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Completed

NCT Number: NCT02819037

Small Intestinal Bacterial Overgrowth Obese

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.

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Key information

Conditions

Gastric Bypass Bacterial Overgrowth Syndrome Blind Loop Syndrome Carbohydrate Metabolism, Inborn Errors Chromatography, Gas Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Intestinal Diseases Lysosomal Storage Diseases Malabsorption Syndromes Metabolic Diseases Metabolism, Inborn Errors Mucinoses Mucopolysaccharidoses Mucopolysaccharidosis IV Nutritional and Metabolic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier d'Arras, Arras, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gas chromatography

Procedure

Stool analysis for detection of malabsorption

Procedure

Primary outcomes

  1. Changes in expired hydrogen H2 concentration

    Time frame: change at baseline et up to 24 months

    Measured by gas chromatography

Secondary outcomes

  1. Changes in digestive symptoms

    Time frame: change at baseline et up to 24 months

  2. Changes in intestinal transit

    Time frame: change at baseline et up to 24 months

    Characterisation of intestinal transit by measuring stool frequency

  3. 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

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • Santelys Association

Registry information

Official study title

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

Acronym: SIBOB

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2016
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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