ClinicalTrials.gg
CompletedNCT02819037SIBOBUpdated Dec 24, 2025

Small Intestinal Bacterial Overgrowth Obese

An interventional study of gas chromatography and Stool analysis for detection of malabsorption in Gastric Bypass, Blind Loop Syndrome and Bacterial Overgrowth Syndrome, sponsored by Lille Catholic University. Completed at 2 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Lille Catholic University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Bypass
  • Blind Loop Syndrome
  • Bacterial Overgrowth Syndrome
  • Chromatography, Gas

Keywords

  • Gastric bypass
  • Intestinal Bacterial Overgrowth Syndrome
  • Gas chromatography
03

In context

Blind Loop Syndrome

11 studies on the registry are indexed under Blind Loop Syndrome; 4 are open to participants now.

This study's enrollment of 51 is close to the median of 48 across 10 interventional studies indexed under Blind Loop Syndrome.

Browse Blind Loop Syndrome studies →

Lead sponsor

Lille Catholic University is the lead sponsor of 112 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Severe obesity (>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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • 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

Interventions

  • Proceduregas chromatography
  • ProcedureStool analysis for detection of malabsorption
06

What researchers measure

Primary outcomes

  1. Changes in expired hydrogen H2 concentration

    Measured by gas chromatography

    Time frame: change at baseline et up to 24 months

Secondary outcomes

  1. Changes in digestive symptoms

    Time frame: change at baseline et up to 24 months

  2. Changes in intestinal transit

    Characterisation of intestinal transit by measuring stool frequency

    Time frame: change at baseline et up to 24 months

  3. 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

    Time frame: change at baseline et up to 24 months

07

Study locations

2 sites
  • Centre Hospitalier d'Arras
    Arras, 62022, France
  • Centre Hospitalier de Douai
    Douai, 59507, France
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2016 to primary completion in Oct 2022, 76 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2016
First posted
Jun 30, 2016
StartActual
May 27, 2016
Primary completionActual
Oct 7, 2022
CompletionActual
Oct 7, 2022
Last update
Dec 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02819037
Collaborators
Santelys Association
Responsible party
Sponsor
First posted
Jun 30, 2016
Start date
May 27, 2016
Primary completion
Oct 7, 2022
Completion
Oct 7, 2022
Last update
Dec 24, 2025

Study contacts

Vincent Florent, MD, PhD
study director · Centre Hospitalier Arras

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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