IRCT20191008045024N1
Recruiting
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Condition 1: Dementia. Condition 2: Alzheimer's disease.
- Sponsor
- Tehran University of Medical Sciences
- Enrollment
- 68
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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