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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Frailty Syndrome

Intervention / Treatment
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* Dietary Supplement: Inulin
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exprimental: Inulin<br>Inulin 15 grams after dissolution by mouth， every morning for three months. | Dietary Supplement: Inulin<br>* Inulin 15 grams after dissolution by mouth， every morning for three months.<br>|
| Placebo Comparator: Active comparator: maltodextrin<br>Placebo (maltodextrin) 15grams after dissolution by mouth， every morning for three months. | Dietary Supplement: Maltodextrin<br>* Placebo (maltodextrin) 15g/d，Oral administration after dissolution15g/d，Oral administration after dissolution<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of frailty | Frailty will be diagnosed according to Fried criteria | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diversity analysis of intestinal flora | Change of diversity analysis of intestinal flora | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frailty, flora