Is Microbiota Community Associated With Clinical Response to a Low FODMAP Diet in Patients With Irritable Bowel Syndrome

Study Overview
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Brief Summary
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To determine the efficacy of a low FODMAP diet in IBS patients and whether gut microbiota community is associated with its efficacy.

Detailed Description
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We seek to determine whether a low FODMAPs diet decreases symptoms in irritable bowel syndrome (IBS)patients and to identify potential microbial factors related to diet efficacy. Pain symptoms, stooling characteristics, breath hydrogen, stool microbiome will be collected and/or documented in IBS patients at baseline and during one week of an low FODMAPs intervention.

Official Title
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Is Microbiota Community Associated With Clinical Response to a Low FODMAP Diet in Patients With Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: low FODMAPs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the presence of Rome III criteria for IBS ; Patients scheduled for colonoscopy examination or having negative screening examinations Aged between 18 and 65 years old Exclusion Criteria: Antibiotic, probiotic or laxative usage within 4 weeks. organic gastrointestinal diseases Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc. pregnancy or lactation. previous major or complicated abdominal surgery. severe endometriosis and dementia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBS patients<br>eat the low FODMAPs diet for one week | Dietary Supplement: low FODMAPs<br>* low FODMAPs means excluding food which contains oligosaccharides.disaccharides,monosaccharides, and polyols<br>|
| Active Comparator: healthy controls<br>eat the low FODMAPs diet for one week | Dietary Supplement: low FODMAPs<br>* low FODMAPs means excluding food which contains oligosaccharides.disaccharides,monosaccharides, and polyols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of symptom scores |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of responders |  | 3 months | 
| quality of life in IBS patients |  | 5 months | 
| microbial composition in different response to low FODMAPs |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota Community, FODMAPs, IBS