Effect of Probiotics Supplementation on Cognitive Status, Daily Life Function and Metabolic Indexes

Phase 3

Recruiting

Conditions: Condition 1: Dementia. Condition 2: Alzheimer's disease.
Vascular dementia
Alzheimer's disease

Registration Number: IRCT20191008045024N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 68

Inclusion Criteria

patients aged 60 and older
According to the 2011NIA-AA criteria for dementia in the mild to moderate stage
Obtaining informed consent

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures