholic Steatohepatitis | PrebioticsNetherlands
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Soroka University Medical CenterCompletedAntibiotic-Associated DiarrheaIsrael
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Wageningen University and ResearchAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); FrieslandCampina...RecruitingHealthy With Hard and/or Lumpy StoolsNetherlands
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University of MinnesotaCompleted