Back to resultsSmall Intestinal Bacterial Overgrowth Obese (SIBOB)
Primary Purpose
Gastric Bypass, Blind Loop Syndrome, Bacterial Overgrowth Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
gas chromatography
Stool analysis for detection of malabsorption
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Bypass focused on measuring Gastric bypass, Intestinal Bacterial Overgrowth Syndrome, Gas chromatography
Eligibility 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
Sites / Locations
- Centre Hospitalier d'Arras
- Centre Hospitalier de Douai
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gas chromatography and stool analysis
Arm Description
gas chromatography and stool analysis for detection of malabsorption
Outcomes
Primary Outcome Measures
Changes in expired hydrogen H2 concentration
Measured by gas chromatography
Secondary Outcome Measures
Changes in digestive symptoms
Changes in intestinal transit
Characterisation of intestinal transit by measuring stool frequency
Changes in malabsorption
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
Full Information
NCT ID
NCT02819037
First Posted
June 21, 2016
Last Updated
June 21, 2023
Sponsor
Lille Catholic University
Collaborators
Santelys Association
1. Study Identification
Unique Protocol Identification Number
NCT02819037
Brief Title
Small Intestinal Bacterial Overgrowth Obese
Acronym
SIBOB
Official Title
Modification of Digestive Flora After Gastric Bypass : Pilot Study on Microbial Overgrowth Using Gas Chromatography
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 27, 2016 (Actual)
Primary Completion Date
October 7, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University
Collaborators
Santelys Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Bypass, Blind Loop Syndrome, Bacterial Overgrowth Syndrome, Chromatography, Gas
Keywords
Gastric bypass, Intestinal Bacterial Overgrowth Syndrome, Gas chromatography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gas chromatography and stool analysis
Arm Type
Experimental
Arm Description
gas chromatography and stool analysis for detection of malabsorption
Intervention Type
Procedure
Intervention Name(s)
gas chromatography
Intervention Type
Procedure
Intervention Name(s)
Stool analysis for detection of malabsorption
Primary Outcome Measure Information:
Title
Changes in expired hydrogen H2 concentration
Description
Measured by gas chromatography
Time Frame
change at baseline et up to 24 months
Secondary Outcome Measure Information:
Title
Changes in digestive symptoms
Time Frame
change at baseline et up to 24 months
Title
Changes in intestinal transit
Description
Characterisation of intestinal transit by measuring stool frequency
Time Frame
change at baseline et up to 24 months
Title
Changes in malabsorption
Description
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
Time Frame
change at baseline et up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Florent, MD, PhD
Organizational Affiliation
Centre Hospitalier Arras
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier d'Arras
City
Arras
ZIP/Postal Code
62022
Country
France
Facility Name
Centre Hospitalier de Douai
City
Douai
ZIP/Postal Code
59507
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Small Intestinal Bacterial Overgrowth Obese
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