Poly Cystic Ovary SyndromeMEP-PCOSNCT07874646
Efficacy of Metformin With and Without Probiotics in Women With PCOS
A study testing Metformin and Probiotics in people with Poly Cystic Ovary Syndrome, run by Dhivyaprasath Palaniappan at 1 site in India.
Trial summary
This prospective interventional study evaluated the effectiveness of metformin alone compared with metformin combined with probiotics in women with polycystic ovary syndrome (PCOS). The study included women aged 18-45 years diagnosed with PCOS according to the Rotterdam criteria. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Poly Cystic Ovary Syndrome
- What is being tested?
- Metformin and Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 27 Mar 2024to 27 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women aged 18-45 years.
- Diagnosis of PCOS based on the Rotterdam criteria.
- Body mass index (BMI) between 18.5 and 35 kg/m2.
Who cannot join
- Pregnancy or lactation
- Use of hormonal medications or supplements within the past 3 months.
- History of chronic gastrointestinal disorders
- Severe hepatic or renal impairment.
- Known allergy or intolerance to metformin.
- T2DM,Thyroid disorder,adrenal hyperplasia.
- Intake of antiobesity and antidepressants in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Efficacy of Metformin and Metformin With Probiotics in the Management of Polycystic Ovary Syndrome (PCOS): A Prospective Interventional Study
This prospective interventional study evaluated the effectiveness of metformin alone compared with metformin combined with probiotics in women with polycystic ovary syndrome (PCOS). The study included women aged 18-45 years diagnosed with PCOS according to the Rotterdam criteria. Participants received either metformin alone or metformin combined with probiotic supplementation for 12 weeks. The study assessed changes in hormonal parameters such as total testosterone (TT), sex hormone-binding globulin (SHBG), and free androgen index (FAI) to determine whether adding probiotics to metformin provided additional benefits in the management of PCOS.
Read the detailed description
- Polycystic ovary syndrome (PCOS) is a heterogeneous endocrine and metabolic disorder that commonly affects women of reproductive age. The condition is characterized by a combination of ovulatory dysfunction, hyperandrogenism, and polycystic ovarian morphology. Women with PCOS may experience irregular menstrual cycles, anovulation, clinical manifestations of androgen excess such as hirsutism, and metabolic abnormalities including insulin resistance and altered glucose and lipid metabolism. The clinical presentation varies considerably between individuals, and management may therefore require a combination of pharmacological and lifestyle-based approaches.
- Insulin resistance and compensatory hyperinsulinemia are important metabolic features in many women with PCOS. Increased insulin concentrations may contribute to excessive ovarian androgen production and may further aggravate reproductive and metabolic abnormalities. Metformin, a biguanide antidiabetic medicine, has been widely investigated and used in PCOS management because of its effects on insulin sensitivity and glucose metabolism. Metformin may also contribute to improvements in menstrual cyclicity, ovulatory function, and androgen-related abnormalities in selected women with PCOS.
- In addition to conventional pharmacological treatment, increasing evidence has suggested a potential relationship between the gut microbiota and the pathophysiology of PCOS. Alterations in the composition and function of the intestinal microbiota, commonly referred to as gut dysbiosis, have been reported in women with PCOS. Proposed mechanisms linking gut microbiota alterations with PCOS include changes in intestinal barrier function, inflammatory pathways, metabolic regulation, insulin sensitivity, and interactions between the gut microbiota and endocrine pathways.
- Probiotics are live microorganisms that, when administered in adequate amounts, may provide health benefits to the host. Probiotic supplementation has been investigated in PCOS because of its potential effects on intestinal microbial balance, inflammation, oxidative stress, insulin sensitivity, and metabolic and hormonal parameters. Previous clinical studies have reported variable effects of probiotics on body weight, glucose metabolism, lipid profiles, inflammatory markers, sex hormone-binding globulin (SHBG), and other clinical or biochemical outcomes in women with PCOS. However, findings across studies have not been consistent, and further clinical evaluation of probiotics as an adjunct to conventional PCOS treatment remains relevant.
- The present prospective interventional study was conducted to compare the effects of metformin alone with those of metformin combined with probiotic supplementation in women diagnosed with PCOS. The primary purpose was to investigate whether the addition of probiotic supplementation to metformin could provide additional benefits compared with metformin alone in the management of PCOS, particularly with respect to hormonal parameters and menstrual regularity.
- The study was conducted at Vivekanandha Medical Care Hospital, Elayampalayam, Tiruchengode, Tamil Nadu, India. The study was carried out from March 2024 through August 2024. The study protocol received approval from the Institutional Ethics Committee before participant enrollment. Written informed consent was obtained from eligible participants before participation in the study.
- Women aged 18 to 45 years who were premenopausal and diagnosed with PCOS according to the Rotterdam diagnostic criteria were considered for participation. The Rotterdam criteria require the presence of at least two of the following three features, after appropriate exclusion of other relevant conditions: oligo- or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology. Participants were required to have a body mass index between 18.5 and 35 kg/m².
- Women were excluded if they were pregnant or lactating, had used hormonal medications or relevant supplements within the previous three months, had a history of chronic gastrointestinal disorders, severe hepatic or renal impairment, or known allergy or intolerance to metformin. Women with type 2 diabetes mellitus, thyroid disorders, or adrenal hyperplasia were also excluded. Participants who had used anti-obesity medications or antidepressants during the previous three months were excluded according to the study protocol.
- Approximately 60 eligible participants were included in the study. Participants were allocated into two treatment groups according to the study's predefined allocation procedure and patient preference. The study therefore used a non-randomized comparative interventional design and was not a randomized controlled trial.
- One treatment group received metformin alone. The second treatment group received metformin in combination with probiotic supplementation. Metformin was administered at a dose of 500 mg twice daily. Participants receiving combination treatment additionally received a probiotic capsule twice daily after meals. The probiotic formulation contained fructooligosaccharide and multiple probiotic microorganisms, including Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, Bifidobacterium longum, Saccharomyces boulardii, and Streptococcus thermophilus. Treatment was continued for approximately 12 weeks.
- The study evaluated the effects of the two treatment approaches on hormonal and clinical parameters associated with PCOS. Particular attention was given to androgen-related hormonal parameters, including total testosterone (TT), sex hormone-binding globulin (SHBG), and free androgen index (FAI), together with menstrual regularity. Free androgen index was calculated from the relevant testosterone and SHBG measurements according to the study protocol.
- Clinical outcomes included menstrual regularity, body mass index, and hirsutism. Quality of life was also assessed using the PCOS-specific quality-of-life assessment included in the study protocol. These outcomes were evaluated to determine whether the addition of probiotic supplementation to metformin was associated with additional clinical benefits compared with metformin treatment alone.
- Hormonal laboratory investigations were performed according to the study protocol. Blood samples were collected during the appropriate phase of the menstrual cycle and under fasting conditions. Serum samples were processed and stored according to the laboratory procedures specified in the study protocol. Hormonal parameters were subsequently assessed using the laboratory methods available at the study site.
- The primary outcome of the study was the change in androgen-related hormonal parameters and menstrual regularity following the 12-week intervention. The protocol specifically identified changes in serum free testosterone concentration, free androgen index, and menstrual regularity as primary outcomes. Secondary outcomes included changes in body mass index, hirsutism by PCOS quality-of-life measures.
- The study also considered the tolerability and occurrence of adverse reactions associated with the interventions. Participants were monitored during the intervention period, and relevant complaints or adverse effects reported during follow-up were documented.
- Data were obtained directly from participants through interviews and from clinical and laboratory records. Relevant demographic, clinical, treatment, and laboratory information was recorded using the study data collection form. Participant confidentiality was maintained throughout the study. Personal identifying information was collected only when necessary for participant follow-up and was handled confidentially.
- The study was performed following approval from the Institutional Ethics Committee. Before enrolment, participants were informed about the purpose and procedures of the study, the interventions involved, potential benefits and risks, confidentiality of their information, and their right to decline participation or withdraw without negative consequences. Written informed consent was obtained from participants before study-related procedures were performed.
- The rationale for comparing the two treatment approaches was based on the established role of metformin in the management of metabolic and reproductive features of PCOS and the emerging evidence regarding the possible role of gut microbiota modulation in PCOS. The addition of probiotics was investigated as an adjunctive approach rather than as a replacement for metformin. The study was designed to determine whether combined treatment could produce greater improvements in selected hormonal and clinical outcomes than metformin alone.
- The study was initiated following protocol development and Institutional Ethics Committee approval. The first participant was enrolled on 27 March 2024. The final study activities and data collection were completed on 30 August 2024. The study included approximately 60 participants and had a treatment and follow-up period of approximately 12 weeks for each participant.
- The study findings are intended to contribute to the clinical evidence concerning the potential role of probiotic supplementation as an adjunct to metformin therapy in women with PCOS. In particular, the study provides comparative information regarding hormonal parameters, menstrual regularity, body mass index, hirsutism, and quality of life. The findings may help inform future research evaluating the role of gut microbiota-directed interventions alongside established pharmacological approaches for PCOS.
- The study should be interpreted in the context of its design and setting. It was a prospective interventional study conducted at a single medical centre with a relatively small sample size and a 12-week intervention period. Participant allocation was based on patient preference rather than randomization, and therefore the study does not provide the same level of evidence as a randomized controlled trial. The findings may not be generalizable to all women with PCOS or to populations with different demographic or clinical characteristics. Larger, multicentre, randomized controlled studies with longer follow-up may be required to confirm the findings and further investigate the clinical role of probiotics as an adjunct to metformin in PCOS.
- Overall, this study evaluated whether combining probiotic supplementation with metformin could provide additional benefits over metformin alone in women with PCOS. The study focused on hormonal and clinical manifestations of PCOS and assessed changes in androgen-related parameters, menstrual regularity, body mass index, hirsutism, and quality of life following a 12-week intervention.
- Conditions
- Poly Cystic Ovary Syndrome
- Being tested
- Metformin, Probiotics
- Keywords
- Polycystic Ovary Syndrome, PCOS, Metformin, Probiotics, Hormonal profile, Menstrual regularity, Hyperandrogenism, Free androgen index, Sex hormone-binding globulin
- Medical subject headings
- Polycystic Ovary Syndrome, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin 500 mg was administered orally twice daily for 12 weeks as the standard treatment for participants with polycystic ovary syndrome (PCOS).
ProbioticsDietary supplement
A probiotic capsule was administered orally twice daily after meals for 12 weeks in combination with metformin. Each capsule contained fructooligosaccharide 300 mg and Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, Bifidobacterium longum, Saccharomyces boulardii, and Streptococcus thermophilus.
| Study group | Role | What they receive |
|---|---|---|
| Metformin alone | Active comparator | Participants received metformin 500 mg twice daily for 12 weeks. Receives: Drug: Metformin |
| Metformin + Probiotics | Experimental | Participants received metformin 500 mg twice daily combined with a probiotic capsule twice daily after meals for 12 weeks. Receives: Drug: Metformin; Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum free testosterone concentration
Serum free testosterone will be measured in a fasting blood sample. The change from baseline to the end of the intervention will be compared between women receiving metformin plus probiotics and women receiving metformin alone. Unit of measure: ng/dL.
Measured: Baseline and 3 months
Change in free androgen index
Free androgen index will be calculated as total testosterone divided by sex hormone binding globulin, multiplied by 100. The change from baseline to the end of the intervention will be compared between the two groups. Unit of measure: unitless index.
Measured: Baseline and 3 months
Menstrual regularity
Menstrual regularity will be assessed from participant-reported cycle dates. A cycle is counted as regular when its length is 21 to 35 days. The number of women with regular cycles at the end of the intervention will be compared between the two groups. Unit of measure: number of participants.
Measured: 3 months
Secondary outcomes (2)
Change in polycystic ovary syndrome quality of life score
Quality of life will be assessed using the Polycystic Ovary Syndrome Quality of Life Questionnaire. Each item is scored from 1 to 5: 5 = never (no effect on quality of life), 4 = seldom, 3 = quite often, 2 = very often, 1 = always (maximal effect on quality of life). The minimum score is 1, and the maximum score is 5. A higher score means a better outcome, meaning less effect of polycystic ovary syndrome on quality of life. Interpretation: 1 to less than 3 = marked effect on quality of life; 3 to less than 4 = marginal effect; 4 to less than 5 = minimal effect; 5 = no effect. The change from baseline to the end of the intervention will be compared between women receiving metformin plus probiotics and women receiving metformin alone. Unit of measure: score on a scale.
Measured: Baseline and 3 months
Change in body mass index (BMI)
Weight and height will be measured and combined to report BMI. The change from baseline to the end of the intervention will be compared between the two groups. Unit of measure: kg/m².
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start27 Mar 2024
- Primary completion30 Aug 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poly Cystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective interventional study, but it is not a drug-development trial intended to evaluate a new investigational drug through Phases 1-4. we are studying metformin ± probiotics in women with PCOS in a clinical research setting.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhivyaprasath Palaniappan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dhivyaprasath Palaniappan, Swamy Vivekanandha College of Pharmacy
- Investigators
- Dhivyaprasath P, Pharm D, Principal investigator, Swamy Vivekanandha College of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874646
- Sponsor's protocol ID
- SVCP/IEC/DEC/2023/82
- Other IDs
- EC/NEW/INIT/2021/1811
- Acronym
- MEP-PCOS
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly because the study involves sensitive participant information. Data may be made available in a de-identified form upon reasonable request, subject to applicable ethical, privacy, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Metformin and Metformin With Probiotics in the Management of Polycystic Ovary Syndrome (PCOS): A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT07874646
- Acronym / sponsor ID
- MEP-PCOS / SVCP/IEC/DEC/2023/82
- Conditions
- Poly Cystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, PCOS, Metformin, Probiotics, Hormonal profile, Menstrual regularity, Hyperandrogenism, Free androgen index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dhivyaprasath PalaniappanUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective interventional study evaluated the effectiveness of metformin alone compared with metformin combined with probiotics in women with polycystic ovary syndrome (PCOS). The study included women aged 18-45 years diagnosed with PCOS according to the Rotterdam criteria. Participants received either metformin alone or metformin combined with probiotic supplementation for 12 weeks. The study assessed changes in hormonal parameters such as total testosterone (TT), sex hormone-binding globulin (SHBG), and free androgen index (FAI) to determine whether adding probiotics to metformin provided additional benefits in the management of PCOS.
Detailed description
- Polycystic ovary syndrome (PCOS) is a heterogeneous endocrine and metabolic disorder that commonly affects women of reproductive age. The condition is characterized by a combination of ovulatory dysfunction, hyperandrogenism, and polycystic ovarian morphology. Women with PCOS may experience irregular menstrual cycles, anovulation, clinical manifestations of androgen excess such as hirsutism, and metabolic abnormalities including insulin resistance and altered glucose and lipid metabolism. The clinical presentation varies considerably between individuals, and management may therefore require a combination of pharmacological and lifestyle-based approaches.
- Insulin resistance and compensatory hyperinsulinemia are important metabolic features in many women with PCOS. Increased insulin concentrations may contribute to excessive ovarian androgen production and may further aggravate reproductive and metabolic abnormalities. Metformin, a biguanide antidiabetic medicine, has been widely investigated and used in PCOS management because of its effects on insulin sensitivity and glucose metabolism. Metformin may also contribute to improvements in menstrual cyclicity, ovulatory function, and androgen-related abnormalities in selected women with PCOS.
- In addition to conventional pharmacological treatment, increasing evidence has suggested a potential relationship between the gut microbiota and the pathophysiology of PCOS. Alterations in the composition and function of the intestinal microbiota, commonly referred to as gut dysbiosis, have been reported in women with PCOS. Proposed mechanisms linking gut microbiota alterations with PCOS include changes in intestinal barrier function, inflammatory pathways, metabolic regulation, insulin sensitivity, and interactions between the gut microbiota and endocrine pathways.
- Probiotics are live microorganisms that, when administered in adequate amounts, may provide health benefits to the host. Probiotic supplementation has been investigated in PCOS because of its potential effects on intestinal microbial balance, inflammation, oxidative stress, insulin sensitivity, and metabolic and hormonal parameters. Previous clinical studies have reported variable effects of probiotics on body weight, glucose metabolism, lipid profiles, inflammatory markers, sex hormone-binding globulin (SHBG), and other clinical or biochemical outcomes in women with PCOS. However, findings across studies have not been consistent, and further clinical evaluation of probiotics as an adjunct to conventional PCOS treatment remains relevant.
- The present prospective interventional study was conducted to compare the effects of metformin alone with those of metformin combined with probiotic supplementation in women diagnosed with PCOS. The primary purpose was to investigate whether the addition of probiotic supplementation to metformin could provide additional benefits compared with metformin alone in the management of PCOS, particularly with respect to hormonal parameters and menstrual regularity.
- The study was conducted at Vivekanandha Medical Care Hospital, Elayampalayam, Tiruchengode, Tamil Nadu, India. The study was carried out from March 2024 through August 2024. The study protocol received approval from the Institutional Ethics Committee before participant enrollment. Written informed consent was obtained from eligible participants before participation in the study.
- Women aged 18 to 45 years who were premenopausal and diagnosed with PCOS according to the Rotterdam diagnostic criteria were considered for participation. The Rotterdam criteria require the presence of at least two of the following three features, after appropriate exclusion of other relevant conditions: oligo- or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology. Participants were required to have a body mass index between 18.5 and 35 kg/m².
- Women were excluded if they were pregnant or lactating, had used hormonal medications or relevant supplements within the previous three months, had a history of chronic gastrointestinal disorders, severe hepatic or renal impairment, or known allergy or intolerance to metformin. Women with type 2 diabetes mellitus, thyroid disorders, or adrenal hyperplasia were also excluded. Participants who had used anti-obesity medications or antidepressants during the previous three months were excluded according to the study protocol.
- Approximately 60 eligible participants were included in the study. Participants were allocated into two treatment groups according to the study's predefined allocation procedure and patient preference. The study therefore used a non-randomized comparative interventional design and was not a randomized controlled trial.
- One treatment group received metformin alone. The second treatment group received metformin in combination with probiotic supplementation. Metformin was administered at a dose of 500 mg twice daily. Participants receiving combination treatment additionally received a probiotic capsule twice daily after meals. The probiotic formulation contained fructooligosaccharide and multiple probiotic microorganisms, including Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, Bifidobacterium longum, Saccharomyces boulardii, and Streptococcus thermophilus. Treatment was continued for approximately 12 weeks.
- The study evaluated the effects of the two treatment approaches on hormonal and clinical parameters associated with PCOS. Particular attention was given to androgen-related hormonal parameters, including total testosterone (TT), sex hormone-binding globulin (SHBG), and free androgen index (FAI), together with menstrual regularity. Free androgen index was calculated from the relevant testosterone and SHBG measurements according to the study protocol.
- Clinical outcomes included menstrual regularity, body mass index, and hirsutism. Quality of life was also assessed using the PCOS-specific quality-of-life assessment included in the study protocol. These outcomes were evaluated to determine whether the addition of probiotic supplementation to metformin was associated with additional clinical benefits compared with metformin treatment alone.
- Hormonal laboratory investigations were performed according to the study protocol. Blood samples were collected during the appropriate phase of the menstrual cycle and under fasting conditions. Serum samples were processed and stored according to the laboratory procedures specified in the study protocol. Hormonal parameters were subsequently assessed using the laboratory methods available at the study site.
- The primary outcome of the study was the change in androgen-related hormonal parameters and menstrual regularity following the 12-week intervention. The protocol specifically identified changes in serum free testosterone concentration, free androgen index, and menstrual regularity as primary outcomes. Secondary outcomes included changes in body mass index, hirsutism by PCOS quality-of-life measures.
- The study also considered the tolerability and occurrence of adverse reactions associated with the interventions. Participants were monitored during the intervention period, and relevant complaints or adverse effects reported during follow-up were documented.
- Data were obtained directly from participants through interviews and from clinical and laboratory records. Relevant demographic, clinical, treatment, and laboratory information was recorded using the study data collection form. Participant confidentiality was maintained throughout the study. Personal identifying information was collected only when necessary for participant follow-up and was handled confidentially.
- The study was performed following approval from the Institutional Ethics Committee. Before enrolment, participants were informed about the purpose and procedures of the study, the interventions involved, potential benefits and risks, confidentiality of their information, and their right to decline participation or withdraw without negative consequences. Written informed consent was obtained from participants before study-related procedures were performed.
- The rationale for comparing the two treatment approaches was based on the established role of metformin in the management of metabolic and reproductive features of PCOS and the emerging evidence regarding the possible role of gut microbiota modulation in PCOS. The addition of probiotics was investigated as an adjunctive approach rather than as a replacement for metformin. The study was designed to determine whether combined treatment could produce greater improvements in selected hormonal and clinical outcomes than metformin alone.
- The study was initiated following protocol development and Institutional Ethics Committee approval. The first participant was enrolled on 27 March 2024. The final study activities and data collection were completed on 30 August 2024. The study included approximately 60 participants and had a treatment and follow-up period of approximately 12 weeks for each participant.
- The study findings are intended to contribute to the clinical evidence concerning the potential role of probiotic supplementation as an adjunct to metformin therapy in women with PCOS. In particular, the study provides comparative information regarding hormonal parameters, menstrual regularity, body mass index, hirsutism, and quality of life. The findings may help inform future research evaluating the role of gut microbiota-directed interventions alongside established pharmacological approaches for PCOS.
- The study should be interpreted in the context of its design and setting. It was a prospective interventional study conducted at a single medical centre with a relatively small sample size and a 12-week intervention period. Participant allocation was based on patient preference rather than randomization, and therefore the study does not provide the same level of evidence as a randomized controlled trial. The findings may not be generalizable to all women with PCOS or to populations with different demographic or clinical characteristics. Larger, multicentre, randomized controlled studies with longer follow-up may be required to confirm the findings and further investigate the clinical role of probiotics as an adjunct to metformin in PCOS.
- Overall, this study evaluated whether combining probiotic supplementation with metformin could provide additional benefits over metformin alone in women with PCOS. The study focused on hormonal and clinical manifestations of PCOS and assessed changes in androgen-related parameters, menstrual regularity, body mass index, hirsutism, and quality of life following a 12-week intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective interventional study, but it is not a drug-development trial intended to evaluate a new investigational drug through Phases 1-4. we are studying metformin ± probiotics in women with PCOS in a clinical research setting.
| Arm | Type | Receives |
|---|---|---|
| Metformin alone | Active comparator | Drug: MetforminParticipants received metformin 500 mg twice daily for 12 weeks. |
| Metformin + Probiotics | Experimental | Drug: Metformin, Dietary Supplement: ProbioticsParticipants received metformin 500 mg twice daily combined with a probiotic capsule twice daily after meals for 12 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Premenopausal women aged 18-45 years.
- Diagnosis of PCOS based on the Rotterdam criteria.
- Body mass index (BMI) between 18.5 and 35 kg/m2.
Key exclusion criteria (7 listed)
- Pregnancy or lactation
- Use of hormonal medications or supplements within the past 3 months.
- History of chronic gastrointestinal disorders
- Severe hepatic or renal impairment.
- Known allergy or intolerance to metformin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin 500 mg was administered orally twice daily for 12 weeks as the standard treatment for participants with polycystic ovary syndrome (PCOS). | Drug | Metformin + Probiotics, Metformin alone |
| ProbioticsA probiotic capsule was administered orally twice daily after meals for 12 weeks in combination with metformin. Each capsule contained fructooligosaccharide 300 mg and Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, Bifidobacterium longum, Saccharomyces boulardii, and Streptococcus thermophilus. | Dietary supplement | Metformin + Probiotics |
Primary outcome
Change in serum free testosterone concentration
Time frame: Baseline and 3 months
Serum free testosterone will be measured in a fasting blood sample. The change from baseline to the end of the intervention will be compared between women receiving metformin plus probiotics and women receiving metformin alone. Unit of measure: ng/dL.
Change in free androgen index
Time frame: Baseline and 3 months
Free androgen index will be calculated as total testosterone divided by sex hormone binding globulin, multiplied by 100. The change from baseline to the end of the intervention will be compared between the two groups. Unit of measure: unitless index.
Menstrual regularity
Time frame: 3 months
Menstrual regularity will be assessed from participant-reported cycle dates. A cycle is counted as regular when its length is 21 to 35 days. The number of women with regular cycles at the end of the intervention will be compared between the two groups. Unit of measure: number of participants.
2 secondary outcomes
Change in polycystic ovary syndrome quality of life score
Time frame: Baseline and 3 months
Change in body mass index (BMI)
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because the study involves sensitive participant information. Data may be made available in a de-identified form upon reasonable request, subject to applicable ethical, privacy, and institutional requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhivyaprasath P, Pharm D principal investigator
Swamy Vivekanandha College of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin and Probiotics in people with Poly Cystic Ovary Syndrome, run by Dhivyaprasath Palaniappan at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum free testosterone concentration (time frame: Baseline and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.