Sarcopenia and Short Bowel Syndrome (SARCO-SGC)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Other: questionnaires with collection of stool and urine

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.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

• Study Contact: Name: Nathalie KAPEL, MPharma PhD; Phone Number: +33 1 42 16 26 56; Email: nathalie.kapel@aphp.fr
• Study Contact Backup: Name: Frasisca JOLY, MD PhD; Phone Number: +33 1 40 87 53 32; Email: francisca.joly@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Service de Coprologie Fonctionnelle Hôpital Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SBS patients	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of sarcopenia	Changes in questionnaire of quality of life SarQoL	at 12 months
Impact of sarcopenia	Changes in questionnaire of quality of life EQ-5D-3L	at 12 months
Impact of sarcopenia	Changes in questionnaire of quality of life SF36	at 12 months
Impact of sarcopenia	Changes in questionnaire of physical activity (GPAQ)	at 12 months
Link with intestinal adaptation	Number of changes in histological markers of adaptation in relation to sarcopenia. Each of these elements can be considered as a chang : crypt depths, villi length, immune cells.	at 12 months
Link with intestinal adaptation	Changes in biological markers of adaptation in relation to sarcopenia: ApoB48, citrulline, leptin, nutrients	at 12 months
Quantification of intestinal adsorption and its link with intestinal adaptation	Changes in intestinal absorption balance markers of adaptation in relation to sarcopenia: digestive losses in fat, proteins, carbohydrates and total energy. These elements will be quantified by biological assessements.	at 12 months
Link with intestinal adaptation	Changes in bacterial fermentation markers of adaptation in relation to sarcopenia: D-lactate, short-chain fatty acids (SCFAs)	at 12 months
Quantification of urinary metabolite linked with sarcopenia	Changes in urinary markers of fermentation in relation to sarcopenia (metagenomic sequencing)	at 12 months
Quantification of fecal metabolite linked with sarcopenia	Changes in fecal markers of fermentation in relation to sarcopenia (mass spectrometry)	at 12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Nathalie KAPEL, MPharma PhD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Actual): August 17, 2023
• Study Completion (Estimated): August 17, 2024

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Sarcopenia; short bowel syndrome; adaptation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Disease; Gastrointestinal Diseases; Intestinal Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Malabsorption Syndromes; Muscular Atrophy; Atrophy; Syndrome; Sarcopenia; Short Bowel Syndrome
• Other Study ID Numbers: APHP220496

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No