]>
IRCT20210513051277N1 IRCT 2021-05-27 Tehran University of Medical Sciences The effect of probiotic supplementation on cognitive function in Alzheimer's patients The effect of probiotic supplementation on cognitive, inflammation and oxidative stress in adults with Alzheimer disease: A randomized, double blind, placebo-controlled trial 2021-06-22 anticipated 30 Complete https://irct.ir/trial/56379 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Stratified permute block randomization will be performed in two categories based on (age and sex) using the site www.randomization.com. In this method, each group is assigned one of the letters A, B and C and randomization will be done in 6 blocks. This is done for both age groups and two lists are prepared based on age and gender. Within each class, patients will be randomly assigned to one of the three study groups in a 1: 1: 1 ratio, Blinding description: All supplements will be provided by Lallemand Canada and are similar in color, taste and size. Supplements are coded by the company, and researchers, participants, data collectors and analysts, and the Data Safety and Supervision Committee are unaware of which group receives which supplement. 3 Alzheimer disease. Intervention 1: Intervention group: Patients in the first group will receive 2 probiotic capsules daily containing 1 bacterial strain of Lactobacillus rhamnosus HA-114 in the amount of CFU 1015. All supplements will be provided by Lallemand Canada and are similar in color, taste and size. Take 2 capsules daily, one after lunch and one after dinner. Supplements will be delivered to patients in two stages (study start and week 6). Intervention 2: Intervention group: Patients in the second group will receive 2 probiotic capsules daily containing 1 bacterial strain of Bifidobacterium longum R0175 in the amount of CFU 1015. All supplements will be provided by Lallemand Canada and are similar in color, taste and size. Take 2 capsules daily, one after lunch and one after dinner. Supplements will be delivered to patients in two stages (study start and week 6). Intervention 3: Control group: Patients in the intervention group will receive 2 placebo capsules daily containing xylitol, maltodextrin and malic acid. All supplements will be provided by Lallemand Canada and are similar in color, taste and size. Take 2 capsules daily, one after lunch and one after dinner. Supplements will be delivered to patients in two stages (study start and week 6). 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 There is no more information.
public Camellia Akhgarjand
Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1417653911 +98 21 8895 5975 kameliaakhgarjand@yahoo.com Tehran University of Medical Sciences scientific Kurosh Djafarian
Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1417653911 +98 21 8895 5975 kdjafarian@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 80-50 years Resident of Tehran Diagnosis of Alzheimer's disease according to NINCDS-ARDA criteria maximum in the last 2 years BMI=18/5-30 Kg/m2 Use of acetylcholinesterase inhibitors (AchEIs) and N-methyl dispartate (NMDA) receptor antagonists caregivers understands the objectives of the study and agrees to follow the necessary rules throughout the study 50 years 80 years Both Having frontotemporal dementia, Levy Buddy dementia, Parkinson's disease dementia and any type of severe dementia Take antibiotics at least three months before enrollment Smoking (at least 5 cigarettes a day for the past 6 months) and other tobacco (pipe and hookah at least once a month Any drug addiction Follow a specific diet for three months before the study People who participated in another study less than two months ago. Take any amount of supplements or foods fortified with fins or probiotics during the last 3 months History of serious kidney, liver, intestinal, endocrine diseases, cardiovascular, gastrointestinal, pulmonary, blood and metabolic diseases, thyroid, rheumatoid arthritis and lupus History of major gastrointestinal surgeries including gastrectomy, bowel restriction, etc. G30 Alzheimer's disease Other Other Placebo Intervention group: Patients in the first group will receive 2 probiotic capsules daily containing 1 bacterial strain of Lactobacillus rhamnosus HA-114 in the amount of CFU 1015. All supplements will be provided by Lallemand Canada and are similar in color, taste and size. Take 2 capsules daily, one after lunch and one after dinner. Supplements will be delivered to patients in two stages (study start and week 6). Intervention group: Patients in the second group will receive 2 probiotic capsules daily containing 1 bacterial strain of Bifidobacterium longum R0175 in the amount of CFU 1015. All supplements will be provided by Lallemand Canada and are similar in color, taste and size. Take 2 capsules daily, one after lunch and one after dinner. Supplements will be delivered to patients in two stages (study start and week 6). Control group: Patients in the intervention group will receive 2 placebo capsules daily containing xylitol, maltodextrin and malic acid. All supplements will be provided by Lallemand Canada and are similar in color, taste and size. Take 2 capsules daily, one after lunch and one after dinner. Supplements will be delivered to patients in two stages (study start and week 6). Cognitive function. Timepoint: Measurement of cognitive function at the beginning of the intervention (before the start of the intervention) and the end of week 12. Method of measurement: Mini–Mental State Examination questionnaire. Serum level of IL-6. Timepoint: at the beginning of the intervention (before the start of the intervention) and the end of week 12. Method of measurement: Double Antibody Sandwich. Serum level of interleukin-10. Timepoint: at the beginning of the intervention (before the start of the intervention) and the end of week 12. Method of measurement: enzyme-linked immunosorbent assay. Serum level 0f TNF-α. Timepoint: at the beginning of the intervention (before the start of the intervention) and the end of week 12. Method of measurement: Quantitative Sandwich. Serum level of 8-hydroxy-2' -deoxyguanosine (8-OHdG). Timepoint: at the beginning of the intervention (before the start of the intervention) and the end of week 12. Method of measurement: Double Antibody Sandwich. Serum levels of malondialdehyde (MDA). Timepoint: at the beginning of the intervention (before the start of the intervention) and the end of week 12. Method of measurement: Colorimetric. Serum level of glutathione. Timepoint: at the beginning of the intervention (before the start of the intervention) and the end of week 12. Method of measurement: Quantitative Sandwich. Serum kynurenine levels. Timepoint: at the beginning of the intervention (before the start of the intervention) and the end of week 12. Method of measurement: Quantitative Sandwich. Serum tryptophan levels. Timepoint: at the beginning of the intervention (before the start of the intervention) and the end of week 12. Method of measurement: Fluorometric. Serum levels of lipopolysaccharide. Timepoint: at the beginning of the intervention (before the start of the intervention) and the end of week 12. Method of measurement: quantitative sandwich enzyme immunoassay. Physical activity. Timepoint: at the beginning of the intervention (before the start of the intervention) and the end of week 12. Method of measurement: questionnaire. Quality of Life. Timepoint: at the beginning of the intervention (before the start of the intervention) and the end of week 12. Method of measurement: Quality of life in Alzheimer disease questionnaire (QOL-AD). Tehran University of Medical Sciences Approved 2021-05-15 Ethics Committee of Tehran University of Medical Sciences Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)