Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome: a Randomized, Parallel Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03336840
• Other study ID #: PCOS2017
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: June 2019

Study information

• Verified date: January 2019
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Dalong Zhu, MD, PhD
• Phone: 86-25-83-105302
• Email: zhudldr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Premenopausal between 18-40 years of age.

2. Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria.

Exclusion Criteria:

1. During the pregnancy and lactation period.

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• 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
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

Locations

Country	Name	City	State
China	Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	Improvement in acne score	Visual assessment of acne using "mild/moderate/severe" grades will be assessed before and after study.	12 weeks
Secondary	Gut microbiota		12 weeks
Secondary	Fasting glucose levels		12 weeks
Secondary	Fasting insulin levels		12 weeks
Secondary	Serum follicle-stimulating hormone levels		12 weeks
Secondary	Serum luteinizing hormone levels		12 weeks
Secondary	Serum estradiol levels		12 weeks
Secondary	Serum testosterone levels		12 weeks
Secondary	Serum lipid profiles	including triglycerides (mmol/L), total cholesterol (mmol/L), low density lipoprotein cholesterol (mmol/L), and high density lipoprotein cholesterol (mmol/L)	12 weeks
Secondary	Inflammation markers	including C-reactive protein (mg/L)	12 weeks
Secondary	Immune cells	including count and frequency of T-cell subpopulations like T-regulatory (Treg) cells (/ml), T-helper (Th) cells (/ml)	12 weeks