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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-06

Study Completion Date

2020-01-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03336840

Polycystic Ovary Syndrome

UNKNOWN NA

Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

NCT03757923

Menstrual Irregularities Hyperandrogenism

UNKNOWN PHASE1/PHASE2

Comparison of Myoinositol and Metformin in PCO

NCT04204044

PCOS

UNKNOWN EARLY_PHASE1

Serum Biomarker Levels Improvement in Poly Cystic Ovarian Syndrome: Impact of Metformin Compared to Healthy Controls

NCT06479434

Polycystic Ovary Syndrome Insulin Resistance

COMPLETED NA

Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

NCT06170463

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metformin

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

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type 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

Probiotic

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

Group Type EXPERIMENTAL

Probiotic Agent

Intervention Type 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

Metformin and Probiotic

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

Group Type EXPERIMENTAL

Probiotic Agent

Intervention Type 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

Metformin

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ecotec glucophage

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No