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IRCT20200921048793N1 IRCT 2020-10-09 Shahid Beheshti University of Medical Sciences Effect of probiotic in Parkinson's disease patients Effect of ingestion of Iranian native multi-strain probiotic Supplement on inflammatory and oxidative stress factors in Parkinson's disease patients 2020-08-22 anticipated 30 Complete https://irct.ir/trial/51104 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 description: Participants, main investigators, doctors, data collectors and people who evaluate the outcome. 3 parkinson. Intervention 1: 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 2: Placebo group: Capsule containing magnesium stearate, maltodextrin (Tak Gene Zist, Iran). 1 capsules per day, Duration 4 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is patient information in kept confidential and will not be published
public Mehri Salari
Shohadaye Tajrish Hospital, Tajrish Square, Tehran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 mehri.salari@gmail.com Shahid Beheshti University of Medical Sciences scientific Maryam Taj Abadi Ebrahimi
4th Floor, No. 214, East Nosrat St.,Towhid Sq.
Tehran Iran (Islamic Republic of) 1419735631 +98 21 5475 1000 m.tajabadi@iauctb.ac.ir Islamic Azad University Iran (Islamic Republic of) 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 18 years 80 years Both 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 G20 Parkinson's disease Treatment - Drugs Placebo 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. Placebo group: Capsule containing magnesium stearate, maltodextrin (Tak Gene Zist, Iran). 1 capsules per day, Duration 4 months. 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. Shahid Beheshti University of Medical Sciences Approved 2020-08-19 Ethics committee of School of Public Health and Neuroscience Research Center, Shahid Beheshti Univer School of Public Health and Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Yaman Ave., Shahid Chamran Exp., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)