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Sarcopenia and Short Bowel Syndrome

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05441345
Acronym
SARCO-SGC
Enrollment
110
Registered
2022-07-01
Start date
2022-08-18
Completion date
2024-07-16
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Bowel Syndrome

Keywords

Sarcopenia, short bowel syndrome, adaptation

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.

Interventions

OTHERquestionnaires 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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evolution of sarcopeniaat 12 monthsChanges in muscle strength (Jamar's dynamometer)

Secondary

MeasureTime frameDescription
Impact of sarcopeniaat 12 monthsChanges in questionnaire of quality of life SarQoL
Link with intestinal adaptationat 12 monthsNumber 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.
Quantification of intestinal adsorption and its link with intestinal adaptationat 12 monthsChanges 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.
Quantification of urinary metabolite linked with sarcopeniaat 12 monthsChanges in urinary markers of fermentation in relation to sarcopenia (metagenomic sequencing)
Quantification of fecal metabolite linked with sarcopeniaat 12 monthsChanges in fecal markers of fermentation in relation to sarcopenia (mass spectrometry)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026