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临床试验/NCT03995342
NCT03995342
Enrolling By Invitation
不适用

The Correlation and Intervention of Intestinal Flora and Frailty in the Elderly

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 300 人2019年8月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Frailty Syndrome
发起方
Xijing Hospital
入组人数
300
试验地点
1
主要终点
Improvement of frailty
状态
Enrolling By Invitation
最后更新
去年

概览

简要总结

The study aim to evaluate the improvement and correlation of soluble dietary fiber (prebiotics) in the frailty of elderly people by a randomized, double-blind, placebo-controlled clinical trial.

详细描述

100 healthy controls, 100 pre-frailty and 100 frailty elderly will be included. the healthy controls will be received no intervention. The pre-frailty will be randomized at a 1:1 ratio to receive prebiotics (inulin) or placebo (maltodextrin) . The degree of improvements and correlation in frailty will be evaluated three months later.Similarly,the frailty also will be randomized at a 1:1 ratio to receive prebiotics (inulin) or placebo (maltodextrin). The degree of improvements and correlation in frailty will be evaluated three months later.

注册库
clinicaltrials.gov
开始日期
2019年8月1日
结束日期
2024年12月31日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Xijing Hospital
责任方
Principal Investigator
主要研究者

Wang Xiaoming-1

Director of geriatrics

Xijing Hospital

入排标准

入选标准

  • Age ≥65 years;
  • Can get up from a chair and walk 6 meters
  • Clearly consciousness, able to read or use words to express and communicate without difficulty
  • Agree and accept the study plan

排除标准

  • Acute and chronic inflammatory disease of the intestine within 3 months
  • Use of antibiotics, probiotics, prebiotics or synthetics, laxatives or diarrhea medications, proton pump inhibitors or gastric motility drugs within 1 month
  • mental illness or blindness
  • acute infection

结局指标

主要结局

Improvement of frailty

时间窗: 3 months

Frailty will be diagnosed according to Fried criteria

次要结局

  • Diversity analysis of intestinal flora(3 months)

研究点 (1)

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