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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: 2024-05-05, 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.
Category
Treatment - Drugs

2

Description
Placebo group: Capsule containing magnesium stearate, maltodextrin (Tak Gene Zist, Iran). 1 capsules per day, Duration 4 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Mehri Salari
Street address
Shohadaye Tajrish Educational Hospital, Tajrish Square, Tehran Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
mehri.salari@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Yaman Ave., Shahid Chamran Exp., Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 9768
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehri Salari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Shohadaye Tajrish Hospital, Tajrish Square, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
mehri.salari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Taj Abadi Ebrahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
4th Floor, No. 214, East Nosrat St.,Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419735631
Phone
+98 21 5475 1000
Fax
Email
m.tajabadi@iauctb.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
shirin hajyani
Position
PhD student of Microbiology
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
4th Floor, No 214, East Nosrat St., Towhid Sq
City
Tehran
Province
Tehran
Postal code
1419735631
Phone
+98 21 5475 1000
Email
shirin.hajyani65@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
patient information in kept confidential and will not be published
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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