Effect of supplementation in treatment of women with polycystic ovary syndrome

Clinical trial of the effect of probiotic supplementation in comparison with placebo on metabolic profiles in women with polycystic ovary syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201508025623N50

Enrollment

Registered

2015-08-17

Start date

2015-08-03

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome. Sclerocystic ovary syndrome Stein-Leventhal syndrome

Interventions

Intervention 1: Intervention group: Probiotic capsule, Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally.

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women aged 18-40 years Diagnosed with PCOS

Exclusion criteria

Exclusion criteria: T2DM Liver disease History of cardiac or renal failure Thyroid disease Adrenal hyperplasia Intake of antiobesity and antidepressants in the last 3 months Smoking Taking other forms of probiotics including probiotic yogurt, kefir and other fermented foods Taking antibiotics.

Design outcomes

Primary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculated according to the formula.;Insulin sensitivity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculated according to the formula.	—

Measure

Time frame

Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculated according to the formula.;Insulin sensitivity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculated according to the formula.

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Secondary

Measure	Time frame
Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Weight loss. Timepoint: 12 weeks after the intervention. Method of measurement: Scale.;Body mass index loss. Timepoint: 12 weeks after the intervention. Method of measurement: Calculated according to the formula.	—

Measure

Time frame

Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Weight loss. Timepoint: 12 weeks after the intervention. Method of measurement: Scale.;Body mass index loss. Timepoint: 12 weeks after the intervention. Method of measurement: Calculated according to the formula.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026