Small Intestinal Bacterial Overgrowth Obese

Gastric Bypass Clinical Trial

— SIBOB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819037
• Other study ID #: RC-P0046
• Secondary ID: 2015-A01807-42
• Status: Completed
• Phase: N/A
• Start date: May 27, 2016
• Est. completion date: October 7, 2022

Study information

• Verified date: March 2024
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• gas chromatography

• Stool analysis for detection of malabsorption

Locations

Country	Name	City	State
France	Centre Hospitalier d'Arras	Arras
France	Centre Hospitalier de Douai	Douai

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	Santelys Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in expired hydrogen H2 concentration	Measured by gas chromatography	change at baseline et up to 24 months
Secondary	Changes in digestive symptoms		change at baseline et up to 24 months
Secondary	Changes in intestinal transit	Characterisation of intestinal transit by measuring stool frequency	change at baseline et up to 24 months
Secondary	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