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

Frailty Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03995342
• Other study ID #: KY20192015-F-1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2020
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome

Intervention

Dietary Supplement:
• Inulin
Inulin 15 grams after dissolution by mouth, every morning for three months.
• Maltodextrin
Placebo (maltodextrin) 15g/d,Oral administration after dissolution15g/d,Oral administration after dissolution

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of frailty	Frailty will be diagnosed according to Fried criteria	3 months
Secondary	Diversity analysis of intestinal flora	Change of diversity analysis of intestinal flora	3 months