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Small Intestinal Bacterial Overgrowth Obese (SIBOB)

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ClinicalTrials.gov Identifier: NCT02819037
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
Santélys
Information provided by (Responsible Party):
Lille Catholic University

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.

Condition or disease Intervention/treatment Phase
Gastric Bypass Blind Loop Syndrome Bacterial Overgrowth Syndrome Chromatography, Gas Procedure: gas chromatography Procedure: Stool analysis for detection of malabsorption Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Modification of Digestive Flora After Gastric Bypass : Pilot Study on Microbial Overgrowth Using Gas Chromatography
Actual Study Start Date : May 2016
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gas chromatography and stool analysis
gas chromatography and stool analysis for detection of malabsorption
Procedure: gas chromatography
Procedure: Stool analysis for detection of malabsorption



Primary Outcome Measures :
  1. Changes in expired hydrogen H2 concentration [ Time Frame: change at baseline et up to 24 months ]
    Measured by gas chromatography


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819037


Contacts
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Contact: Amélie Lansiaux, MD, PhD 0033320225269 lansiaux.amelie@ghicl.net
Contact: Mélody Plets 0033320225733 plets.melody@ghicl.net

Locations
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France
Centre Hospitalier d'Arras Recruiting
Arras, France, 62022
Contact: Véronique Jankowski    0033321211014 ext +33      
Contact: Secrétariat Unité de Nutrition    0033321211600 ext +33      
Principal Investigator: Vincent Florent         
Sub-Investigator: Séverine Andrieux         
Sub-Investigator: Emmanuel Mulliez         
Centre Hospitalier de Douai Recruiting
Douai, France, 59507
Principal Investigator: Solen Dennetiere         
Sponsors and Collaborators
Lille Catholic University
Santélys
Investigators
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Study Director: Vincent Florent, MD, PhD Centre Hospitalier Arras

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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02819037     History of Changes
Other Study ID Numbers: RC-P0046
2015-A01807-42 ( Other Identifier: ANSM )
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lille Catholic University:
Gastric bypass
Intestinal Bacterial Overgrowth Syndrome
Gas chromatography
Additional relevant MeSH terms:
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Blind Loop Syndrome
Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases