Polycystic Ovary SyndromeNCT03336840
Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome
A study testing Metformin tablets, ProMetS probiotics powder and 1. Metformin tablets; 2. ProMetS probiotics powder in people with Polycystic Ovary Syndrome, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin tablets, ProMetS probiotics powder and 1. Metformin tablets; 2. ProMetS probiotics powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal between 18-40 years of age.
- Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008
Dalong Zhu, MD,PhD, 86-25-83-105302, zhudldr@gmail.com
About this study
Official title: Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome: a Randomized, Parallel Study
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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin tablets, ProMetS probiotics powder, 1. Metformin tablets; 2. ProMetS probiotics powder
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin tabletsDrug
0.5g (1 pill) of Metformin tablets administered three times a day orally before meal
ProMetS probiotics powderDrug
4g (2 strips) of ProMetS probiotics powder administered orally every night
1. Metformin tablets; 2. ProMetS probiotics powderDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Not described Receives: Drug: Metformin tablets |
| Probiotics | Experimental | Not described Receives: Drug: ProMetS probiotics powder |
| Metformin and Probiotics | Experimental | Not described Receives: Drug: 1. Metformin tablets; 2. ProMetS probiotics powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Improvement in acne score
Visual assessment of acne using "mild/moderate/severe" grades will be assessed before and after study.
Measured: 12 weeks
Secondary outcomes (10)
Gut microbiota
Measured: 12 weeks
Fasting glucose levels
Measured: 12 weeks
Fasting insulin levels
Measured: 12 weeks
Serum follicle-stimulating hormone levels
Measured: 12 weeks
Serum luteinizing hormone levels
Measured: 12 weeks
Serum estradiol levels
Measured: 12 weeks
Serum testosterone levels
Measured: 12 weeks
Serum lipid profiles
including triglycerides (mmol/L), total cholesterol (mmol/L), low density lipoprotein cholesterol (mmol/L), and high density lipoprotein cholesterol (mmol/L)
Measured: 12 weeks
Inflammation markers
including C-reactive protein (mg/L)
Measured: 12 weeks
Immune cells
including count and frequency of T-cell subpopulations like T-regulatory (Treg) cells (/ml), T-helper (Th) cells (/ml)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Jun 2017
- Primary completionMar 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336840
- Sponsor's protocol ID
- PCOS2017
- Status last verified
- Jan 2019
- First submitted
- 2 Nov 2017
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome: a Randomized, Parallel Study
- ClinicalTrials.gov ID
- NCT03336840
- Acronym / sponsor ID
- PCOS2017
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin tablets |
| Probiotics | Experimental | Drug: ProMetS probiotics powder |
| Metformin and Probiotics | Experimental | Drug: 1. Metformin tablets; 2. ProMetS probiotics powder |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Premenopausal between 18-40 years of age.
- Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin tablets0.5g (1 pill) of Metformin tablets administered three times a day orally before meal | Drug | Metformin |
| ProMetS probiotics powder4g (2 strips) of ProMetS probiotics powder administered orally every night | Drug | Probiotics |
| 1. Metformin tablets; 2. ProMetS probiotics powder1. 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 | Drug | Metformin and Probiotics |
Primary outcome
Improvement in menstrual cycle
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
Visual assessment of acne using "mild/moderate/severe" grades will be assessed before and after study.
10 secondary outcomes
Gut microbiota
Time frame: 12 weeks
Fasting glucose levels
Time frame: 12 weeks
Fasting insulin levels
Time frame: 12 weeks
Serum follicle-stimulating hormone levels
Time frame: 12 weeks
Serum luteinizing hormone levels
Time frame: 12 weeks
Serum estradiol levels
Time frame: 12 weeks
Serum testosterone levels
Time frame: 12 weeks
Serum lipid profiles
Time frame: 12 weeks
Inflammation markers
Time frame: 12 weeks
Immune cells
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin tablets, ProMetS probiotics powder and 1. Metformin tablets; 2. ProMetS probiotics powder in people with Polycystic Ovary Syndrome, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalong Zhu, MD, PhD (86-25-83-105302, zhudldr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in menstrual cycle (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.