Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Primary outcomes
#1
The Gastrointestinal Symptom Rating Scale (GSRS)
Analyses Level of TNF-α, IL-1β, IL-10, Malondialdehyde (MDA), Total antioxidant capacity (TAC)
The Gastrointestinal Symptom Rating ScaleAnalyses Level of TNF-α, IL-1β, IL-10, Malondialdehyde (GSRSMDA), Total antioxidant capacity (TAC)
مقیاس امتیازدهی علائم گوارشی
آنالیز سطح سایتوکائین ها (TNF-α, IL-1β, IL-10, Malondialdehyde (MDA), Total antioxidant capacity (TAC))
مقیاس امتیازدهی علائم گوارشیآنالیز سطح سایتوکائین ها (TNF-α, IL-1β, IL-10, Malondialdehyde (MDA), Total antioxidant capacity (TAC))
Beginning of study and week 12
At the beginning of the study and week 12
BeginningAt the beginning of the study and week 12
ابتدای مطالعه و هفته 12
در ابتدای مطالعه و هفته 12
در ابتدای مطالعه و هفته 12
questionnaire
ELISA
questionnaireELISA
پرسشنامه
الایزا
پرسشنامهالایزا
#2
Beck Anxiety Inventory (BAI)
empty
Beck Anxiety Inventory (BAI)
اندازه‌گیری اضطراب بک
empty
اندازه‌گیری اضطراب بک
Beginning of study and week 12
empty
Beginning of study and week 12
ابتدای مطالعه و هفته 12
empty
ابتدای مطالعه و هفته 12
questionnaire
empty
questionnaire
پرسشنامه
empty
پرسشنامه
#3
Unified Parkinson's Disease Rating Scale (UPDRS)
empty
Unified Parkinson's Disease Rating Scale (UPDRS)
مقیاس امتیازدهی یکپارچه بیماری پارکینسون
empty
مقیاس امتیازدهی یکپارچه بیماری پارکینسون
Beginning of study and week 12
empty
Beginning of study and week 12
ابتدای مطالعه و هفته 12
empty
ابتدای مطالعه و هفته 12
questionnaire
empty
questionnaire
پرسشنامه
empty
پرسشنامه
Secondary outcomes
#1
Serum analyses (Level of IFN-γ, IL-1β, IL-6, IL-10, TNF-α, TAC and MDA)
empty
Serum analyses (Level of IFN-γ, IL-1β, IL-6, IL-10, TNF-α, TAC and MDA)
آنالیز سرم (سطح سایتوکائین ها)
empty
آنالیز سرم (سطح سایتوکائین ها)
At the beginning of the study and week 12
empty
At the beginning of the study and week 12
در ابتدای مطالعه و هفته 12
empty
در ابتدای مطالعه و هفته 12
ELISA
empty
ELISA
الایزا
empty
الایزا
Intervention groups
#1
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.
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.
Intervention group: : probiotic capsule (Takgene zist 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 4×10910^9 cfu ⁄capsule. 1 capsules per day, Duration 4 months.
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:2024-05-05, 1403/02/16
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
empty
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
empty
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
Analyses Level of TNF-α, IL-1β, IL-10, Malondialdehyde (MDA), Total antioxidant capacity (TAC)
Timepoint
At the beginning of the study and week 12
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
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.