poly cystic ovary syndrome (PCOS). E28.2
Conditions
Interventions
Intervention 1: probiotic Lactobacillus/109 CFU/ 2 times per day/ for 3 months/ keep in the refrigerator/
Lactobacillus acidophilus
Lactobacillus plantarum
Lactobacillus ferme
Treatment - Drugs
probiotic Lactobacillus/109 CFU/ 2 times per day/ for 3 months/ keep in the refrigerator/
Lactobacillus acidophilus
Lactobacillus plantarum
Lactobacillus fermentum
placebo:
maltodextrin/ made by same company with exact shape, size, color/ 2 times per day/ for 3 months/ keep in the refrigerator
Sponsors
National Nutrition and Food Sciences Institute Iran, Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Target population sample of women with poly cystic ovary syndrome in women with poly cystic ovary syndrome referred to Ebne Sina hospital, Tehran, Iran. Inclusion criteria: age between 18 to 45 years ild; not using any kind of medication or supplements except Cyproterone acetate compound; no history of any chronic disease (diabetes, thyroid disease, autoimmune, cancer,..) during trial; not being professional athlete; no desire for following up an infertility treatment for the next months. Exclusion criteria: smoking; pregnancy; lactation; tend to pregnancy for next three months; getting common cold or flu more than 5 days during trial; no desire for cooperation; making the major change in diet or physical activity during trial; using any immune-oppressive medication.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hs-CRP. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: Eliza.;IL-6. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: Eliza.;IL-10. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: Eliza.;LH. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: Eliza.;FSH. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: Eliza.;DHEA. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: Eliza.;TESTOSTERONE. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: Eliza.;Serum insulin. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: Eliza.;Serum glucose. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: enzymatic method.;Dominant follicle. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: ultrasound (sonography).;Ovary size. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: ultrasound (sonography). | — |
Secondary
| Measure | Time frame |
|---|---|
| TG. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: enzymatic.;Weight. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: weight scale.;LDL. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: enzymatic.;Waist circumstance. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: meter.;BMI. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: weight(kg)/height2(m2) (Metric Units).;HOMA-IR. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: {[fasting insulin (µU/ml)] × [fasting glucose (mmol/l)]}/22.5.;The number of days of the menstrual cycle. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: questioner.;HDL. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: enzymatic.;Total cholesterol. Timepoint: beginning of trial/ end of trial (3 months later). Method of measurement: enzymatic. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNila Ghanei
Shahid Beheshti University of Medical Sciences
Outcome results
None listed