Sarcopenia and Short Bowel Syndrome

NCT ID: NCT05441345

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-18
• Study Completion Date: 2024-07-16

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.

Conditions

Short Bowel Syndrome

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

SBS patients

questionnaires with collection of stool and urine

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie KAPEL, MPharma PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Service de Coprologie Fonctionnelle Hôpital Pitié-Salpêtrière

Paris, , France

Countries

France

Other Identifiers

APHP220496

Identifier Type: -

Identifier Source: org_study_id