Clinical trial NCT04009603: Comparison of Probiotics, Metformin & Their Combination Therapy in the Treatment of PCOS
Official title: Comparison of Probiotics, Metformin and Their Combination Therapy in Improving Symptoms of Polycystic Ovarian Syndrome.̎- A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Biochemical parameter:
timeFrame: 12 weeks
measure: Hormonal parameter:
timeFrame: 12 weeks
measure: Change in cyst size on Ultrasonography
timeFrame: 12 weeks
measure: Luteinizing Hormone
timeFrame: 12 weeks
measure: INSULIN LEVELS
timeFrame: 12 weeks
measure: Lipid
timeFrame: 12 weeks
measure: Follicle-stimulating hormone
timeFrame: 12 weeks
measure: LH and FSH ratio
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Physical symptoms in PCOS
timeFrame: 12 weeks
measure: Menstruration
timeFrame: 12 weeks
measure: Hirsutism
timeFrame: 12 week
measure: Acne
timeFrame: 12 week
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr. Urooj
state: Sindh
Study officials:
affiliation: Ziauddin University
name: Dr.Urooj Zafar, M.Phil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.