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Small Intestinal Bacterial Overgrowth Obese

NCT ID: NCT02819037

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-27

Study Completion Date

2022-10-07

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.

Detailed Description

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Conditions

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Gastric Bypass Blind Loop Syndrome Bacterial Overgrowth Syndrome Chromatography, Gas

Keywords

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Gastric bypass Intestinal Bacterial Overgrowth Syndrome Gas chromatography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Gas chromatography and stool analysis

gas chromatography and stool analysis for detection of malabsorption

Group Type EXPERIMENTAL

gas chromatography

Intervention Type PROCEDURE

Stool analysis for detection of malabsorption

Intervention Type PROCEDURE

Interventions

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gas chromatography

Intervention Type PROCEDURE

Stool analysis for detection of malabsorption

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santelys Association

OTHER

Sponsor Role collaborator

Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent Florent, MD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Arras

Locations

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Centre Hospitalier d'Arras

Arras, , France

Site Status

Centre Hospitalier de Douai

Douai, , France

Site Status

Countries

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France

References

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Florent V, Dennetiere S, Gaudrat B, Andrieux S, Mulliez E, Norberciak L, Jacquez K. Prospective Monitoring of Small Intestinal Bacterial Overgrowth After Gastric Bypass: Clinical, Biological, and Gas Chromatographic Aspects. Obes Surg. 2024 Mar;34(3):947-958. doi: 10.1007/s11695-024-07080-0. Epub 2024 Feb 1.

Reference Type RESULT
PMID: 38300481 (View on PubMed)

Other Identifiers

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2015-A01807-42

Identifier Type: OTHER

Identifier Source: secondary_id

RC-P0046

Identifier Type: -

Identifier Source: org_study_id