Gastric BypassSIBOBNCT02819037
Small Intestinal Bacterial Overgrowth Obese
A study testing gas chromatography and Stool analysis for detection of malabsorption in people with Gastric Bypass and Blind Loop Syndrome, run by Lille Catholic University at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastric Bypass, Blind Loop Syndrome, Bacterial Overgrowth Syndrome
- What is being tested?
- gas chromatography and Stool analysis for detection of malabsorption
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesFrance
- Study dates
- 27 May 2016to 7 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier d'Arras
Arras, 62022
Centre Hospitalier de Douai
Douai, 59507
About this study
Official title: Modification of Digestive Flora After Gastric Bypass : Pilot Study on Microbial Overgrowth Using Gas Chromatography
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.
- Being tested
- gas chromatography, Stool analysis for detection of malabsorption
- Keywords
- Gastric bypass, Intestinal Bacterial Overgrowth Syndrome, Gas chromatography
- Medical subject headings
- Blind Loop Syndrome, Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gas chromatographyProcedure or surgery
Stool analysis for detection of malabsorptionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Gas chromatography and stool analysis | Experimental | gas chromatography and stool analysis for detection of malabsorption Receives: Procedure: gas chromatography; Procedure: Stool analysis for detection of malabsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in expired hydrogen H2 concentration
Measured by gas chromatography
Measured: change at baseline et up to 24 months
Secondary outcomes (3)
Changes in digestive symptoms
Measured: change at baseline et up to 24 months
Changes in intestinal transit
Characterisation of intestinal transit by measuring stool frequency
Measured: change at baseline et up to 24 months
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
Measured: change at baseline et up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start27 May 2016
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Santelys Association
- Responsible party
- Sponsor
- Investigators
- Vincent Florent, MD, PhD, Study director, Centre Hospitalier Arras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819037
- Sponsor's protocol ID
- RC-P0046
- Other IDs
- 2015-A01807-42
- Acronym
- SIBOB
- Status last verified
- Dec 2025
- First submitted
- 21 Jun 2016
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Florent V, Dennetiere S, Gaudrat B, Andrieux S, Mulliez E, Norberciak L, Jacquez K. Prospective Monitoring of Small Intestinal Bacterial Overgrowth After Gastric Bypass: Clinical, Biological, and Gas Chromatographic Aspects. Obes Surg. 2024 Mar;34(3):947-958. doi: 10.1007/s11695-024-07080-0. Epub 2024 Feb 1.
PubMed 38300481
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Digestive Flora After Gastric Bypass : Pilot Study on Microbial Overgrowth Using Gas Chromatography
- ClinicalTrials.gov ID
- NCT02819037
- Acronym / sponsor ID
- SIBOB / RC-P0046
- Keywords
- Gastric bypass, Intestinal Bacterial Overgrowth Syndrome, Gas chromatography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Santelys Association
- Study start
- 27 May 2016 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gas chromatography and stool analysis | Experimental | Procedure: gas chromatography, Procedure: Stool analysis for detection of malabsorptiongas chromatography and stool analysis for detection of malabsorption |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gas chromatography | Procedure or surgery | Gas chromatography and stool analysis |
| Stool analysis for detection of malabsorption | Procedure or surgery | Gas chromatography and stool analysis |
Primary outcome
Changes in expired hydrogen H2 concentration
Time frame: change at baseline et up to 24 months
Measured by gas chromatography
3 secondary outcomes
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
Changes in malabsorption
Time frame: change at baseline et up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Results publication: PubMed 38300481Florent V, Dennetiere S, Gaudrat B, Andrieux S, Mulliez E, Norberciak L, Jacquez K. Prospective Monitoring of Small Intestinal Bacterial Overgrowth After Gastric Bypass: Clinical, Biological, and Gas Chromatographic Aspects. Obes Surg. 2024 Mar;34(3):947-958. doi: 10.1007/s11695-024-07080-0. Epub 2024 Feb 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Florent, MD, PhD study director
Centre Hospitalier Arras
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gas chromatography and Stool analysis for detection of malabsorption in people with Gastric Bypass and Blind Loop Syndrome, run by Lille Catholic University at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in expired hydrogen H2 concentration (time frame: change at baseline et up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02819037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.