Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of probiotic supplementation on gene expression related to inflammation, insulin and lipid in patients with Parkinson's disease.
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Design
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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 probiotic supplement (n=25) or placebo (n=25).
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Settings and conduct
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Among patients with Parkinson's disease referred to Neurology Clinic, 50 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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with Parkinson' disease; aged 50 to 80 years. Exclusion criteria: Taking probiotics and/or synbiotics supplements, taking antioxidants supplements and anti-inflammatory agents, had depression and had severe psychosis, hypothyroidism, hyperthyroidism, and smokers.
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Intervention groups
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Intervention group: Probiotic oral capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus reuteri (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and Lactobacillus fermentum (2×109 CFU/g), daily, for 12 weeks. Control group: Placebo oral capsule (Barij Essence, Kashan, Iran) , daily, for 12 weeks.
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Main outcome variables
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Outcomes: Gene expression related to inflammation (primary outcomes) and inflammatory factors, markers of oxidative stress and gene expression related to insulin and lipid (secondary outcomes) 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:
IRCT20170513033941N34
Registration date:
2018-06-14, 1397/03/24
Registration timing:
retrospective
Last update:
2019-09-14, 1398/06/23
Update count:
1
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Registration date
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2018-06-14, 1397/03/24
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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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Expected recruitment start date
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2017-10-16, 1396/07/24
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Expected recruitment end date
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2017-10-31, 1396/08/09
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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 gene expression related to inflammation, insulin and lipid in patients with Parkinson's disease
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Public title
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Effect of probiotic supplementation in treatment of patients with Parkinson's disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: Patients with Parkinson' disease.
Individuals aged 50 to 80 years.
Exclusion criteria:
Taking probiotics and/or synbiotics supplements
Taking antioxidants supplements and anti-inflammatory agents
Had depression
Had severe psychosis
Hypothyroidism
Hyperthyroidism
Smokers
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Age
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From 50 years old to 80 years old
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Gender
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Both
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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:
50
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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 receive supplement or placebo. 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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2017-10-15, 1396/07/23
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Ethics committee reference number
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IR.IAU.SRB.REC.1396.72
Health conditions studied
1
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Description of health condition studied
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Parkinson's disease
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ICD-10 code
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G20
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ICD-10 code description
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Parkinson's disease
Primary outcomes
1
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Description
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Expressed levels of TNF-a gene
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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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PCR
2
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Description
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Expressed levels of IL-1 gene
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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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PCR
3
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Description
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Expressed levels of IL-8 gene
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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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PCR
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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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
3
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Description
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Expressed levels of PPAR-γ gene
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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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PCR
4
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Description
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Expressed levels of LDLR gene
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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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PCR
5
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Description
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Expressed levels of VEGF gene
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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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PCR
6
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Description
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Expressed levels of TGF-β gene
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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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PCR
Intervention groups
1
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Description
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Intervention group: Probiotic oral capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus reuteri (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and Lactobacillus fermentum (2×109 CFU/g), daily, for 12 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo oral capsule (Barij Essence, Kashan, Iran) , daily, for 12 weeks
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Category
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Placebo
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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Islamic Azad University
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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