Protocol summary
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Study aim
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Effect of ingestion of Iranian native multi-strain probiotic Supplement on inflammatory and oxidative stress factors in Parkinson's disease patients
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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. 30 patients with parkinson of eligible in the study will be selected. Patients will be assigned to receive either probiotic supplements and control.
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Settings and conduct
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A total of 30 parkinson patients will be participated in this controlled double-blind trial. Subjects will be received either multispecies probiotic or placebo supplementation daily during a 16 weeks period. Blood samples will be collected from patients at the baseline and end of the study. Fecal microflora, plasma levels of TNF-α, IL-1β and IL-10, serum levels of MDA and TAC are assessed.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age over 18 and under 80, Diagnosis of idiopathic Parkinson's disease based on UK PD Society Brain Bank criteria, Using l-dopa or dopaminergic agonist. Exclusion criteria: Use antibiotics and commercial probiotics, Major surgery of the GI tract, History of active uncontrolled gastrointestinal disorders or diseases, Age over 80.
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Intervention groups
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Intervention group: : probiotic capsule (Takgene zist,Iran) containing L. rhamnosus, L. plantarum, L. acidophilus, L. salivarius, B. coagulans, B. longum and vitamin D3 (400IU). . Each capsule containing 10×4 cfu ⁄capsule. placebo group:placebo capsule (Takgene zist,Iran) containing magnesium stearate, lactose . Each capsule containing 10×4 cfu ⁄capsule.
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Main outcome variables
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Blood biomarkers including cytokines (TNF-α, IL-1β and IL-10) and oxidative stress (Malondialdehyde (MDA) and total antioxidant capacity (TAC).
General information
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Reason for update
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This clinical trial has a placebo.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200921048793N1
Registration date:
2020-10-09, 1399/07/18
Registration timing:
registered_while_recruiting
Last update:
2024-05-05, 1403/02/16
Update count:
3
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Registration date
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2020-10-09, 1399/07/18
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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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2020-08-22, 1399/06/01
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Expected recruitment end date
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2020-10-22, 1399/08/01
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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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Effect of ingestion of Iranian native multi-strain probiotic Supplement on inflammatory and oxidative stress factors in Parkinson's disease patients
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Public title
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Effect of probiotic in Parkinson's disease patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age over 18 and under 80
Diagnosis of idiopathic Parkinson's disease based on UK PD Society Brain Bank criteria
Using l-dopa or dopaminergic agonist
Exclusion criteria:
Use of systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral)
Use of commercial probiotics: includes tablets, capsules.
Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years
History of active uncontrolled gastrointestinal disorders or diseases including: inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis
Infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated)
Age over 80
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Age
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From 18 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
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
30
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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 occur centrally using an phone randomization system by an independent researcher. There are two treatment
arms.Randomization in the mentioned groups will be conducted according to permuted block randomization based on basis of 4 and 6 blocks.
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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, main investigators, doctors, data collectors and people who evaluate the outcome
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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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2020-08-19, 1399/05/29
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1399.136
Health conditions studied
1
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Description of health condition studied
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parkinson
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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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Analyses Level of TNF-α, IL-1β, IL-10, Malondialdehyde (MDA), Total antioxidant capacity (TAC)
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Timepoint
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At the beginning of the study and week 12
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Method of measurement
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ELISA
Intervention groups
1
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Description
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Intervention group: probiotic capsule (Tak Gene Zist, Iran) containing L. rhamnosus, L. plantarum, L. acidophilus, L. salivarius, B. coagulans, B. longum ,vitamin D3 (400IU), magnesium stearate, and maltodextrin . Each capsule containing 4×10^9 cfu ⁄capsule. 1 capsules per day, Duration 4 months.
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Category
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Treatment - Drugs
2
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Description
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Placebo group: Capsule containing magnesium stearate, maltodextrin (Tak Gene Zist, Iran). 1 capsules per day, Duration 4 months.
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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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Shahid Beheshti 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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patient information in kept confidential and will not be published
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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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No - There is not 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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No - There is not a plan to make this available