Status:

COMPLETED

Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects

Lead Sponsor:

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Conditions:

Healthy

Eligibility:

All Genders

20-60 years

Phase:

NA

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 inve...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

June 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2019

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT03756623

Start Date

June 1 2018

End Date

June 30 2019

Last Update

August 21 2019

Active Locations (1)

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China, 210008