跳至主要内容
临床试验/NCT05441345
NCT05441345已完成不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Evolution of sarcopenia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Pregnancy
  • Remaining hail length unknown
  • Patient expressing opposition to participating in the cohort
  • Patients who are unable to express themselves

结局指标

主要结局

Evolution of sarcopenia

时间窗: at 12 months

Changes in muscle mass (bioimpedance analysis)

次要结局

  • Link with intestinal adaptation(at 12 months)
  • Quantification of fecal metabolite linked with sarcopenia(at 12 months)
  • Quantification of intestinal adsorption and its link with intestinal adaptation(at 12 months)
  • Quantification of urinary metabolite linked with sarcopenia(at 12 months)
  • Impact of sarcopenia(at 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验