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

NCT04009603 | Completed

• 1 other identifier: 651118UZPHA
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (8)

• Biochemical parameter:

  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

  12 weeks

• Hormonal parameter:

  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

  12 weeks

• Change in cyst size on Ultrasonography

  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

  12 weeks

• Luteinizing Hormone

  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

  12 weeks

• INSULIN LEVELS

  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

  12 weeks

• Lipid

  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

  12 weeks

• Follicle-stimulating hormone

  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

  12 weeks

• LH and FSH ratio

  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

  12 weeks

Secondary Outcomes (4)

• Change in Physical symptoms in PCOS

  12 weeks

• Menstruration

  12 weeks

• Hirsutism

  12 week

• Acne

  12 week

Study Arms (3)

Metformin

ACTIVE COMPARATOR

Group no 1(26 patients) Metformin tablets at a dose of 500mg BD for 12 weeks

Drug: Metformin

Probiotic

EXPERIMENTAL

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

Drug: Probiotic Agent

Metformin and Probiotic

EXPERIMENTAL

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

Drug: Probiotic Agent; Drug: Metformin

Interventions

Probiotic Agent DRUG

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

Also known as: Ecotec

Metformin and Probiotic; Probiotic

Metformin DRUG

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

Also known as: glucophage

Metformin; Metformin and Probiotic

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Dr. Urooj

Karachi, Sindh, 75300, Pakistan

Location

Related Publications (4)

• Ahmadi S, Jamilian M, Karamali M, Tajabadi-Ebrahimi M, Jafari P, Taghizadeh M, Memarzadeh MR, Asemi Z. Probiotic supplementation and the effects on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial. Hum Fertil (Camb). 2017 Dec;20(4):254-261. doi: 10.1080/14647273.2017.1283446. Epub 2017 Feb 1.

  PMID: 28142296 RESULT

• Shoaei T, Heidari-Beni M, Tehrani HG, Feizi A, Esmaillzadeh A, Askari G. Effects of Probiotic Supplementation on Pancreatic beta-cell Function and C-reactive Protein in Women with Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Clinical Trial. Int J Prev Med. 2015 Mar 24;6:27. doi: 10.4103/2008-7802.153866. eCollection 2015.

  PMID: 25949777 RESULT

• Karamali M, Eghbalpour S, Rajabi S, Jamilian M, Bahmani F, Tajabadi-Ebrahimi M, Keneshlou F, Mirhashemi SM, Chamani M, Hashem Gelougerdi S, Asemi Z. Effects of Probiotic Supplementation on Hormonal Profiles, Biomarkers of Inflammation and Oxidative Stress in Women With Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. Arch Iran Med. 2018 Jan 1;21(1):1-7.

  PMID: 29664663 RESULT

• Liao D, Zhong C, Li C, Mo L, Liu Y. Meta-analysis of the effects of probiotic supplementation on glycemia, lipidic profiles, weight loss and C-reactive protein in women with polycystic ovarian syndrome. Minerva Med. 2018 Dec;109(6):479-487. doi: 10.23736/S0026-4806.18.05728-2. Epub 2018 Sep 24.

  PMID: 30256077 RESULT

Related Links

• Effects of Probiotic Supplementation on Pancreatic β-cell Function and C-reactive Protein in Women with Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Clinical Tria
• Meta-analysis of the effects of probiotic supplementation on glycemia, lipidic profiles, weight loss and C-reactive protein in women with polycystic ovarian syndrome.

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Dr.Urooj Zafar, M.Phil

  Ziauddin University

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: July 5, 2019
• Study Start: December 6, 2018
• Primary Completion: June 30, 2019
• Study Completion: January 28, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)