Sarcopenia and Short Bowel Syndrome

Short Bowel Syndrome Clinical Trial

— SARCO-SGC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05441345
• Other study ID #: APHP220496
• Status: Active, not recruiting
• Start date: August 18, 2022
• Est. completion date: August 17, 2024

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: August 17, 2024
• Est. primary completion date: August 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia
• Short Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Service de Coprologie Fonctionnelle Hôpital Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of sarcopenia	Changes in muscle strength (Jamar's dynamometer)	at 12 months
Primary	Evolution of sarcopenia	Changes in muscle mass (bioimpedance analysis)	at 12 months
Secondary	Impact of sarcopenia	Changes in questionnaire of quality of life SarQoL	at 12 months
Secondary	Impact of sarcopenia	Changes in questionnaire of quality of life EQ-5D-3L	at 12 months
Secondary	Impact of sarcopenia	Changes in questionnaire of quality of life SF36	at 12 months
Secondary	Impact of sarcopenia	Changes in questionnaire of physical activity (GPAQ)	at 12 months
Secondary	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
Secondary	Link with intestinal adaptation	Changes in biological markers of adaptation in relation to sarcopenia: ApoB48, citrulline, leptin, nutrients	at 12 months
Secondary	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
Secondary	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
Secondary	Quantification of urinary metabolite linked with sarcopenia	Changes in urinary markers of fermentation in relation to sarcopenia (metagenomic sequencing)	at 12 months
Secondary	Quantification of fecal metabolite linked with sarcopenia	Changes in fecal markers of fermentation in relation to sarcopenia (mass spectrometry)	at 12 months