Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Metformin powderDRUG

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

Probiotics powderDRUG

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

Placebo powderOTHER

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Gut microbiota alterations

Gut microbiota composition and function will be assessed before and after study.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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