Clinical Trial: Small Intestinal Bacterial Overgrowth Obese

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Modification of Digestive Flora After Gastric Bypass : Pilot Study on Microbial Overgrowth Using 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.

Detailed Summary:
Sponsor: Lille Catholic University

Current Primary Outcome: Changes in expired hydrogen H2 concentration [ Time Frame: change at baseline et up to 24 months ]

Measured by gas chromatography


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in digestive symptoms [ Time Frame: 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
  • 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


Original Secondary Outcome: Same as current

Information By: Lille Catholic University

Dates:
Date Received: June 21, 2016
Date Started: May 2016
Date Completion: November 2020
Last Updated: August 2, 2016
Last Verified: June 2016