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IRCT20190523043674N1 IRCT 2019-07-10 Boushehr University of Medical Sciences Effect of fecal microbita transplantation in treatment of PCOS پیوند میکروبیوم Fecal microbiota transplantation (FMT) for treatment of polycystic ovary syndrome: a clinical trial phase I 2019-06-22 anticipated 15 Complete https://irct.ir/trial/40001 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Poly-cystic ovary syndrome. 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.. Yes - There is a plan to make this available What will be shared: The whole potential data is publishable after being unidentifiable When: Start to access the data: 6 months after publishing the results To whom: Data will only be available to researchers working in academic and scientific institutions Conditions: Contact the e-mail of scientific responsible person for project and obtain permission after providing data usage goals Where to obtain: Dr Katayun Vahdat: vahdatk@gmail.com Dr Amin Tamadon: amintamaddon@yahoo.com How to obtain: 1- Review the data request: 1 month 2- Data delivery: 1 week Comments:
public Katayoun Vahdat
Persian Gulf Biomedical Research Institute, Boostan 19 Alley, Postal Code: 7514763448, Imam Khomeini Street, Bushehr/I.R. Iran.
Boushehr Iran (Islamic Republic of) 7514763448 +98 77 3334 1827 k.vahdat@bpums.ac.ir Boushehr University of Medical Sciences scientific Katayoun Vahdat
Iranian South Medical Journal Editorial Office, The Persian Gulf Biomedical Research Institute, Boostan 19 Alley, Postal Code: 7514763448, Imam Khomeini Street, Bushehr/I.R. Iran.
Boushehr Iran (Islamic Republic of) 7514763448 +98 77 3334 1827 k.vahdat@bpums.ac.ir Boushehr University of Medical Sciences Iran (Islamic Republic of) 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 15 years 35 years Female 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 E28.2 Polycystic ovarian syndrome Treatment - Drugs 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. 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. Boushehr University of Medical Sciences Approved 2019-05-20 University/Regional Research Ethics Committee Bushehr province university of medical sciences Bushehr University of Medical Sciences, Moallem St, Bushehr, Iran. Busheher Boushehr Iran (Islamic Republic of)