The effects of synbiotic supplement containing Bacillus coagulans and fructooligosaccharide on Quality of life (physical and mental health status) in women with polycystic ovarian syndrome.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211108053007N1

Enrollment

Registered

2023-02-14

Start date

2023-02-19

Completion date

Unknown

Last updated

2023-03-13

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 12 weeks, they will receive daily one 2 gram sachet of synbiotic containing 10 to the power of 11 CFU/g of Bacillus coagulans, 10 to the power of 10 CFU/g Lacto

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria At least 2 weeks have passed since the diagnosis and treatment of PCOS Being in the age range of 18-45 years Being in the BMI range of 18.5-35 Willingness to cooperate

Exclusion criteria

Exclusion criteria: pregnancy Having liver diseases, kidney failure and heart failure, infectious or inflammatory diseases, thyroid gland disorders, diabetes, types of cancer and hyperprolactinemia. Consuming supplements or products containing synbiotics or probiotics in the last month Adherence to special diets or weight loss diets during the last three months Taking corticosteroids or omega-3

Design outcomes

Primary

Measure	Time frame
Emotional domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.;Hirsotism domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.;Weight domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.;Infertility Problems domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.;Menstrual Problems domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.;Physical functioning score. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: SF-12 form.;Physical functioning score. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: SF-12 form.;Perceived Stress scale (PSS-10) score. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PSS-10 form.	—

Measure

Time frame

Emotional domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.;Hirsotism domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.;Weight domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.;Infertility Problems domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.;Menstrual Problems domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.;Physical functioning score. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: SF-12 form.;Physical functioning score. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: SF-12 form.;Perceived Stress scale (PSS-10) score. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PSS-10 form.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Hariri

Shahid Beheshti University of Medical Sciences

nutrition@sbmu.ac.ir+98 21 2676 4689

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 9, 2026