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

Xijing Hospital300 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

300

Conditions

Frailty Syndrome

Interventions

InulinDIETARY_SUPPLEMENT

Inulin 15 grams after dissolution by mouth， every morning for three months.

MaltodextrinDIETARY_SUPPLEMENT

Placebo (maltodextrin) 15g/d，Oral administration after dissolution15g/d，Oral administration after dissolution

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Xijing Hospital

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

Improvement of frailty

Frailty will be diagnosed according to Fried criteria

Time frame: 3 months

Secondary Outcomes

Diversity analysis of intestinal flora

Change of diversity analysis of intestinal flora

Time frame: 3 months

Data from ClinicalTrials.gov

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