NCT03336840

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

November 2, 2017

Last Update Submit

January 31, 2019

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Improvement in acne score

    Visual assessment of acne using "mild/moderate/severe" grades will be assessed before and after study.

    12 weeks

Secondary Outcomes (10)

  • Gut microbiota

    12 weeks

  • Fasting glucose levels

    12 weeks

  • Fasting insulin levels

    12 weeks

  • Serum follicle-stimulating hormone levels

    12 weeks

  • Serum luteinizing hormone levels

    12 weeks

  • +5 more secondary outcomes

Study Arms (3)

Metformin

EXPERIMENTAL
Drug: Metformin tablets

Probiotics

EXPERIMENTAL
Drug: ProMetS probiotics powder

Metformin and Probiotics

EXPERIMENTAL
Drug: 1. Metformin tablets; 2. ProMetS probiotics powder

Interventions

Metformin tabletsDRUG

0.5g (1 pill) of Metformin tablets administered three times a day orally before meal

Metformin
ProMetS probiotics powderDRUG

4g (2 strips) of ProMetS probiotics powder administered orally every night

Probiotics
1. Metformin tablets; 2. ProMetS probiotics powderDRUG

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

Metformin and Probiotics

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal between 18-40 years of age.
  • Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Dalong Zhu, MD, PhD

CONTACT

86-25-83-105302zhudldr@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 8, 2017

Study Start

June 1, 2017

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

CN(1)