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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191008045024N1
Enrollment
68
Registered
2019-12-28
Start date
2019-10-23
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShima Raeesi

Tehran University of Medical Sciences

shraeesi@sina.tums.ac.ir+98 21 5517 6031

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026