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IRCT2017082434497N4 IRCT 2017-09-06 Vice chancellor for research, Kashan University of Medical Sciences Effect of supplementation in treatment of patients with Parkinson's Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in patients with Parkinson's 2017-08-17 anticipated 60 Complete https://irct.ir/trial/26352 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in each block will be randomly allocated into two treatment groups to take either probiotic supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups. https://stattrek.com/statistics/random-number-generator.aspx, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded. 2 Parkinson disease. Intervention 1: Intervention group: Probiotic oral capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus reuteri (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and Lactobacillus fermentum (2×109 CFU/g) (Zisttakhmir Company, Tehran, Iran), daily, for 12 weeks orally. Intervention 2: Control group: Placebo (Barij Essence Pharmaceutical Company, Kashan, Iran), daily, for 12 weeks orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with Parkinson's Aged 50 to 90 years 50 years 90 years Both Taking antioxidants supplements Taking anti-inflammatory supplements Depression Severe psychosis hypo- and hyperthyroidism Smoking G20 Parkinson disease Treatment - Drugs Treatment - Drugs Intervention group: Probiotic oral capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus reuteri (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and Lactobacillus fermentum (2×109 CFU/g) (Zisttakhmir Company, Tehran, Iran), daily, for 12 weeks orally. Control group: Placebo (Barij Essence Pharmaceutical Company, Kashan, Iran), daily, for 12 weeks orally. High sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Unified Parkinson's disease rating scale. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Physical Examination by Neurologist. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula. Vice chancellor for research, Kashan University of Medical Sciences Approved 2017-08-16 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)