Clinical trial NCT05441345: Sarcopenia and Short Bowel Syndrome
Official title: Sarcopenia and Short Bowel Syndrome: the Microbiota-gut-muscle Axis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Bowel Syndrome
Keywords: Sarcopenia
short bowel syndrome
adaptation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Evolution of sarcopenia
timeFrame: at 12 months
measure: Evolution of sarcopenia
timeFrame: at 12 months
Secondary outcomes:
measure: Impact of sarcopenia
timeFrame: at 12 months
measure: Impact of sarcopenia
timeFrame: at 12 months
measure: Impact of sarcopenia
timeFrame: at 12 months
measure: Impact of sarcopenia
timeFrame: at 12 months
measure: Link with intestinal adaptation
timeFrame: at 12 months
measure: Link with intestinal adaptation
timeFrame: at 12 months
measure: Quantification of intestinal adsorption and its link with intestinal adaptation
timeFrame: at 12 months
measure: Link with intestinal adaptation
timeFrame: at 12 months
measure: Quantification of urinary metabolite linked with sarcopenia
timeFrame: at 12 months
measure: Quantification of fecal metabolite linked with sarcopenia
timeFrame: at 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Coprologie Fonctionnelle Hôpital Pitié-Salpêtrière
Study officials:
affiliation: APHP
name: Nathalie KAPEL, MPharma PhD
role: PRINCIPAL_INVESTIGATOR
References: