Clinical Trials Directory

Trials / Completed

CompletedNCT05441345

Sarcopenia and Short Bowel Syndrome

Sarcopenia and Short Bowel Syndrome: the Microbiota-gut-muscle Axis

Status
Completed
Phase
Study type
Observational
Enrollment
110 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERquestionnaires with collection of stool and urinequestionnaires will be completed (GPAQ, SarQoL, EQ-5D-3L, SF36), with collection of stool (for care and research) and urine

Timeline

Start date
2022-08-18
Primary completion
2023-08-17
Completion
2024-07-16
First posted
2022-07-01
Last updated
2024-11-19

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05441345. Inclusion in this directory is not an endorsement.