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Small Intestinal Bacterial Overgrowth Obese

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02819037
Acronym
SIBOB
Enrollment
51
Registered
2016-06-30
Start date
2016-05-27
Completion date
2022-10-07
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Gastric bypass, Intestinal Bacterial Overgrowth Syndrome, Gas chromatography

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.

Interventions

PROCEDUREStool analysis for detection of malabsorption

Sponsors

Santelys Association
CollaboratorOTHER
Lille Catholic University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in expired hydrogen H2 concentrationchange at baseline et up to 24 monthsMeasured by gas chromatography

Secondary

MeasureTime frameDescription
Changes in digestive symptomschange at baseline et up to 24 months
Changes in intestinal transitchange at baseline et up to 24 monthsCharacterisation of intestinal transit by measuring stool frequency
Changes in malabsorptionchange at baseline et up to 24 monthsDetection 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026