Skip to content

Investigating the effect of two probiotic strains on the symptoms of polycystic ovary syndrome

Investigating the effect of suuplementation with two probiotic strains (Lactobacillus helveticus, Bifidobacterium longum) on cardiometabolic profile, hormonal status, oxidative stress and quality of life in women with polycystic ovary syndrome: a randomized double-blind controlled clinical trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20121216011763N62
Enrollment
90
Registered
2024-03-30
Start date
2024-06-20
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: For 8 weeks, daily intake of one capsule containing two strains of probiotics (Lactobacillus helveticus with a dose of 109 x 3 and Bifidobacterium longum with a dos

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
14 Years to 55 Years

Inclusion criteria

Inclusion criteria: - Patients who agree to participate in the study. - Diagnosis of polycystic ovary syndrome by obstetrician and gynecologist according to the Rotterdam criteria

Exclusion criteria

Exclusion criteria: - Pregnancy and breastfeeding - Consumption of probiotic supplements or products during the last four weeks - Suffering from mental illnesses (major depression, bipolar disorder, and schizophrenia) based on the patient's statement or history of hospitalization in a mental hospital or history of taking psychoactive drugs - Hyperprolactinemia Menopause Uncontrolled diabetes(according to glycosylated hemoglobin index, 8% = HbA1C) Suffering from chronic diseases such as cardiovascular, liver, kidney, neoplasm Performing laparoscopic surgery of ovaries and assisted reproduction technology

Design outcomes

Primary

MeasureTime frame
The mean level of fasting blood sugar (FBS) among the intervention and control groups. Timepoint: Before and after intervention. Method of measurement: Fasting blood sample (10 cc of venous blood).;The average level of total cholesterol (HDL, LDL, TG) in the intervention and control groups. Timepoint: before and after intervention. Method of measurement: Fasting blood sample (10 cc of venous blood).;The mean serum level of CRP among intervention and control groups. Timepoint: Before and after intervention. Method of measurement: Fasting blood sample (10 cc of venous blood).;The mean serum level of malondialdehyde (MDA) among intervention and control groups. Timepoint: before and after intervention. Method of measurement: Fasting blood sample (10 cc of venous blood).;The mean level of total antioxidant capacity (TAC) among intervention and control groups. Timepoint: Before and after intervention. Method of measurement: Fasting blood sample (10 cc of venous blood).;The average serum level of superoxide dismutase enzyme (SOD) among intervention and control groups. Timepoint: before and after intervention. Method of measurement: Fasting blood sample (10 cc of venous blood).;The mean serum level of fasting insulin (Insulin) among the intervention and control groups. Timepoint: before and after intervention. Method of measurement: Fasting blood sample (10 cc of venous blood).;The mean serum total testosterone level among the intervention and control groups. Timepoint: Before and after intervention. Method of measurement: Fasting blood sample (10 cc of venous blood).;The mean serum level of sex hormone-binding globulin (SHBG) among the intervention and control groups. Timepoint: Before and after intervention. Method of measurement: Fasting blood sample (10 cc of venous blood).;The average score of mental health indicators (stress, anxiety and depression) among the intervention and control groups. Timepoint: Before and after the intervention. Method of measurement: DASS-21

Secondary

MeasureTime frame
The mean of quicki index (insulin sensitivity) among intervention and control groups. Timepoint: Before and after intervention. Method of measurement: QUICKI = 1/[log(I0) + log(G0)].;The mean of HOMA-IR index (insulin resistance index) among intervention and control groups. Timepoint: Before and after intervrntion. Method of measurement: HOMA-IR = [) fasting insulin) µU/ml (× fasting glucose) mmo/l ((]/22.5.;The mean of FAI index (free androgen index) among intervention and control groups. Timepoint: Before and after intervention. Method of measurement: FAI = 100 × (Total Testosterone) /SHBG.;Severity of alopecia among intervention and control groups. Timepoint: Before and after intervention. Method of measurement: Alopecia evaluation questionnaire.;Acne severity among intervention and control groups. Timepoint: Before and after intervention. Method of measurement: Acne evaluation questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholamreza Askari

Esfahan University of Medical Sciences

askari@mui.ac.ir+98 31 3792 3060

Outcome results

None listed

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