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Trial record 99 of 448 for:    diphenhydramine

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

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ClinicalTrials.gov Identifier: NCT03336840
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin tablets Drug: ProMetS probiotics powder Drug: 1. Metformin tablets; 2. ProMetS probiotics powder Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome: a Randomized, Parallel Study
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metformin Drug: Metformin tablets
0.5g (1 pill) of Metformin tablets administered three times a day orally before meal

Experimental: Probiotics Drug: ProMetS probiotics powder
4g (2 strips) of ProMetS probiotics powder administered orally every night

Experimental: Metformin and Probiotics 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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Improvement in acne score [ Time Frame: 12 weeks ]
    Visual assessment of acne using "mild/moderate/severe" grades will be assessed before and after study.


Secondary Outcome Measures :
  1. Gut microbiota [ Time Frame: 12 weeks ]
  2. Fasting glucose levels [ Time Frame: 12 weeks ]
  3. Fasting insulin levels [ Time Frame: 12 weeks ]
  4. Serum follicle-stimulating hormone levels [ Time Frame: 12 weeks ]
  5. Serum luteinizing hormone levels [ Time Frame: 12 weeks ]
  6. Serum estradiol levels [ Time Frame: 12 weeks ]
  7. Serum testosterone levels [ Time Frame: 12 weeks ]
  8. Serum lipid profiles [ Time Frame: 12 weeks ]
    including triglycerides (mmol/L), total cholesterol (mmol/L), low density lipoprotein cholesterol (mmol/L), and high density lipoprotein cholesterol (mmol/L)

  9. Inflammation markers [ Time Frame: 12 weeks ]
    including C-reactive protein (mg/L)

  10. Immune cells [ Time Frame: 12 weeks ]
    including count and frequency of T-cell subpopulations like T-regulatory (Treg) cells (/ml), T-helper (Th) cells (/ml)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336840


Contacts
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Contact: Dalong Zhu, MD, PhD 86-25-83-105302 zhudldr@gmail.com

Locations
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China, Jiangsu
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Dalong Zhu, MD,PhD    86-25-83-105302    zhudldr@gmail.com   
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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Responsible Party: Dalong Zhu, Chief Physician, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT03336840     History of Changes
Other Study ID Numbers: PCOS2017
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Promethazine
Diphenhydramine
Sleep Aids, Pharmaceutical
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics