Role of the Microbiota in Intestinal Adaptation During Short Bowel Syndrome

NCT07530055 | Not Yet Recruiting

• 2 other identifiers: APHP221024IDRCB: 2025-A01399-40
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Short Bowel Syndrome (SBS)

Keywords

Short Bowel Syndrome; Intestinal Adaptation; Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (1)

• Correlation between intestinal absorptive capacity in adults with type 2 short bowel syndrome after restoration of digestive continuity and changes in the fecal microbiota

  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

Study Arms (1)

Patient

OTHER

Other: collection of blood and stool/chyme and intestinal biopsy

Interventions

collection of blood and stool/chyme and intestinal biopsy OTHER

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

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

Defecation

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Francesca Joly, MD

CONTACT

+33 1 40 87 53 32; francisca.joly@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04