NCT02819037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2022

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

6.4 years

First QC Date

June 21, 2016

Last Update Submit

December 18, 2025

Conditions

Gastric BypassBlind Loop SyndromeBacterial Overgrowth SyndromeChromatography, Gas

Keywords

Gastric bypassIntestinal Bacterial Overgrowth SyndromeGas chromatography

Outcome Measures

Primary Outcomes (1)

  • Changes in expired hydrogen H2 concentration

    Measured by gas chromatography

    change at baseline et up to 24 months

Secondary Outcomes (3)

  • Changes in digestive symptoms

    change at baseline et up to 24 months

  • Changes in intestinal transit

    change at baseline et up to 24 months

  • Changes in malabsorption

    change at baseline et up to 24 months

Study Arms (1)

Gas chromatography and stool analysis

EXPERIMENTAL

gas chromatography and stool analysis for detection of malabsorption

Procedure: gas chromatographyProcedure: Stool analysis for detection of malabsorption

Interventions

gas chromatographyPROCEDURE
Gas chromatography and stool analysis
Stool analysis for detection of malabsorptionPROCEDURE
Gas chromatography and stool analysis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier d'Arras

Arras, 62022, France

Location

Centre Hospitalier de Douai

Douai, 59507, France

Location

Related Publications (1)

  • 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.

    PMID: 38300481RESULT

MeSH Terms

Conditions

Blind Loop SyndromeMucopolysaccharidosis IV

Interventions

Chromatography, GasOccult Blood

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesMucopolysaccharidosesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLysosomal Storage DiseasesMucinosesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ChromatographyChemistry Techniques, AnalyticalInvestigative TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Vincent Florent, MD, PhD

    Centre Hospitalier Arras

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 30, 2016

Study Start

May 27, 2016

Primary Completion

October 7, 2022

Study Completion

October 7, 2022

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)