Clinical trial · Interventional
Comparison of Probiotics, Metformin & Their Combination Therapy in the Treatment of PCOS
Comparison of Probiotics, Metformin and Their Combination Therapy in Improving Symptoms of Polycystic Ovarian Syndrome.̎- A Randomized Clinical Trial
NCT04009603CI-TRIAL-00045787completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Probiotic Agent | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Metformin
- description
- Group no 1(26 patients) Metformin tablets at a dose of 500mg BD for 12 weeks
- interventionNames
- Drug: Metformin
- type
- EXPERIMENTAL
- label
- Probiotic
- description
- Group no 2(26 patients): will be given probiotics alone at a dose of 180mg B.D for 12 weeks
- interventionNames
- Drug: Probiotic Agent
- type
- EXPERIMENTAL
- label
- Metformin and Probiotic
- description
- Group no 3(26 patients): will be given metformin 500mg B.D and probiotics 180mgram O.D. for 12 week
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (4)
- RESULTAhmadi 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
- RESULTShoaei 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
- RESULTKaramali 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
- RESULTLiao 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