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IRCT20191008045024N1 IRCT 2019-12-28 Tehran University of Medical Sciences Effect of Probiotics Supplementation on Cognitive Status, Daily Life Function and Metabolic Indexes Effect of oral probiotic supplements on cognitive status, activity of daily living (ADL) and metabolic index in demented elderly: A randomized, double-blind, placebo-controlled trial 2019-10-23 anticipated 68 Complete https://irct.ir/trial/42822 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups, case and control groups, using permuted block randomization. We use the website http:/ /www.sealedenvelope.com for creation a random sequence in block randomization approach. It also advocates at specific sure to hide the allocation concealment. A number (specific code) is defined for each drug box according to the random sequence created. Based on the order of participant’s entrance to the study and the random number, each patient is divided into case or control group and receives probiotics supplementation or placebo, respectively, Blinding description: A member of the research team who is blind about the content of capsules and the group of every individual, gives each patient 60 capsules monthly, up to 3 months. Participants are requested to take two capsules each day. Patients in intervention group receive probiotic containing capsules and in control group, they receive placebo, which are exactly similar in appearance (including shape, size and color) and indistinguishable from probiotic containing capsules. 3 Condition 1: Dementia. Condition 2: Alzheimer's disease. Intervention 1: Intervention group: 68 patients receive 60 probiotic capsules (2 capsules daily for one month) and this continues for three months. Each probiotic capsule contains 500 mg and contains seven beneficial bacterial strains.The probiotic supplement is manufactured by “Zist Takhmir pharmaceutical company” in Tehran, Iran. Intervention 2: Intervention group: 68 patients receive 60 placebo capsules (2 capsules daily for one month) and this continues for three months. Each placebo capsule is similar to the probiotic capsule in Shape, size and color. The placebo is manufactured by “Zist Takhmir pharmaceutical company” in Tehran, Iran. 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 No more information
public Shima Raeesi
Ziaeian Hospital, lower than Aboozar Square, Aboozar Street
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6031 shraeesi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Shima Raeesi
Ziaeian Hospital, lower than Aboozar Square, Aboozar Street
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6031 shraeesi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) patients aged 60 and older According to the 2011NIA-AA criteria for dementia in the mild to moderate stage Obtaining informed consent 60 years no limit Both Chronic infections Consumption any products that contain probiotics or prebiotics during the recent 6 months Taking any kind of antibiotics during the month before starting the study History of any severe gastrointestinal diseases including celiac disease, inflammatory bowel diseases and diverticulitis or gastrointestinal surgery Alcohol consumption during 1 month before Suffering from severe heart disease, severe renal or liver impairment Patients with frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), Parkinson’s disease dementia (PDD) and any demented patients in severe stage, are also excluded because of their different nature and progression manner Occurrence of delirium at the beginning of the study F01 G30 Vascular dementia Alzheimer's disease Treatment - Drugs Placebo Intervention group: 68 patients receive 60 probiotic capsules (2 capsules daily for one month) and this continues for three months. Each probiotic capsule contains 500 mg and contains seven beneficial bacterial strains.The probiotic supplement is manufactured by “Zist Takhmir pharmaceutical company” in Tehran, Iran. Intervention group: 68 patients receive 60 placebo capsules (2 capsules daily for one month) and this continues for three months. Each placebo capsule is similar to the probiotic capsule in Shape, size and color. The placebo is manufactured by “Zist Takhmir pharmaceutical company” in Tehran, Iran. Mini Mental State Examination. Timepoint: The beginning of the study - 3 months later. Method of measurement: Mini Mental State Examination (MMSE) test. Functional assessment staging. Timepoint: The beginning of the study - 3 months later. Method of measurement: Functional assessment staging test (FAST)؛ Barthel Index. Metabolic status. Timepoint: The beginning of the study - 3 months later. Method of measurement: Chek Serum TG، Total Chol، HDL،LDL، FBS، Alb، Vit D. Tehran University of Medical Sciences Approved 2019-05-25 Ethics Committee on Biomedical Research of Tehran University of Medical Sciences Tehran University of Medical Sciences, Qods Corner, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)