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

Not Applicable

• Conditions: Frailty Syndrome
• Interventions: Dietary Supplement: Inulin; Dietary Supplement: Maltodextrin

• Registration Number: NCT03995342
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Study Start: 2019-08-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Dementia
• mental illness or blindness
• acute infection
• cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exprimental: Inulin	Inulin	Inulin 15 grams after dissolution by mouth， every morning for three months.
Active comparator: maltodextrin	Maltodextrin	Placebo (maltodextrin) 15grams after dissolution by mouth， every morning for three months.

Primary Outcome Measures

Name	Time	Method
Improvement of frailty	3 months	Frailty will be diagnosed according to Fried criteria

Secondary Outcome Measures

Name	Time	Method
Diversity analysis of intestinal flora	3 months	Change of diversity analysis of intestinal flora

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China