Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on hormonal profiles, inflammatory factors and oxidative stress biomarkers in women with polycystic ovary syndrome
Objective: The aim of this study is to determine the effects of combined probiotic and selenium supplementation on hormonal profiles, inflammatory factors and oxidative stress biomarkers in patients with polycystic ovary syndrome.
Design
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive combined probiotic and selenium supplement (n=30) or placebo (n=30).
Settings and conduct
Among patients with polycystic ovary syndrome referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate.
Intervention groups
Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and selenium supplements (Webber Naturals, Mississauga, Canada), 200 µg, daily, for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 12 weeks orally.
Main outcome variables
Outcomes: Total testosterone (primary outcome) and biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N22
Registration date:2017-12-18, 1396/09/27
Registration timing:registered_while_recruiting
Last update:2017-12-18, 1396/09/27
Update count:1
Registration date
2017-12-18, 1396/09/27
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-04, 1396/09/13
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on hormonal profiles, inflammatory factors and oxidative stress biomarkers in women with polycystic ovary syndrome
Public title
Effect of combined probiotic and selenium supplementation in treatment of patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with polycystic ovary syndrome.
Individuals aged 18 to 40 years.
Exclusion criteria:
Exclusion criteria: Unwillingness to cooperate.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y), subjects will be randomly divided into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
IR.ARAKMU.REC.1396.203
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Total testosterone
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
SHBG
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
3
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention