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This clinical trial is designed to evaluate the alteration of gut microbiome in healthy subjects after a 12-week metformin and/or probiotics administration.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Metformin powder | Experimental | 0.5g of Metformin powder administered three times a day orally before meal |
|
| Drug: Probiotics powder | Experimental | 0.5g of Probiotics powder administered three times a day orally before meal |
|
| Drug: Placebo powder | Placebo Comparator | 0.5g of Placebo powder administered three times a day orally before meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin powder | Drug | 0.5g of Metformin powder administered three times a day orally before meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota alterations | Gut microbiota composition and function will be assessed before and after study. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mingming Zhang, MD,PhD | Drum Tower hospital affiliated to Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
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| 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 |
|