Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects
1 other identifier
interventional
90
1 country
1
Brief Summary
This clinical trial is designed to evaluate the alteration of gut microbiome in healthy subjects after a 12-week metformin and/or probiotics administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Jun 2018
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 27, 2018
CompletedFirst Posted
Study publicly available on registry
November 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedAugust 21, 2019
August 1, 2019
10 months
November 27, 2018
August 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Gut microbiota alterations
Gut microbiota composition and function will be assessed before and after study.
12 weeks
Study Arms (3)
Drug: Metformin powder
EXPERIMENTAL0.5g of Metformin powder administered three times a day orally before meal
Drug: Probiotics powder
EXPERIMENTAL0.5g of Probiotics powder administered three times a day orally before meal
Drug: Placebo powder
PLACEBO COMPARATOR0.5g of Placebo powder administered three times a day orally before meal
Interventions
0.5g of Metformin powder administered three times a day orally before meal
0.5g of Probiotics powder administered three times a day orally before meal
0.5g of Placebo powder administered three times a day orally before meal
Eligibility Criteria
You may qualify if:
- Between 20-60 years of age.
- Healthy subjects without known diseases.
You may not qualify if:
- During pregnancy and lactation period.
- Impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease.
- Use of metformin/antibiotics within 3 months.
- Immunodeficient or use of immunosuppressive drugs.
- Previous history of gastrointestinal surgery or diseases (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
- Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Study Officials
- PRINCIPAL INVESTIGATOR
Mingming Zhang, MD,PhD
Drum Tower hospital affiliated to Nanjing University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
November 27, 2018
First Posted
November 28, 2018
Study Start
June 1, 2018
Primary Completion
March 31, 2019
Study Completion
June 30, 2019
Last Updated
August 21, 2019
Record last verified: 2019-08