Small Intestinal Bacterial Overgrowth Obese (SIBOB)

March 25, 2024 updated by: Lille Catholic University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Arras, France, 62022
        • Centre Hospitalier D'arras
      • Douai, France, 59507
        • Centre Hospitalier de Douai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in expired hydrogen H2 concentration
Time Frame: change at baseline et up to 24 months
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
Time Frame: change at baseline et up to 24 months
change at baseline et up to 24 months
Changes in intestinal transit
Time Frame: change at baseline et up to 24 months
Characterisation of intestinal transit by measuring stool frequency
change at baseline et up to 24 months
Changes in malabsorption
Time Frame: 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
change at baseline et up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Collaborators

Santelys Association

Investigators

  • Study Director: Vincent Florent, MD, PhD, Centre Hospitalier Arras

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2016

Primary Completion (Actual)

October 7, 2022

Study Completion (Actual)

October 7, 2022

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimated)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-P0046
  • 2015-A01807-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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