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Enrolling by Invitation

NCT Number: NCT03995342

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

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.

Enrolling by Invitation

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inulin

Dietary Supplement

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

Maltodextrin

Dietary Supplement

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

Other names: Placebo

Primary outcomes

  1. Improvement of frailty

    Time frame: 3 months

    Frailty will be diagnosed according to Fried criteria

Secondary outcomes

  1. Diversity analysis of intestinal flora

    Time frame: 3 months

    Change of diversity analysis of intestinal flora

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2019
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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