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

July 15, 2024 updated by: Wang Xiaoming-1, Xijing Hospital
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exprimental: Inulin
Inulin 15 grams after dissolution by mouth， every morning for three months.
Dietary supplement: Inulin
Inulin 15 grams after dissolution by mouth， every morning for three months.
Placebo Comparator: Active comparator: maltodextrin
Placebo (maltodextrin) 15grams after dissolution by mouth， every morning for three months.
Dietary supplement: Maltodextrin
Placebo (maltodextrin) 15g/d，Oral administration after dissolution15g/d，Oral administration after dissolution
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Chair: Wang xiao ming, Director of geriatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20192015-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not make individual participant data (IPD) available to other researchers in a few years.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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