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
| Type | Name | Description |
|---|---|---|
| OTHER | questionnaires with collection of stool and urine | questionnaires 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.