Removal of suspected microbiome in PCOS patients and replacement with intestinal microbiome of healthy person
Design
Clinical trial with self-control, no blindness, non-randomized
Settings and conduct
Background: Treatment of PCOS
Place: Bushehr University of Medical Sciences
Methods: Fifteen PCOS patients will be enrolled with the above mentioned criteria as the recipient group , and 15 individuals eligible as the recipient group will be introduced. Then, necessary tests will be carried out in both groups. The stool sample is taken from the group and analyzed. The provided capsules will be administered. The patients will be followed up for a period of 6 months.
Participants/Inclusion and exclusion criteria
Group entry criteria:
PCOS patient's sister
Women aged 15-59 years old
Healthy person
Fertile with regular menstrual cycle
Should have normal BMI.
Six months of antibiotics free.
Group departure criteria:
Any digestive disease
Any chronic infectious disease
Having high-risk social behaviors
History of recent antibiotic consumption
consumption of allergen foods
Intervention groups
Criteria for entering the recipient group:
Women of reproductive age 15-35
menstural irregularity
hyperandrogenism
Ultrasound with polycystic ovary symptoms
Lack of other diseases
Secondary amenorrhea for more than 3 months
Non-smoker
No addiction
No liquor
Obesity
Departure criteria for the recipient group:
History of any digestive disease
Immune suppression
Partial or complete recovery of PCOS after medications
Allergy to various foods.
Chronic infectious diarrhea
Consumption of antibiotics 3 days before the transplant
Any malignancy
Inherited diseases
Cushing's disease
Acromegaly and gigantism
Diabetes
Main outcome variables
Removing PCOS symptoms
Removing irregular mensuration
Removal of secondary amenorrhea
Removing symptoms of hyperandrogenism
Removing hyperandrogenemia
Decreasing the relative obesity
General information
Reason for update
Acronym
پیوند میکروبیوم
IRCT registration information
IRCT registration number:IRCT20190523043674N1
Registration date:2019-07-10, 1398/04/19
Registration timing:registered_while_recruiting
Last update:2019-07-10, 1398/04/19
Update count:0
Registration date
2019-07-10, 1398/04/19
Registrant information
Name
Katayoun Vahdat
Name of organization / entity
The Persian Gulf Biomedical Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 77 3355 7755
Email address
k.vahdat@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Fecal microbiota transplantation (FMT) for treatment of polycystic ovary syndrome: a clinical trial phase I
Public title
Effect of fecal microbita transplantation in treatment of PCOS
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 15 years old to 35 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University/Regional Research Ethics Committee Bushehr province university of medical sciences
Street address
Bushehr University of Medical Sciences, Moallem St, Bushehr, Iran.
City
Busheher
Province
Boushehr
Postal code
7514633341
Approval date
2019-05-20, 1398/02/30
Ethics committee reference number
IR.BPUMS.REC.1398.042
Health conditions studied
1
Description of health condition studied
Poly-cystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Khalije Fars Hospital
Full name of responsible person
Katayoun Vahdat
Street address
Taleghani street
City
Bushehr
Province
Boushehr
Postal code
7517933755
Phone
+98 77 3345 5375
Fax
+98 77 3334 1828
Email
k.vahdat@bpums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Azam Amini
Street address
Moallem St, Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3334 1828
Email
foreign.chancellor@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Katayoun Vahdat
Position
Professor of Infectious Diseases
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Persian Gulf Biomedical Research Institute, Boostan 19 Alley, Postal Code: 7514763448, Imam Khomeini Street, Bushehr/I.R. Iran.
City
Boushehr
Province
Boushehr
Postal code
7514763448
Phone
+98 77 3334 1827
Email
k.vahdat@bpums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Katayoun Vahdat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
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.
City
Boushehr
Province
Boushehr
Postal code
7514763448
Phone
+98 77 3334 1827
Email
k.vahdat@bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Katayoun Vahdat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
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.
City
Boushehr
Province
Boushehr
Postal code
7514763448
Phone
+98 77 3334 1827
Email
k.vahdat@bpums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The whole potential data is publishable after being unidentifiable
When the data will become available and for how long
Start to access the data: 6 months after publishing the results
To whom data/document is available
Data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Contact the e-mail of scientific responsible person for project and obtain permission after providing data usage goals
From where data/document is obtainable
Dr Katayun Vahdat: vahdatk@gmail.com
Dr Amin Tamadon: amintamaddon@yahoo.com
What processes are involved for a request to access data/document
1- Review the data request: 1 month
2- Data delivery: 1 week