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OpenTrials
Completed

NCT Number: NCT05441345

Sarcopenia and Short Bowel Syndrome

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Coprologie Fonctionnelle Hôpital Pitié-Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Evolution of sarcopenia

    Time frame: at 12 months

    Changes in muscle strength (Jamar's dynamometer)

  2. Evolution of sarcopenia

    Time frame: at 12 months

    Changes in muscle mass (bioimpedance analysis)

Secondary outcomes

  1. Impact of sarcopenia

    Time frame: at 12 months

    Changes in questionnaire of quality of life SarQoL

  2. Impact of sarcopenia

    Time frame: at 12 months

    Changes in questionnaire of quality of life EQ-5D-3L

  3. Impact of sarcopenia

    Time frame: at 12 months

    Changes in questionnaire of quality of life SF36

  4. Impact of sarcopenia

    Time frame: at 12 months

    Changes in questionnaire of physical activity (GPAQ)

  5. Link with intestinal adaptation

    Time frame: at 12 months

    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.

  6. Link with intestinal adaptation

    Time frame: at 12 months

    Changes in biological markers of adaptation in relation to sarcopenia: ApoB48, citrulline, leptin, nutrients

  7. Quantification of intestinal adsorption and its link with intestinal adaptation

    Time frame: at 12 months

    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.

  8. Link with intestinal adaptation

    Time frame: at 12 months

    Changes in bacterial fermentation markers of adaptation in relation to sarcopenia: D-lactate, short-chain fatty acids (SCFAs)

  9. Quantification of urinary metabolite linked with sarcopenia

    Time frame: at 12 months

    Changes in urinary markers of fermentation in relation to sarcopenia (metagenomic sequencing)

  10. Quantification of fecal metabolite linked with sarcopenia

    Time frame: at 12 months

    Changes in fecal markers of fermentation in relation to sarcopenia (mass spectrometry)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: SARCO-SGC

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 1, 2022
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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