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Effect of fecal microbita transplantation in treatment of PCOS

Fecal microbiota transplantation (FMT) for treatment of polycystic ovary syndrome: a clinical trial phase I

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190523043674N1
Enrollment
15
Registered
2019-07-10
Start date
2019-06-22
Completion date
Unknown
Last updated
2019-10-07

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

Conditions

Poly-cystic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention group:oral administration of 40 fecal microbial capsules by each patient in a 3-hour period which is porduce in a laboratory in Bushehr University of Medical Sciences..

Sponsors

Boushehr University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 35 Years

Inclusion criteria

Inclusion criteria: Adult women 15-35 Currently diagnosed PCOS patient without treatment PCOS patient with long time treatment According to Rotterdam criteria patient must have menstural irregularity, hyperandrogenism and PCOS ultrasonography indices and must not have other diseases (at least two criteria) More than 1 month menstural irregularity More than 3 months secondary amenorrhea Hyperandrogenism signs including acnea and hirsutism Hyperandrogenemia (total testosterone of serum >0/5 ng/mL) Non-smoker, without any addiction and non-alcohol consumer patients Obese patient (BMI>20) Abnormal uterine bleeding

Exclusion criteria

Exclusion criteria: Any GI disorders Immuno-compromised patients or usage of immuno-suppressant drugs Improving of PCO symptoms after treatment with drugs Food Allergy Chronic diarrhea Antibiotic intake 3 days before transplantation Any history of cancer Congenital diseases such as adrenal hyperplesia Cushing's disease Acromegaly & Gigantism Type 1& 2 Diabetes

Design outcomes

Primary

MeasureTime frame
Removal of irregular mensuration. Timepoint: At the beginning of the study (before the intervention) and 7, 28 and 84 days after fecal microbial transplantation. Method of measurement: Questioner.;Removal of ultrasonography PCOS symptoms. Timepoint: At the beginning of the study (before the intervention) and 7, 28 and 84 days after fecal microbial transplantation. Method of measurement: ultrasonography.;Removal of secondary amenorrhea. Timepoint: At the beginning of the study (before the intervention) and 7, 28 and 84 days after fecal microbial transplantation. Method of measurement: Questioner.;Removing hyperandrogenemia. Timepoint: At the beginning of the study (before the intervention) and 7, 28 and 84 days after fecal microbial transplantation. Method of measurement: Questioner and blood sexual hormone concentration.;Decreasing the relative obesity. Timepoint: At the beginning of the study (before the intervention) and 7, 28 and 84 days after fecal microbial transplantation. Method of measurement: Body mass index.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKatayoun Vahdat

Boushehr University of Medical Sciences

k.vahdat@bpums.ac.ir+98 77 3334 1827

Outcome results

None listed

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