Small Intestinal Bacterial Overgrowth Obese

Study Overview
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Brief Summary
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The objective of this research is to determine the incidence of microbial overgrowth of the small intestine before and after a gastric bypass. For this purpose, the study is based on the analysis of the expired hydrogen H2 with gas chromatography before surgery and at 1, 3, 6, 12, 18 and 24 months.

Official Title
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Modification of Digestive Flora After Gastric Bypass : Pilot Study on Microbial Overgrowth Using Gas Chromatography

Conditions
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Gastric Bypass, Blind Loop Syndrome, Bacterial Overgrowth Syndrome, Chromatography, Gas

Intervention / Treatment
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* Procedure: gas chromatography
* Procedure: Stool analysis for detection of malabsorption


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe obesity (BMI>35kg/m² with at least one comorbidity or BMI>40kg/m² without comorbidity) and after medical care for at least 6 months Patient who will follow bariatric surgery by bypass gastric Social insurance affiliation Signature of the informed consent Exclusion Criteria: Contraindication criteria for bariatric surgery (cognitive or mental severe disorders, severe and non-stabilized eating disorders, etc.) Chronic inflammatory bowel disease (Crohn's disease, hemorrhagic rectocolitis) Previous intestinal surgery Antibiotic periodicity treatment of less than 3 months Other diseases responsible for bacterial overgrowth Pregnancy or breastfeeding

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gas chromatography and stool analysis<br>gas chromatography and stool analysis for detection of malabsorption | Procedure: gas chromatography<br> <br> Procedure: Stool analysis for detection of malabsorption<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in expired hydrogen H2 concentration | Measured by gas chromatography | change at baseline et up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in digestive symptoms |  | change at baseline et up to 24 months | 
| Changes in intestinal transit | Characterisation of intestinal transit by measuring stool frequency | change at baseline et up to 24 months | 
| Changes in malabsorption | Detection of lipids, vitamins (A, B1, B9, B12, D, E), zinc, magnesium, phosphorus, serum iron and protein balance (albumin, prealbumin, CRP) in order to diagnosis the presence of malabsorption | change at baseline et up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric bypass, Intestinal Bacterial Overgrowth Syndrome, Gas chromatography