Back to resultsThe Correlation and Intervention of Intestinal Flora and Frailty in the Elderly
Primary Purpose
Frailty Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Inulin
Maltodextrin
Sponsored by
About this trial
This is an interventional other trial for Frailty Syndrome focused on measuring frailty, flora
Eligibility Criteria
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
Sites / Locations
- Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
exprimental: Inulin
Active comparator: maltodextrin
Arm Description
Inulin 15 grams after dissolution by mouth， every morning for three months.
Placebo (maltodextrin) 15grams after dissolution by mouth， every morning for three months.
Outcomes
Primary Outcome Measures
Improvement of frailty
Frailty will be diagnosed according to Fried criteria
Secondary Outcome Measures
Diversity analysis of intestinal flora
Change of diversity analysis of intestinal flora
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03995342
Brief Title
The Correlation and Intervention of Intestinal Flora and Frailty in the Elderly
Official Title
The Correlation and Intervention of Intestinal Flora and Frailty in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty Syndrome
Keywords
frailty, flora
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exprimental: Inulin
Arm Type
Experimental
Arm Description
Inulin 15 grams after dissolution by mouth， every morning for three months.
Arm Title
Active comparator: maltodextrin
Arm Type
Placebo Comparator
Arm Description
Placebo (maltodextrin) 15grams after dissolution by mouth， every morning for three months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Inulin
Intervention Description
Inulin 15 grams after dissolution by mouth， every morning for three months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Other Intervention Name(s)
Placebo
Intervention Description
Placebo (maltodextrin) 15g/d，Oral administration after dissolution15g/d，Oral administration after dissolution
Primary Outcome Measure Information:
Title
Improvement of frailty
Description
Frailty will be diagnosed according to Fried criteria
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Diversity analysis of intestinal flora
Description
Change of diversity analysis of intestinal flora
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang xiao ming
Organizational Affiliation
Director of geriatrics
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will not make individual participant data (IPD) available to other researchers in a few years.
Learn more about this trial
The Correlation and Intervention of Intestinal Flora and Frailty in the Elderly
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