Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03756623

Enrollment

Registered

2018-11-28

Start date

2018-06-01

Completion date

2019-06-30

Last updated

2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGMetformin powder

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

DRUGProbiotics powder

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

OTHERPlacebo powder

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Gut microbiota alterations	12 weeks	Gut microbiota composition and function will be assessed before and after study.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026