NCT03756623

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Metformin powder	0.5g of Metformin powder administered three times a day orally before meal
DRUG	Probiotics powder	0.5g of Probiotics powder administered three times a day orally before meal
OTHER	Placebo powder	0.5g of Placebo powder administered three times a day orally before meal

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-03-31
• Completion: 2019-06-30
• First posted: 2018-11-28
• Last updated: 2019-08-21

Locations

1 site across 1 country: China