Skip to content

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210513051277N1
Enrollment
30
Registered
2021-05-27
Start date
2021-06-22
Completion date
Unknown
Last updated
2021-06-21

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

Conditions

Alzheimer disease. Alzheimer's disease

Interventions

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 s

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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-a. 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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactCamellia Akhgarjand

Tehran University of Medical Sciences

kameliaakhgarjand@yahoo.com+98 21 8895 5975

Outcome results

None listed

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