Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756623
• Other study ID #: microbiome2018
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

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