Protocol summary
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Study aim
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The aim of this study is to determine the effects of probiotic supplementation on hormonal profiles and biomarkers of oxidative stress in patients with polycystic ovary syndrome.
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Design
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Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
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Settings and conduct
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Population and sample size: Among patients with polycystic ovary syndrome referred to Akbarabadi Clinic affiliated to Iran University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18 to 40 years will be included in this study. Exclusion criteria: Smokers, taking probiotic supplements, pregnant women, endocrine diseases including thyroid, diabetes and/or impaired glucose tolerance
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Intervention groups
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Intervention: Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30) per day. Probiotic and placebos capsules are similar in shape and size.
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Main outcome variables
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Outcomes: Hs-CRP (primary outcome) and nitric oxide (NO), biomarkers of oxidative stress and hormonal profile (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201704235623N112
Registration date:
2017-04-27, 1396/02/07
Registration timing:
retrospective
Last update:
2019-09-23, 1398/07/01
Update count:
1
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Registration date
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2017-04-27, 1396/02/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Iran University of Medical Sciences
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Expected recruitment start date
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2017-02-28, 1395/12/10
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Expected recruitment end date
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2017-03-30, 1396/01/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of the effect of probiotic supplementation compared with the placebo on profiles of metabolic in women with polycystic ovary syndrome
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Public title
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Effect of supplementation in treatment of women with polycystic ovary syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with PCOS according to Rotterdam criteria
Aged 18 to 40 years
Obtaining informed consent
Exclusion criteria:
Smokers
Taking probiotic supplements
Pregnant women
Endocrine diseases including thyroid, diabetes and/or impaired glucose tolerance.
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-02-27, 1395/12/09
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Ethics committee reference number
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IR.IUMS.REC.1395.8823215264
Health conditions studied
1
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Description of health condition studied
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Polycystic ovarian syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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hs-CRP
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
Secondary outcomes
1
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
2
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
3
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
4
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
5
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Description
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Total testosterone
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
6
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Description
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SHBG
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
7
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Description
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DHEAS
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
8
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Description
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Hirsutism
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Clinical observation
Intervention groups
1
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Description
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Intervention group: Probiotic capsule containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g) (Tak Gen Zist, Tehran, Iran), daily, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 12 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available