Sarcopenia and Short Bowel Syndrome

NCT05441345 | Completed

• 1 other identifier: APHP220496
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Bowel Syndrome

Keywords

Sarcopenia; short bowel syndrome; adaptation

Outcome Measures

Primary Outcomes (2)

• Evolution of sarcopenia

  Changes in muscle strength (Jamar's dynamometer)

  at 12 months

• Evolution of sarcopenia

  Changes in muscle mass (bioimpedance analysis)

  at 12 months

Secondary Outcomes (10)

• Impact of sarcopenia

  at 12 months

• Impact of sarcopenia

  at 12 months

• Impact of sarcopenia

  at 12 months

• Impact of sarcopenia

  at 12 months

• Link with intestinal adaptation

  at 12 months

Study Arms (1)

SBS patients

Other: questionnaires with collection of stool and urine

Interventions

questionnaires with collection of stool and urine OTHER

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

SBS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients in CMS cared for and followed in the gastroenterology and nutritional assistance department of Beaujon Hospital

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Coprologie Fonctionnelle Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Short Bowel Syndrome; Sarcopenia

Interventions

Surveys and Questionnaires; Urination

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Nathalie KAPEL, MPharma PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: July 1, 2022
• Study Start: August 18, 2022
• Primary Completion: August 17, 2023
• Study Completion: July 16, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)