Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-06-30

Brief Summary

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This clinical trial is designed to evaluate the alteration of gut microbiome in healthy subjects after a 12-week metformin and/or probiotics administration.

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Detailed Description

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Gut microbiome dysbiosis have been linked with the onset and progression of several diseases. Metformin and probiotics have been confirmed to function partly by regulating the gut microbiome. The investigators are now wondering if metformin/probiotics treatment will change the gut microbiota in healthy subjects and show some benefits.

In this study, about 60 healthy subjects will be enrolled. Participants will be randomly assigned into one of the following three groups: Metformin powder (0.5g tid po), Probiotics powder (0.5g tid po), Placebo powder (0.5g tid po), for 12 weeks.

Blood and stool samples will be collected before and after treatment. Fasting glucose levels, fasting insulin levels, serum lipid profiles, inflammation markers and alteration of gut microbiota will be evaluated.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Drug: Metformin powder

0.5g of Metformin powder administered three times a day orally before meal

Group Type EXPERIMENTAL

Metformin powder

Intervention Type DRUG

0.5g of Metformin powder administered three times a day orally before meal

Drug: Probiotics powder

0.5g of Probiotics powder administered three times a day orally before meal

Group Type EXPERIMENTAL

Probiotics powder

Intervention Type DRUG

0.5g of Probiotics powder administered three times a day orally before meal

Drug: Placebo powder

0.5g of Placebo powder administered three times a day orally before meal

Group Type PLACEBO_COMPARATOR

Placebo powder

Intervention Type OTHER

0.5g of Placebo powder administered three times a day orally before meal

Interventions

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Metformin powder

0.5g of Metformin powder administered three times a day orally before meal

Intervention Type DRUG

Probiotics powder

0.5g of Probiotics powder administered three times a day orally before meal

Intervention Type DRUG

Placebo powder

0.5g of Placebo powder administered three times a day orally before meal

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Between 20-60 years of age.
2. Healthy subjects without known diseases.

Exclusion Criteria

1. During pregnancy and lactation period.
2. Impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease.
3. Use of metformin/antibiotics within 3 months.
4. Immunodeficient or use of immunosuppressive drugs.
5. Previous history of gastrointestinal surgery or diseases (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
6. Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes