Sarcopenia and Short Bowel Syndrome

Completed

• Conditions: Short Bowel Syndrome
• Interventions: Other: questionnaires with collection of stool and urine

• Registration Number: NCT05441345
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Sarcopenia or the loss of skeletal muscle is highly prevalent in many diseases, including short bowel syndrome (SBS). While adaptation is more likely in SBS patients with a colon-in-continuity, the consequences and underlying mechanisms are unclear. An overabundance of fecal Lactobacillus was found but not yet linked to adaptation or sarcopenia. The objectives are to study the evolution of sarcopenia and the link with intestinal adaptation in SBS.

Detailed Description

Patients with short bowel syndrome (SBS) will be screened and included in longitudinal or cross-sectional studies if eligible.

The longitudinal study will follow patients with type 1 SBS (enterostomy) before and every 3 months after continuity surgery for 1 year. Cross-sectional studies will follow patients with type 2 or 3 SBS (jejunocolonic or -ileal anastomosis) for 1 year (every 3 months during the first 2 years after continuity surgery or every 6 months after).

Study visits will include clinical examination, nutritional assessment, endoscopy with biopsies and/or intestinal absorption assessment planned as part of routine follow-up. In addition, questionnaires will be completed (GPAQ, SarQoL, EQ-5D -3L, SF36), with collection of stool (for routine and research) and urine samples (for research).

The objective are to study the evolution of sarcopenia and the link with intestinal adaptation in SBS. The results may identify metabolic or microbial biomarkers and predictors of nutritional optimisation in SBS, which is a complex and costly orphan disease.

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-07-01
• Study Start: 2022-08-18
• Primary Completion: 2023-08-17
• Study Completion: 2024-07-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Age ≥18 years old
• SBS diagnosis validated by small bowel length and either type 1 (enterostomy), type 2 or 3 (jejuno-colic or -ileal anastomosis)
• Patient not objecting to the collection of personal data as part of the study

Exclusion Criteria

• Pregnancy

  • Remaining hail length unknown
  • Patient expressing opposition to participating in the cohort
  • Patients who are unable to express themselves

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SBS patients	questionnaires with collection of stool and urine	-

Primary Outcome Measures

Name	Time	Method
Evolution of sarcopenia	at 12 months	Changes in muscle mass (bioimpedance analysis)

Secondary Outcome Measures

Name	Time	Method
Link with intestinal adaptation	at 12 months	Changes in bacterial fermentation markers of adaptation in relation to sarcopenia: D-lactate, short-chain fatty acids (SCFAs)
Quantification of fecal metabolite linked with sarcopenia	at 12 months	Changes in fecal markers of fermentation in relation to sarcopenia (mass spectrometry)
Quantification of intestinal adsorption and its link with intestinal adaptation	at 12 months	Changes in intestinal absorption balance markers of adaptation in relation to sarcopenia: digestive losses in fat, proteins, carbohydrates and total energy. These elements will be quantified by biological assessements.
Quantification of urinary metabolite linked with sarcopenia	at 12 months	Changes in urinary markers of fermentation in relation to sarcopenia (metagenomic sequencing)
Impact of sarcopenia	at 12 months	Changes in questionnaire of physical activity (GPAQ)

Trial Locations

Locations (1)

Service de Coprologie Fonctionnelle Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France