Study the effects of probiotic supplementation on metabolic parameters and level of androgens in women with polycystic ovary syndrome: a randomized double-blind, clinical trial
Study the effects of probiotic supplementation on metabolic parameters and level of androgens in women with polycystic ovary syndrome: a randomized double-blind, clinical trial
Design
a randomized double-blind, clinical trial
Settings and conduct
This study was a double blind randomized clinical trial Which will be performed on 84 patients with polycystic ovary syndrome in the age range of 18-45 years.
Patients will be randomly divided into two groups. The first group will receive probiotics (Saccharomyces boulardii) and the second group of placebo. The duration of the study will be 3 months
In each case, a fasting blood sample will be taken from all patients before and after intervention. The levels of FBS, DHEAS sulfate and testosterone will be measured.
Stata software will be used to analyze the data.
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients whom have polycystic ovary syndrome based on the ultrasond tests; Exclusion criteria:hypertension, hyperprolactinemia, Renal failure, liver failure, heart failure, cushings syndrome, hyperthyroidism, hypothyroidism, cancer, smoking, diabetes, autoimmune disease
Intervention groups
the case group will receive 1 probiotic capsule daily for 3 months
The control group will receive 1 plasebo capsule daily for 3 months
Study the effects of probiotic supplementation on metabolic parameters and level of androgens in women with polycystic ovary syndrome: a randomized double-blind, clinical trial
Public title
Study the effects of probiotic supplementation on polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients whom have polycystic ovary syndrome based on the ultrasond tests
Arrangement of the randomization process:
1) Determining the volume of each block (quadruple blocks)
2) Preparing the list of the blocks and assigning a number to each of them
AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6)
3) Choosing random numbers between 1 and 6
4) Defining the treatment assignment list
For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5)
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants (patients) and the researcher who has the task of sampling in the study, and the analyser are all blind during the study. At the patient's level, blindness will be done using a placebo, in which it will be given the probiotic to a group and placebo to another group, and patients will not be informed that they received a probiotic capsule or a placebo capsule that looks completely identical. The researcher will give patients a medicine or placebo only on the basis of lableA or B without knowing the nature of A, B, and according to the randomized list.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-10-08, 1397/07/16
Ethics committee reference number
IR.TBZMED.REC.1397.599
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Fasting blood sugar level
Timepoint
At the beginning and 3 months later
Method of measurement
laboratory tests(enzymatic)
2
Description
testestrone
Timepoint
At the beginning and 3 months later
Method of measurement
laboratory tests(immuno assay)
3
Description
Dehydroepiandrosterone sulfate
Timepoint
At the beginning and 3 months later
Method of measurement
laboratory tests(immuno assay)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:daily administration of 1 probiotic capsule "DAILYEAST" for 3 months(a product of zist takhmir company)
Category
Treatment - Drugs
2
Description
Control group:daily administration of 1 plasebo capsule "DAILYEAST" for 3 months(a product of zist takhmir company)