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Effect of Prebiotic in Clinical and Paraclinical Parameters of Poly Cystic Ovarian Syndrom (PCOS)

Effect of Prebiotic in Clinical and Paraclinical Parameters of Poly Cystic Ovarian Syndrom (PCOS): A Triple Blind Randomized Clinical Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016062810324N33
Enrollment
62
Registered
2016-07-28
Start date
2016-08-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

clinical parameters. Polycystic ovarian syndrome

Interventions

Intervention 1: The intervention group will receive one pocket of 20 gram perbiotic that will use in the glass of water daily for three months. Intervention 2: The control group will receive one pocke
Treatment - Other
Treatment - Drugs
The intervention group will receive one pocket of 20 gram perbiotic that will use in the glass of water daily for three months.
The control group will receive one pocket of 20 gram placebo that will use in the glass of water daily for three months.

Sponsors

Vice chancellor for research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Confirming the diagnosis of PCOS by research collaborator; Age between 18 and 45 years old; Having literacy of reading and writing for completing the questionnaires; BMI between 25 and 40 kg/m2; Not taking of probiotic, prebiotics, vitamins, minerals and omega-3 during the study and three months before the intervention Exclusion criteria: Having other androgenic disorders such as adrenal hyperplasia or Androgen-secreting tumor according to assessment of research collaborator; Having thyroid diseases according to assessment of research collaborator; Having Cushing's syndrome according to assessment of research collaborator; Using of hormonal contraceptive drugs at present or previous use of hormone therapy; Pregnancy or breast-feeding; Having previous surgery on one or both ovaries; Using of cigarettes and alcohol; Severe physical activity (this is activity that during carrying out it, an individual can’t easily talk due to increased respiratory rate and breathing); Using of Dietary supplements

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Hirsutism Score. Timepoint: Before study, three and six months after starting the intervention. Method of measurement: Ferriman–Gallwey criteria.;Serum Levels of hormonal indices (DHEA-S, free testostrone). Timepoint: Before study and three months after starting the intervention. Method of measurement: Blood tests.

Secondary

MeasureTime frame
Anthropometric indices (Waist circumference, hip circumference and body mass index). Timepoint: before intervention, three and six months after starting the intervention. Method of measurement: Measuring with centimeter and scale.;Serum levels of FBS, hsCRP and Lipid profile. Timepoint: before intervention and three months after starting the intervention. Method of measurement: Blood tests.;Side events. Timepoint: During the study. Method of measurement: Checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSevda Gholizadeh shamasbi

Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences

s.gholizadeh7007@gmail.com+98 45 3352 3806

Outcome results

None listed

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