Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects

Study Overview
=================
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects: a Randomized, Double-blind Study.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Metformin powder
* Drug: Probiotics powder
* Other: Placebo powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 20-60 years of age. Healthy subjects without known diseases. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: Metformin powder<br>0.5g of Metformin powder administered three times a day orally before meal | Drug: Metformin powder<br>* 0.5g of Metformin powder administered three times a day orally before meal<br>|
| Experimental: Drug: Probiotics powder<br>0.5g of Probiotics powder administered three times a day orally before meal | Drug: Probiotics powder<br>* 0.5g of Probiotics powder administered three times a day orally before meal<br>|
| Placebo Comparator: Drug: Placebo powder<br>0.5g of Placebo powder administered three times a day orally before meal | Other: Placebo powder<br>* 0.5g of Placebo powder administered three times a day orally before meal<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota alterations | Gut microbiota composition and function will be assessed before and after study. | 12 weeks |