Protocol summary

Summary
Polycystic ovarian syndrome includes a series of metabolic disorders including insulin resistance and sexual hormonal disorders. Some studies point to the fact that imbalance in intestinal bacteria increases the immune response followed by inflammation and then disrupts insulin receptors and occur insulin resistance. this leading insulin resistance, increased androgens, and follicular growth. So, supplementation with synbiotics seems to help the healthy environment of the intestine. In this study, 80 women aged 18 to 45 years old, according to the inclusion criteria, were randomly divided into two groups receiving daily synbiotic capsules for 8 weeks and the placebo group. The study was three-blind and the study variables included fasting glucose, fasting insulin, HOMA-I, IGF-1, AMH, LH, FSH, intestinal flora changes, and ultrasonography of ovarian cysts at the beginning and the end of the study In both groups, measurements are measured and then compared with each other. Also, the 24-hour food recall and physical activity questionnaire is measured at first, 4th and 8th week,to evaluate feed intake.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050233767N1
Registration date: 2017-09-22, 1396/06/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-22, 1396/06/31
Registrant information
Name
maryam aghayan
Name of organization / entity
Qazvin University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2631 8035
Email address
maryam.aghayan9@gmail.com
Recruitment status
Recruitment complete
Funding source
Qazvin university of medical sciences
Expected recruitment start date
2017-08-22, 1396/05/31
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of synbiotic on insulin resistance, gut microbiota, sex hormones and morphology of ovaries’ cysts in women with poly cystic ovarian syndrome
Public title
the effect of synbiotic supplementation on poly cystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: The willingness to collaborate in the plan, being between the ages of 18 and 45, has at least two criteria of Rotterdam's three criteria for detecting the syndrome and having a BMI of between 25 and 35 kg / m². exclusion criteria: Unwillingness to continue to participate in the study, inadequate supplementation (less than 80% of supplements), and the achievement of any non-inclusion criteria including pregnancy, lactation, menopause, drug use during the past three months include contraceptives, glucocorticoid, Lipid-lowering drugs, Weight loss drugs, Ovulation induction drugs, Estrogenic or anti-androgenic drugs, Underlying illnesses, Infectious diseases, Inflammatory disease, Adrenal gland abnormal, Cushing's syndrome, Adrenal gland tumor, Low Hyperthyroidism, Prolactinemia, Acromegaly, Diabetes and Cancer, Hormone Therapy over 3 months Past and use of probiotic, prebiotic and synbiotic supplements over the past 3 months
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
qazvin university of medical sciences
Street address
Shahid Bahonar blv, qazvin university of medical sciences
City
qazvin
Postal code
3419759811
Approval date
2017-02-27, 1395/12/09
Ethics committee reference number
IR.QUMS.REC.1395.295

Health conditions studied

1

Description of health condition studied
poly cystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
ovarian dysfunction

Primary outcomes

1

Description
sex hormones
Timepoint
at first/ end of study
Method of measurement
elisa

Secondary outcomes

1

Description
serum insulin
Timepoint
at first/ end of study
Method of measurement
elisa

Intervention groups

1

Description
intervention group: 1 capsule ( 500 mg of synbiotic supplementation)/ daily/ 2 months
Category
Treatment - Drugs

2

Description
control group: 1 placebo supplementation/ daily/ 2 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
kosar medical center
Full name of responsible person
Hamideh Pakniyat
Street address
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
research deputy , Qazvin university of medical sciences
Full name of responsible person
Maryam Javadi
Street address
Shahid Bahonar Blv, Qazvin university of medical sciences
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research deputy , Qazvin university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Health school, Qazvin university of medical sciences
Full name of responsible person
Maryam Aghayan
Position
master of science in nutrition
Other areas of specialty/work
Street address
Shahid Bahonar Blv, Qazvin university of medical sciences
City
Qazvin
Postal code
Phone
+98 28333360013750
Fax
Email
maryam.aghayan9@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Health school, Qazvin university of medical sciences
Full name of responsible person
Maryam Javadi
Position
PhD in nutritional sciences
Other areas of specialty/work
Street address
Shahid Bahonar Blv, Qazvin university of medical sciences
City
Qazvin
Postal code
Phone
+98 28333360013750
Fax
Email
mjavadi@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Health school, Qazvin university of medical sciences
Full name of responsible person
Maryam Aghayan
Position
Master of science in nutrition
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
maryam.aghayan9@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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