Small Intestinal Bacterial Overgrowth Obese

Not Applicable

Completed

• Conditions: Chromatography, Gas; Bacterial Overgrowth Syndrome; Gastric Bypass; Blind Loop Syndrome
• Interventions: Procedure: gas chromatography; Procedure: Stool analysis for detection of malabsorption

• Registration Number: NCT02819037
• Lead Sponsor: Lille Catholic University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-27
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-30
• Primary Completion: 2022-10-07
• Study Completion: 2022-10-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gas chromatography and stool analysis	gas chromatography	gas chromatography and stool analysis for detection of malabsorption
Gas chromatography and stool analysis	Stool analysis for detection of malabsorption	gas chromatography and stool analysis for detection of malabsorption

Primary Outcome Measures

Name	Time	Method
Changes in expired hydrogen H2 concentration	change at baseline et up to 24 months	Measured by gas chromatography

Secondary Outcome Measures

Name	Time	Method
Changes in intestinal transit	change at baseline et up to 24 months	Characterisation of intestinal transit by measuring stool frequency
Changes in malabsorption	change at baseline et up to 24 months	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
Changes in digestive symptoms	change at baseline et up to 24 months

Trial Locations

Locations (2)

Centre Hospitalier d'Arras; 🇫🇷 Arras, France

Centre Hospitalier de Douai; 🇫🇷 Douai, France