---
title: Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects
nct_id: NCT03756623
overall_status: COMPLETED
phase: NA
sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03756623.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03756623"
ct_last_update_post_date: 2019-08-21
last_seen_at: "2026-05-12T06:57:26.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects

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

**NCT ID:** [NCT03756623](https://clinicaltrials.gov/study/NCT03756623)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- **Conditions:** Healthy
- **Start Date:** 2018-06-01
- **Completion Date:** 2019-06-30
- **CT.gov Last Update:** 2019-08-21

## 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 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.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **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

## Interventions

- **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

- **Gut microbiota alterations** _(time frame: 12 weeks)_ — Gut microbiota composition and function will be assessed before and after study.

## Locations (1)

- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the affiliated nanjing drum tower hospital of nanjing university medical school|nanjing|jiangsu|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03756623*  
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