Protocol summary
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Study aim
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The aim of the current study is to evaluate the effects of synbiotic supplementation on metabolic profiles and biomarkers of oxidative stress in women with polycystic ovary syndrome (PCOS).
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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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60 patients with PCOS among women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18–40 years old will be included in this study. Exclusion criteria: Smokers, taking probiotic and/or synbiotic supplements, pregnant women, endocrine diseases including thyroid, diabetes and/or impaired glucose tolerance, gastrointestinal problems.
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Intervention groups
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Patients will be assigned to receive either synbiotic supplements (intervention group: n=30) or placebo (control group: n=30).
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Main outcome variables
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Outcomes: Hormonal profiles (primary outcomes) and biomarkers of oxidative stress and hormonal (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:
IRCT201509115623N53
Registration date:
2015-09-27, 1394/07/05
Registration timing:
prospective
Last update:
2019-09-26, 1398/07/04
Update count:
2
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Registration date
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2015-09-27, 1394/07/05
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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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Arak University of Medical Sciences
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Expected recruitment start date
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2016-01-01, 1394/10/11
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Expected recruitment end date
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2016-03-15, 1394/12/25
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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 synbiotic supplementation compared with the placebo on metabolic profiles and biomarkers of oxidative stress 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:
Women aged 18-40 years
Diagnosed with PCOS
Exclusion criteria:
Smokers
Taking probiotic and/or synbiotic supplements
Pregnant women
Endocrine diseases including thyroid, diabetes and/or impaired glucose tolerance
Gastrointestinal problems
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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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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take synbiotic supplements (n = 30) or placebo (n = 30). 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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2015-08-23, 1394/06/01
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Ethics committee reference number
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IR.ARAKMU.REC.1394.160
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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Fasting blood sugar
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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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Enzymatic kit
2
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Description
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Serum dehydroepiandrosterone
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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
3
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Description
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Serum 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
4
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Description
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Plasma 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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Plasma 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
6
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Description
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Plasma 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
7
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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
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: Synbiotic capsule, Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g) plus 0.8 g inulin, 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 capsule, 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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Arak 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Not
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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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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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable