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At baseline, and the 16 weeks after the intervention
Beginning of study and week 12
At baseline,Beginning of study and the 16 weeks after the interventionweek 12
ابتدای مطالعه و 16 هفته بعد از مداخله
ابتدای مطالعه و هفته 12
ابتدای مطالعه و 16 هفته بعد از مداخله12
ELISA
questionnaire
ELISAquestionnaire
الایزا
پرسشنامه
الایزاپرسشنامه
#4
Malondialdehyde (MDA)
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Malondialdehyde (MDA)
مالون دی آلدئید (MDA)
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مالون دی آلدئید (MDA)
At baseline, and the 16 weeks after the intervention
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At baseline, and the 16 weeks after the intervention
در ابتدای مطالعه و 16 هفته بعد از مداخله
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در ابتدای مطالعه و 16 هفته بعد از مداخله
Thiobarbituric acid assay
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Thiobarbituric acid assay
روش تیوباربیتوریک اسید
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روش تیوباربیتوریک اسید
#5
Total antioxidant capacity (TAC)
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Total antioxidant capacity (TAC)
ظرفیت تام آنتی اکسیدانی (TAC)
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ظرفیت تام آنتی اکسیدانی (TAC)
At baseline, and the 16 weeks after the intervention
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At baseline, and the 16 weeks after the intervention
در ابتدای مطالعه و 16 هفته بعد از مداخله
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در ابتدای مطالعه و 16 هفته بعد از مداخله
Colorimetric method
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Colorimetric method
روش رنگ سنجی
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روش رنگ سنجی
Secondary outcomes
#1
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Serum analyses (Level of IFN-γ, IL-1β, IL-6, IL-10, TNF-α, TAC and MDA)
Serum analyses (Level of IFN-γ, IL-1β, IL-6, IL-10, TNF-α, TAC and MDA)
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آنالیز سرم (سطح سایتوکائین ها)
آنالیز سرم (سطح سایتوکائین ها)
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At the beginning of the study and week 12
At the beginning of the study and week 12
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در ابتدای مطالعه و هفته 12
در ابتدای مطالعه و هفته 12
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ELISA
ELISA
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الایزا
الایزا
Protocol summary
Study aim
Effect of ingestion of Iranian native multi-strain probiotic Supplement on inflammatory and oxidative stress factors in Parkinson's disease patients
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Blood biomarkers including cytokines (TNF-α, IL-1β and IL-10) and oxidative stress (Malondialdehyde (MDA) and total antioxidant capacity (TAC).
General information
Reason for update
This clinical trial has a placebo.
Acronym
IRCT registration information
IRCT registration number:IRCT20200921048793N1
Registration date:2020-10-09, 1399/07/18
Registration timing:registered_while_recruiting
Last update:2024-03-10, 1402/12/20
Update count:3
Registration date
2020-10-09, 1399/07/18
Registrant information
Name
maryam Taj Abadi Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5475 1000
Email address
m.tajabadi@iauctb.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ingestion of Iranian native multi-strain probiotic Supplement on inflammatory and oxidative stress factors in Parkinson's disease patients
Public title
Effect of probiotic in Parkinson's disease patients
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, main investigators, doctors, data collectors and people who evaluate the outcome
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Public Health and Neuroscience Research Center, Shahid Beheshti Univer
Street address
School of Public Health and Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Yaman Ave., Shahid Chamran Exp., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-08-19, 1399/05/29
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.136
Health conditions studied
1
Description of health condition studied
parkinson
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
The Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint
Beginning of study and week 12
Method of measurement
questionnaire
2
Description
Beck Anxiety Inventory (BAI)
Timepoint
Beginning of study and week 12
Method of measurement
questionnaire
3
Description
Unified Parkinson's Disease Rating Scale (UPDRS)
Timepoint
Beginning of study and week 12
Method of measurement
questionnaire
Secondary outcomes
1
Description
Serum analyses (Level of IFN-γ, IL-1β, IL-6, IL-10, TNF-α, TAC and MDA)
Timepoint
At the beginning of the study and week 12
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: : probiotic capsule (Takgene 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 4×109 cfu ⁄capsule. 1 capsules per day, Duration 4 months.