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IRCT20180818040827N2 IRCT 2021-03-16 Esfahan University of Medical Sciences The effect of synbiotic supplementation on Parkinson's disease Evaluation of the effect of synbiotic supplementation on antioxidant and inflammatory markers, serum zonulin level and quality of life in patients with Parkinson's disease 2021-04-12 anticipated 80 Complete https://irct.ir/trial/54058 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done by stratified Permuted Block Randomization, via the website, https://www.sealedenvelope.com/simple-randomiser/v1/lists. Each block has capacity for two subjects. Subjects will be stratified according to gender and age. After that, subjects will be randomly assigned to treatment or placebo groups, within each block. Researchers will not inform about the randomization process until completion of data analyses. Allocation concealment will be conducted by application of sealed envelopes containing treatment or placebo, created by a colleague that is not involved with data gathering and participant evaluation (concealment), Blinding description: This study is a randomized double-blind clinical trial. The synbiotic supplement and its placebo will be packed in the same boxes in terms of appearance (color, shape, smell, weight) and the researcher, patients, evaluators , those responsible for collecting data and data analyzer will not be informed of the contents of the packages until the end of the study. N/A Parkinson's disease. Intervention 1: Intervention group: They will receive 5 g/d of synbiotic supplement, Containing Lactobacillus, Bifidobacterium and Streptococcus species and Inulin prebiotic( product of Tak gen zist CO,Iran )and Proper diet for parkinson's disease for 12 weeks. Intervention 2: Control group: They will receive 5 g/d of maltodextrin and Proper diet for parkinson's disease 12 weeks. Yes - There is a plan to make this available What will be shared: Major part of information will be available for population. When: 12 months after publication To whom: Available for people working in academic institutions Conditions: To conduct similar studies Where to obtain: r_amani@nutr.mui.ac.ir How to obtain: The data will be sent as soon as possible, after receiving the request Comments:
public sanaz mehrabani
Hezarjarib street
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 1378 sanaz_mehr6500@yahoo.com Esfahan University of Medical Sciences scientific Reza Amani
Hezarjarib street
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 1378 r_amani@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients who agree to participate in the study Diagnosis of Parkinson's by a neurologist based on the diagnostic criteria of the Parkinson's Disease Association (UK Parkinson's disease society Brain Bank criteria) Age 50 to 80 years 50 years 80 years Both Regular consumption of products fortified with probiotics and prebiotics, probiotic and prebiotics supplements at least 2 months before start of the study Take antibiotics or laxatives at least 2 months before the start of the study Take antioxidant supplements or supplements that affect the disease Having a history of gastrointestinal surgery History of chronic gastrointestinal disease, hypothyroidism or hyperthyroidism, severe psychosis, or other concomitant neurological diseases, cognitive impairment, smoking or nicotine or alcohol use Having a history of type 1 and 2 diabetes Taking anti-inflammatory and immunosuppressive drugs Sensitivity to the compounds in the supplement Having hoehn and yahr score of 5 out of 5 G20 Parkinson's disease Treatment - Drugs Treatment - Drugs Intervention group: They will receive 5 g/d of synbiotic supplement, Containing Lactobacillus, Bifidobacterium and Streptococcus species and Inulin prebiotic( product of Tak gen zist CO,Iran )and Proper diet for parkinson's disease for 12 weeks Control group: They will receive 5 g/d of maltodextrin and Proper diet for parkinson's disease 12 weeks Symptome of Parkinson's disease (Motor and non motor). Timepoint: At baseline and after 12 weeks. Method of measurement: Using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) questionnaire and Calculate the score of the questions and use of them. Zonulin. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. High sensitive C-reactive protein (Hs-CRP). Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. TNF-α. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. Total antioxidant capacity. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co. Total oxidant status. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co. Malodialdehyde. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co. Glutathione. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co. Disease stage progression. Timepoint: At baseline and after 12 weeks. Method of measurement: Hoehn and yahr scale. Lipopolysaccharid (endotoxin). Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. Quality of life. Timepoint: at baseline and after 12 week. Method of measurement: Parkinson's Disease Questionnaire - 39. Dietary intake. Timepoint: at baseline, Week six and twelve. Method of measurement: food record. Depression and anxiety. Timepoint: At baseline and after 12 weeks. Method of measurement: beck depression questionnaire and hospital anxiety and depression scale. Fatigue. Timepoint: At baseline and after 12 weeks. Method of measurement: Fatigue severity scale questionnaire. Body mass index. Timepoint: At baseline and after 12 weeks. Method of measurement: It will calculated by weight divided by height (in meters). Weight. Timepoint: At baseline and after 12 weeks. Method of measurement: Standard weight scale. Esfahan University of Medical Sciences Approved 2020-07-22 Ethics committee of Isfahan University of Medical Sciences Hezarjarib Ave. Isfahan Isfehan Iran (Islamic Republic of)