- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07530055
Role of the Microbiota in Intestinal Adaptation During Short Bowel Syndrome (AdMIR)
Role of the Microbiota in Intestinal Adaptation During Short Bowel Syndrome: a Longitudinal Follow-up
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We know that spontaneous adaptation, including weaning from parenteral nutrition, is more likely in patients with short bowel syndrome (SBS) who have the colon in continuity. However, the underlying mechanisms remain unclear. We have shown that the gut microbiota is altered in patients with SBS, with an overabundance of lactic acid bacteria (bacteria responsible for fermentation). It is therefore possible that some of these bacteria may promote spontaneous adaptation and improved absorption in patients with SBS with a colon in continuity, thereby enabling weaning from parenteral nutrition.
In the proposed research, we will study changes in the composition of the gut microbiota in adults with SBS before and at the beginning of the restoration of colonic continuity within the digestive tract (new type 2 SBS patients). To this end, we will compare changes in fecal bacterial populations with the intestine's capacity to adapt and absorb nutrients.
This will make it possible to identify specific factors within the microbiota or in the substances they produce (microbial biomarkers) that could become future targets for improving energy absorption. To address the research question, it is planned to include 15 individuals with SBS, followed in the gastroenterology and nutritional support department at Beaujon Hospital in Clichy
Primary Objective:
To study the relationship between intestinal absorptive capacity in adults with type 2 short bowel syndrome (jejuno-colic anastomosis) and the composition of the fecal microbiota after the restoration of colonic continuity.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Francesca Joly, MD
- Phone Number: +33 1 40 87 53 32
- Email: francisca.joly@aphp.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 years
- Diagnosis of short bowel syndrome with a jejunostomy and a plan to restore jejuno-colic continuity within 3 months
- Remaining post-duodenal small intestine (after the ligament of Treitz) < 200 cm
- Remaining colon > 14%
- Remaining small intestine and colon are healthy (no residual inflammatory, post-radiation, or ischemic disease)
- Patient enrolled in a social security system or entitled to coverage
Exclusion Criteria:
- Pregnancy
- Patient unable to provide consent:
- Due to a disability preventing consent
- Does not understand French
- Patient deprived of liberty, or under legal protection (guardianship or curatorship)
- Participation in another interventional study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patient
|
The only procedures added by the study are the collection of an additional volume of blood and stool/chyme during samples taken as part of routine care, as well as an intestinal biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between intestinal absorptive capacity in adults with type 2 short bowel syndrome after restoration of digestive continuity and changes in the fecal microbiota
Time Frame: from inclusion until 12 months post surgery
|
Analysis of Intestinal Absorptive Function: Absorptive capacity is assessed through a stool analysis measuring macronutrients (NIR spectrometry) and energy (bomb calorimetry) excreted in chyme or stool. This assessment is performed on chyme and stool samples collected over a 48-hour period. Microbiota Analysis: At inclusion, an intestinal chyme sample (from the jejunostomy pouch) and colonic lumen content are collected. Stool samples are also collected for microbiota analysis. |
from inclusion until 12 months post surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Postoperative Complications
- Pathologic Processes
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Malabsorption Syndromes
- Pathological Conditions, Signs and Symptoms
- Short Bowel Syndrome
- Digestive System Physiological Phenomena
- Digestive System and Oral Physiological Phenomena
- Defecation
Other Study ID Numbers
- APHP221024
- IDRCB: 2025-A01399-40 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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