Sarcopenia and Short Bowel Syndrome (SARCO-SGC)

A

Assistance Publique - Hôpitaux de Paris

Status

Active, not recruiting

Conditions

Short Bowel Syndrome

Treatments

Other: questionnaires with collection of stool and urine

Study type

Observational

Funder types

Other

Identifiers

NCT05441345
APHP220496

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

110 participants in 1 patient group

SBS patients
Treatment:
Other: questionnaires with collection of stool and urine

Trial contacts and locations

1

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Central trial contact

Frasisca JOLY, MD PhD; Nathalie KAPEL, MPharma PhD

Data sourced from clinicaltrials.gov

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