Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Probiotics, Metformin & Their Combination Therapy in the Treatment of PCOS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04009603
Recruitment Status : Completed
First Posted : July 5, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Urooj Zafar, Ziauddin University

Brief Summary:
Polycystic ovary syndrome (PCOS) is a common gynecological state worldwide characterized by numerous small cysts in the ovaries mainly due to the imbalance of endocrine hormones in premenopausal women. Metformin is long being used for different symptoms of PCOS along with other medication. This study involves the assessment of different parameters of PCOS.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Probiotic Agent Drug: Metformin Not Applicable

Detailed Description:

Polycystic ovary syndrome (PCOS) is a hormonal disorder affecting the women of reproductive age. It is a heterogeneous health condition that affects 1 in every 10 women of childbearing age. Women of all races and ethnicities are at risk for PCOS, but risk increases multiple folds if the BMI is greater than 30kg/m2. The common signs and symptoms, the women usually represent with are menstrual irregularities, hyperandrogenemia and multiple cysts in ovaries. The exact cause of PCOS is still unknown but genetic and obesity is considered to be the most common cause.

Metformin has been considered as the first line agent for the treatment of non-insulin dependent diabetes mellitus and up till now it has been used as a first line drug for PCOS. Despite its beneficial effects in PCOS it has several adverse effects. Moreover, patients usually seek two or more drugs along with metformin to relieve maximum symptoms of PCOS like for ovulation clomiphene citrate must be given etc. So there is a need of novel and comprehensive agent that can prove to be effective in improving maximum symptoms of this disease. Probiotics have received renewed attention in the 21st century through research studies. World Health Organization's (WHO) 2001 defines probiotics as live micro-organisms that, when administered in adequate amounts, confer a health benefit on the host. In recent year it has shown tremendous promising effect in treatment of different diseases like diarrhea, gingivitis and obesity etc with negligible side effects.

In this context the investigators are going to evaluate and compare the effects of probiotics, metformin and their combination therapy in treatment of various symptoms of PCOS.60 newly diagnosed PCOS patient will be assigned in the open label randomized clinical trial. As mentioned above patients will be divided into three groups with 20 patients each. In group 1, the dosage of metformin will be 500mg B.D and 2 gm of probiotic sachet O.D, the second group will be given metformin 500mg B.D. and the third group will be 2mg of probiotics B.D. It would be a follow-up study that would be conducted in Gynecology OPD of Tertiary Care Hospital

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Probiotics, Metformin and Their Combination Therapy in Improving Symptoms of Polycystic Ovarian Syndrome.̎- A Randomized Clinical Trial
Actual Study Start Date : December 6, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : January 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Metformin
Group no 1(26 patients) Metformin tablets at a dose of 500mg BD for 12 weeks
Drug: Metformin

Metformin, an insulin sensitizer, is an oral biguanide that is most commonly prescribed for the management of type II diabetes mellitus and various symptoms of PCOS. It is derived from the extract of Galega officinalis.

It remediates hyperglycemia through activation of AMPK which stimulates glucose uptake and its consumption; promote fatty acid oxidation along with suppression of hepatic glucose production. It is also involved in increase GLUT4 translocation in the muscle and fat leading to decrease hepatic lipid synthesis. Moreover, It is also reported that it decreases gut absorption of glucose by increasing the glucagon-like peptide-1 (GLP-1) in this way, it reduces the insulin requirement too.All of these actions of metformin decrease insulin resistance and thus improve the state of hyperinsulinemia associated with diabetes and PCOS

Other Name: glucophage

Experimental: Probiotic
Group no 2(26 patients): will be given probiotics alone at a dose of 180mg B.D for 12 weeks
Drug: Probiotic Agent

Probiotics are live microorganisms, which when administered in adequate amounts confer a health benefit effects on the host.

Many clinical trials have been done on probiotic which show its use as a single or as an adjuvant drug therapy for various diseases with no or rare side effects. It is now frequently used agent for various diseases.

Apart from this many studies have been published related to effects of probiotics on PCOS, which shows effectiveness of probiotics when used for 8 to 12 weeks with no adverse effects observed by these micro-organisms but none of the study have compare it with standarad drug

Other Name: Ecotec

Experimental: Metformin and Probiotic
Group no 3(26 patients): will be given metformin 500mg B.D and probiotics 180mgram O.D. for 12 week
Drug: Probiotic Agent

Probiotics are live microorganisms, which when administered in adequate amounts confer a health benefit effects on the host.

Many clinical trials have been done on probiotic which show its use as a single or as an adjuvant drug therapy for various diseases with no or rare side effects. It is now frequently used agent for various diseases.

Apart from this many studies have been published related to effects of probiotics on PCOS, which shows effectiveness of probiotics when used for 8 to 12 weeks with no adverse effects observed by these micro-organisms but none of the study have compare it with standarad drug

Other Name: Ecotec

Drug: Metformin

Metformin, an insulin sensitizer, is an oral biguanide that is most commonly prescribed for the management of type II diabetes mellitus and various symptoms of PCOS. It is derived from the extract of Galega officinalis.

It remediates hyperglycemia through activation of AMPK which stimulates glucose uptake and its consumption; promote fatty acid oxidation along with suppression of hepatic glucose production. It is also involved in increase GLUT4 translocation in the muscle and fat leading to decrease hepatic lipid synthesis. Moreover, It is also reported that it decreases gut absorption of glucose by increasing the glucagon-like peptide-1 (GLP-1) in this way, it reduces the insulin requirement too.All of these actions of metformin decrease insulin resistance and thus improve the state of hyperinsulinemia associated with diabetes and PCOS

Other Name: glucophage




Primary Outcome Measures :
  1. Biochemical parameter: [ Time Frame: 12 weeks ]

    Fasting serum glucose:

    The blood sample for FBS will be collected on day 2 or 3 of the menses. The blood samples will be taken before the start and at the end of the treatment.

    fasting glucose 80-100 mg/dl


  2. Hormonal parameter: [ Time Frame: 12 weeks ]

    Androgens:

    The concentration of these hormones will be evaluated at the baseline and at the end of treatment usually in the morning between 8:00 am to 9:00 am after overnight fasting

    Serum testosterone:15 and 70 ng/dL


  3. Change in cyst size on Ultrasonography [ Time Frame: 12 weeks ]

    Ovary cyst size:

    The size of the cyst will be measured before the start and at the end of the study, considering 12 or more follicles in at least 1 ovary or both—measuring 2-9 mm in diameter—or a total ovarian volume greater than 10 cm3


  4. Luteinizing Hormone [ Time Frame: 12 weeks ]

    LH

    The concentration of this endocrine hormones is determined will be obtained on day 2 or 3 of the normal menstruation cycle and at any time in women with amenorrhea.

    LH: 1.9 to 12.5 IU/L


  5. INSULIN LEVELS [ Time Frame: 12 weeks ]

    Fasting serum insulin:

    The sample is collected after fasting of 12 to 14 hours will be measured before and after intervention

    fasting insulin < 25 mIU/L


  6. Lipid [ Time Frame: 12 weeks ]

    Lipid profile:

    1. Total cholesterol
    2. LDL
    3. HDL
    4. Triglyceride

    The serum lipid concentrations will be evaluated spectrophotometrically by means of commercial kits at baseline and at the end of the study

    Total cholesterol < 200

    Triglyceride: <150 mg/dl

    HDL: > 60mg/ dl

    LDL: < 130mg /dl


  7. Follicle-stimulating hormone [ Time Frame: 12 weeks ]

    The concentration of this endocrine hormones is determined will be obtained on day 2 or 3 of the normal menstruation cycle and at any time in women with amenorrhea.

    LH: 4.5 to 21.5 IU/L


  8. LH and FSH ratio [ Time Frame: 12 weeks ]

    LH:FSH The serum levels of FSH:LH ratio will be assessed before the start and at the end of the management on day 2 or 3 of the normal menses and at any time in women with amenorrhea.

    1.5:1



Secondary Outcome Measures :
  1. Change in Physical symptoms in PCOS [ Time Frame: 12 weeks ]

    Weight:

    The body weight of the females will be recorded at baseline and at the end of the treatment with the help of weighing machine in kg.


  2. Menstruration [ Time Frame: 12 weeks ]

    Menstrurational irregularities:

    All study participants will be asked about menstruation irregularities at the time of enrollment.They will also be enquired about for long they have their cycles have been disturbed.They will be asked to maintain their cycle dates as well.


  3. Hirsutism [ Time Frame: 12 week ]

    Hirsutism:

    History and physical examination, including pelvic examination at the start and at the end of treatment using the Ferriman-Gallwey scale for hirsutism.


  4. Acne [ Time Frame: 12 week ]

    Acne:

    Acne score will be taken at baseline and at the end of the treatment through the Global Acne grading system.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient will be included according to the Rotterdam European Society for Human Reproduction and Embryology/American Society for Reproductive Medicine sponsored a PCOS consensus criterion which says the presence of any two of the following three features must be present for the patient to be diagnosed as a case of PCOS:

    • Oligomenorrhea and/or amenorrhea (Oligomenorrhea>45 days or <8 cycles per year and amenorrhea >3 months in women with previous periodic menses) for a period of 6 months
    • Clinical and/or biochemical hyperandrogenemia, the presence of acne, hirsutism (FG score>8), and alopecia
    • Polycystic ovaries on sonography (>12 follicles in one or both ovaries, 2-9 mm in diameter and/or increased ovarian volume >10 mL).

Exclusion Criteria:

  • History of chronic diseases
  • Allergic to probiotic or metformin
  • Current or previous (within the last 6 months) use of chemotherapy or other drugs.
  • History of smoking
  • Individuals with autoimmune disease
  • Individuals with autoimmune disease.

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): NCT04009603


Locations
Layout table for location information
Pakistan
Dr. Urooj
Karachi, Sindh, Pakistan, 75300
Sponsors and Collaborators
Ziauddin University
Investigators
Layout table for investigator information
Principal Investigator: Dr.Urooj Zafar, M.Phil Ziauddin University
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Dr. Urooj Zafar, Principal Investigator, Ziauddin University
ClinicalTrials.gov Identifier: NCT04009603    
Other Study ID Numbers: 651118UZPHA
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
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