NCT03336840

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Metformin tablets	0.5g (1 pill) of Metformin tablets administered three times a day orally before meal
DRUG	ProMetS probiotics powder	4g (2 strips) of ProMetS probiotics powder administered orally every night
DRUG	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

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-03-01
• Completion: 2019-06-01
• First posted: 2017-11-08
• Last updated: 2019-02-01

Locations

1 site across 1 country: China