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 disease severity and metabolic profiles in patients with Parkinson's.
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Design
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Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30).
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Settings and conduct
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60 eligible patients with Parkinson's and referred to Shahid Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected for the study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with Parkinson's and aged 50 to 90 years will be included in this study. Exclusion criteria were were taking antioxidants supplements and anti-inflammatory medications, depression and severe psychosis, hypo- and hyperthyroidism, smoking and unwillingness to cooperate.
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Intervention groups
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Intervention group: Probiotic 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) (Zisttakhmir Company, Tehran, Iran) daily, for 12 weeks orally.
Control group: Placebo (Barij Essence, Kashan, Iran) daily for 12 weeks orally
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Main outcome variables
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Unified Parkinson's disease rating scale (UPDRS) and high sensitivity C-reactive protein (primary outcomes), fasting plasma glucose, insulin, insulin resistance, lipid profiles and oxidative stress (secondary outcomes)
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:
IRCT2017082434497N4
Registration date:
2017-09-06, 1396/06/15
Registration timing:
registered_while_recruiting
Last update:
2019-09-11, 1398/06/20
Update count:
1
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Registration date
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2017-09-06, 1396/06/15
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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, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-08-17, 1396/05/26
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Expected recruitment end date
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2017-09-17, 1396/06/26
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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 metabolic profiles in patients with Parkinson's
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Public title
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Effect of supplementation in treatment of patients with Parkinson's
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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 Parkinson's
Aged 50 to 90 years
Exclusion criteria:
Taking antioxidants supplements
Taking anti-inflammatory supplements
Depression
Severe psychosis
hypo- and hyperthyroidism
Smoking
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Age
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From 50 years old to 90 years old
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Gender
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Both
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Phase
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2
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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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Participants in each block will be randomly allocated into two treatment groups to take either probiotic supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups. https://stattrek.com/statistics/random-number-generator.aspx
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
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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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2017-08-16, 1396/05/25
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Ethics committee reference number
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IR.Kaums.MEDNT.REC.1396.29
Health conditions studied
1
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Description of health condition studied
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Parkinson 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 disease
Primary outcomes
1
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Description
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high sensitivity C-reactive protein (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
2
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Description
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Unified Parkinson's disease rating scale
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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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Physical Examination by Neurologist
Secondary outcomes
1
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Description
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Insulin
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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
2
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Description
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Triglycerides
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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
3
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Description
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Total cholesterol
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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
4
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Description
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HDL-cholesterol
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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
5
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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
6
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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
7
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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
8
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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
9
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Description
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Insulin resistance
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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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Calculation using HOMA formula
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) (Zisttakhmir Company, 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 Pharmaceutical Company, 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, Kashan 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