Back to resultsEffect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Metformin tablets
ProMetS probiotics powder
1. Metformin tablets; 2. ProMetS probiotics powder
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria:
- Premenopausal between 18-40 years of age.
- Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria.
Exclusion Criteria:
- During the pregnancy and lactation period.
- Significant impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease.
- Use of antibiotics within 3 months.
- Symptoms of any infection at screening.
- Immunodeficient or use of immunosuppressive drugs.
- Use of products containing prebiotics or probiotics within the last 3 months.
- Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
- Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator
Sites / Locations
- Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Metformin
Probiotics
Metformin and Probiotics
Arm Description
Outcomes
Primary Outcome Measures
Improvement in menstrual cycle
Patients will be required to maintain a menstrual calendar and record their basal body temperature for the duration of the study and asked to fill a questionnaire before and after study. The questionnaire will cover menstrual cycle dates, duration and amount.
Improvement in hirsutism
Modified Ferriman and Gallwey score (m-FG scores) will be measured before and after study. M-FG score > 8 is considered hirsutism and when the score is higher, the symptom is more serious.
Improvement in acne score
Visual assessment of acne using "mild/moderate/severe" grades will be assessed before and after study.
Secondary Outcome Measures
Gut microbiota
Fasting glucose levels
Fasting insulin levels
Serum follicle-stimulating hormone levels
Serum luteinizing hormone levels
Serum estradiol levels
Serum testosterone levels
Serum lipid profiles
including triglycerides (mmol/L), total cholesterol (mmol/L), low density lipoprotein cholesterol (mmol/L), and high density lipoprotein cholesterol (mmol/L)
Inflammation markers
including C-reactive protein (mg/L)
Immune cells
including count and frequency of T-cell subpopulations like T-regulatory (Treg) cells (/ml), T-helper (Th) cells (/ml)
Full Information
NCT ID
NCT03336840
First Posted
November 2, 2017
Last Updated
January 31, 2019
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1. Study Identification
Unique Protocol Identification Number
NCT03336840
Brief Title
Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome
Official Title
Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome: a Randomized, Parallel Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness on the clinical and biological parameters of reproductive-aged PCOS women after a 12-week metformin and/or probiotics administration.
Detailed Description
Probiotics are live bacteria that offer a health benefit to the host when administered in adequate amounts. Probiotic supplementation is safe for use and has demonstrated beneficial effects for metabolic diseases such as obesity and diabetes. In this study, about 90 reproductive-aged women with PCOS will be enrolled. Participants will be randomly assigned into one of the following three groups: Metformin tablets (0.5g tid po), ProMetS probiotics powder (4g qN po), Metformin tablets (0.5g tid po) and ProMetS probiotics powder (4g qN po), for 12 weeks. Blood and stool samples will be collected before and after treatment. Fasting glucose levels, fasting insulin levels, sex hormone levels, serum lipid profiles, inflammation markers, other metabolic related parameters and change of gut microbiota and immune cells will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Experimental
Arm Title
Probiotics
Arm Type
Experimental
Arm Title
Metformin and Probiotics
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metformin tablets
Intervention Description
0.5g (1 pill) of Metformin tablets administered three times a day orally before meal
Intervention Type
Drug
Intervention Name(s)
ProMetS probiotics powder
Intervention Description
4g (2 strips) of ProMetS probiotics powder administered orally every night
Intervention Type
Drug
Intervention Name(s)
1. Metformin tablets; 2. ProMetS probiotics powder
Intervention Description
0.5g (1 pill) of Metformin tablets administered three times a day orally before meal;
4g (2 strips) of ProMetS probiotics powder administered orally every night
Primary Outcome Measure Information:
Title
Improvement in menstrual cycle
Description
Patients will be required to maintain a menstrual calendar and record their basal body temperature for the duration of the study and asked to fill a questionnaire before and after study. The questionnaire will cover menstrual cycle dates, duration and amount.
Time Frame
12 weeks
Title
Improvement in hirsutism
Description
Modified Ferriman and Gallwey score (m-FG scores) will be measured before and after study. M-FG score > 8 is considered hirsutism and when the score is higher, the symptom is more serious.
Time Frame
12 weeks
Title
Improvement in acne score
Description
Visual assessment of acne using "mild/moderate/severe" grades will be assessed before and after study.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Gut microbiota
Time Frame
12 weeks
Title
Fasting glucose levels
Time Frame
12 weeks
Title
Fasting insulin levels
Time Frame
12 weeks
Title
Serum follicle-stimulating hormone levels
Time Frame
12 weeks
Title
Serum luteinizing hormone levels
Time Frame
12 weeks
Title
Serum estradiol levels
Time Frame
12 weeks
Title
Serum testosterone levels
Time Frame
12 weeks
Title
Serum lipid profiles
Description
including triglycerides (mmol/L), total cholesterol (mmol/L), low density lipoprotein cholesterol (mmol/L), and high density lipoprotein cholesterol (mmol/L)
Time Frame
12 weeks
Title
Inflammation markers
Description
including C-reactive protein (mg/L)
Time Frame
12 weeks
Title
Immune cells
Description
including count and frequency of T-cell subpopulations like T-regulatory (Treg) cells (/ml), T-helper (Th) cells (/ml)
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal between 18-40 years of age.
Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria.
Exclusion Criteria:
During the pregnancy and lactation period.
Significant impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease.
Use of antibiotics within 3 months.
Symptoms of any infection at screening.
Immunodeficient or use of immunosuppressive drugs.
Use of products containing prebiotics or probiotics within the last 3 months.
Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dalong Zhu, MD, PhD
Phone
86-25-83-105302
Email
zhudldr@gmail.com
Facility Information:
Facility Name
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalong Zhu, MD,PhD
Phone
86-25-83-105302
Email
zhudldr@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome
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