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

During the first years following intestinal resection, spontaneous physiological adaptations occur in patients with short bowel syndrome (SBS), allowing improvement of the absorptive capacity of the remaining intestine. This adaptation is particularly effective in SBS patients with the colon in continuity. The specific relationship between this intestinal adaptation and changes in the gut microbiota has not been studied in these patients. We hypothesize that there is a specific relationship between the microbiota and its metabolites and intestinal adaptive capacity, and that certain gut bacteria may promote this spontaneous adaptation.

Study Overview

Status

Not yet recruiting

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

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Short Bowel Syndrome (SBS)

Clinical Trials on collection of blood and stool/chyme and intestinal biopsy

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