Investigation of the probiotic effects of local strains on cognitive function and quality of life in people with Alzheimer's disease will be done.
Design
The study will be a randomized, placebo-controlled trial studying people with mild to moderate AD. Participants will be randomly assigned to receive a probiotic supplement or a placebo for 12 weeks
Settings and conduct
People with mild to moderate AD disease in Imam Khomeini Hospital of Urmia
Participants/Inclusion and exclusion criteria
Inclusion criteria included subjects with mild to moderate AD, diagnosed by a neurologist or psychiatrist, with a Mini-Mental State Examination (MMSE) score between 10 and 24. Exclusion criteria included subjects with significant hearing or vision impairments, unstable medical conditions, recent hospitalization, recent changes in medication regimen, and recent use of antibiotics or probiotics.
Intervention groups
The study will be a randomized, placebo-controlled trial studying people with mild to moderate AD.
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
LAB
IRCT registration information
IRCT registration number:IRCT20240410061465N2
Registration date:2024-04-26, 1403/02/07
Registration timing:prospective
Last update:2024-04-26, 1403/02/07
Update count:0
Registration date
2024-04-26, 1403/02/07
Registrant information
Name
Hadi Maleki-Kakelar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3348 6165
Email address
maleki.hadi@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of native engineered probiotic supplement on cognitive function and quality of life of Alzheimer's patients
Public title
Probiotic supplement for Alzheimer's patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with mild to moderate Alzheimer's
Exclusion criteria:
Patient non-cooperation during treatment
Possible death of the patient during the study according to the nature of the disease
Age
From 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Urmia University of Medical Sciences
Street address
No 1, Secend alley, Rodaki Avenue, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5719161583
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.UMSU.REC.1402.384
Health conditions studied
1
Description of health condition studied
Alzheimer's disease
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease
Primary outcomes
1
Description
Quality of Life
Timepoint
before the start of the study and after 6 weeks and the end of the study
Method of measurement
questionnaire
2
Description
Cognitive performance of people
Timepoint
Start and end of study
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with mild to moderate Alzheimer's are over 60 years old, diagnosed by a neurologist, with a small mental state examination score between 10 and 24, the dosage is one pill a day, the duration of use is 12 weeks, the pill is in collaboration with zist Company Fermentation is provided.
Category
Treatment - Drugs
2
Description
Control group: Patients with mild to moderate Alzheimer's are over 60 years old and are diagnosed by a neurologist with a score of the Small Mental Status Examination between 10 and 24. The dosage is one placebo per day, the duration of use is 12 weeks, and the pills are in cooperation with Zist Company fermentation is provided.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hadi Maleki-Kakelar
Street address
No 1, Secend alley, Rodaki Avenue, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5719161583
Phone
+98 44 3348 6165
Email
Maleki.hadi@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hadi Maleki-Kakelar
Street address
No 1, Secend alley, Rodaki Avenue, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5719161583
Phone
+98 44 3348 6165
Email
maleki.hadi@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hadi Maleki-Kakelar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
3rd Floor, Hakim Jarjani Building, Shafa Street, Ershad Blvd, Cellular and Molecular Research Institute
City
Urmia
Province
West Azarbaijan
Postal code
5719161583
Phone
+98 44 3348 6165
Fax
Email
Maleki.hadi@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hadi Maleki-Kakelar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
3rd Floor, Hakim Jarjani Building, Shafa Street, Ershad Blvd, Cellular and Molecular Research Institute
City
Urmia
Province
West Azarbaijan
Postal code
5719161583
Phone
+98 44 3348 6165
Fax
Email
Maleki.hadi@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hadi Maleki-Kakelar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
3rd Floor, Hakim Jarjani Building, Shafa Street, Ershad Blvd, Cellular and Molecular Research Institute
City
Urmia
Province
West Azarbaijan
Postal code
5719161583
Phone
+98 44 3348 6165
Fax
Email
Maleki.hadi@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
A part of the results related to the main result can be shared.
When the data will become available and for how long
6 months after publishing and printing the results
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
It can be used if permission is obtained from the person in charge of the design and giving a reference
From where data/document is obtainable
Project manager at Urmia University of Medical Sciences
What processes are involved for a request to access data/document
The application to the research and technology vice-chancellor of the university and after review and approval to the project manager requires 2 working weeks.