NCT02819037CompletedNot Applicable
Modification of Digestive Flora After Gastric Bypass : Pilot Study on Microbial Overgrowth Using Gas Chromatography
Lille Catholic University4 sites in 1 country51 target enrollmentStarted: May 27, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 51
- Locations
- 4
- Primary Endpoint
- Changes in expired hydrogen H2 concentration
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Gas chromatography and stool analysis
Experimental
gas chromatography and stool analysis for detection of malabsorption
Intervention: gas chromatography (Procedure)
Gas chromatography and stool analysis
Experimental
gas chromatography and stool analysis for detection of malabsorption
Intervention: Stool analysis for detection of malabsorption (Procedure)
Outcomes
Primary Outcomes
Changes in expired hydrogen H2 concentration
Time Frame: change at baseline et up to 24 months
Measured by gas chromatography
Secondary Outcomes
- Changes in intestinal transit(change at baseline et up to 24 months)
- Changes in malabsorption(change at baseline et up to 24 months)
- Changes in digestive symptoms(change at baseline et up to 24 months)
Investigators
Study Sites (4)
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