Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome
NCT ID: NCT03336840
Last Updated: 2019-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2017-06-01
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metformin
Metformin tablets
0.5g (1 pill) of Metformin tablets administered three times a day orally before meal
Probiotics
ProMetS probiotics powder
4g (2 strips) of ProMetS probiotics powder administered orally every night
Metformin and Probiotics
1. Metformin tablets; 2. ProMetS probiotics powder
1. 0.5g (1 pill) of Metformin tablets administered three times a day orally before meal;
2. 4g (2 strips) of ProMetS probiotics powder administered orally every night
Interventions
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Metformin tablets
0.5g (1 pill) of Metformin tablets administered three times a day orally before meal
ProMetS probiotics powder
4g (2 strips) of ProMetS probiotics powder administered orally every night
1. Metformin tablets; 2. ProMetS probiotics powder
1. 0.5g (1 pill) of Metformin tablets administered three times a day orally before meal;
2. 4g (2 strips) of ProMetS probiotics powder administered orally every night
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria.
Exclusion Criteria
2. Significant impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease.
3. Use of antibiotics within 3 months.
4. Symptoms of any infection at screening.
5. Immunodeficient or use of immunosuppressive drugs.
6. Use of products containing prebiotics or probiotics within the last 3 months.
7. Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
8. Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator
18 Years
40 Years
FEMALE
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Dalong Zhu
Chief Physician
Locations
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Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PCOS2017
Identifier Type: -
Identifier Source: org_study_id
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