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Completed

NCT Number: NCT03756623

Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects

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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Key information

Conditions

Healthy

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metformin powder

Drug

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

Probiotics powder

Drug

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

Placebo Powder

Other

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

Primary outcomes

  1. Gut microbiota alterations

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2018
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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