Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202305650866475 Date of Approval: 16/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessing the therapeutic effect of probiotics on individuals in mild cognitive impairment.
Official scientific title Assessing the therapeutic effect of probiotics on individuals with mild cognitive impairment at Korle - Bu Teaching Hospital.
Brief summary describing the background and objectives of the trial Background Dysbiosis of the intestinal microbiota has been linked to cognitive function and appears to worsen with ageing. Ageing is a process that includes changes in cognitive functioning, and changes in the diversity and integrity of the gut microbiota. Probiotic treatments have recently been explored as a potential new therapeutic approach to alleviate a variety of disorders; However, clinical trials in older adults remain insufficient and limited. Therefore, this project aims to evaluate the efficacy of a multispecies probiotic formulation as a therapeutic strategy to mitigate age-related cognitive decline in adults with mild cognitive impairment. Aim The project's major goal is to assess probiotics' therapeutic effect in mild cognitively impaired individuals. Methodology The study will be a double-blind, placebo-controlled, randomized clinical trial. One hundred participants’ adults aged 50–75 will be enrolled (50 mild cognitive impaired individuals and 50 control groups with an equal ratio of female versus male and age bracket). Before and after the six-month intervention involving daily consumption of Lactobacillus reuteri (5 billion CFU/day) and placebo, stool and blood samples will be collected to determine the diversity of the gut microbiome and measure Amyloid-beta 40-42 levels, lipid profile, vitamin B12, folic acid and blood glucose. Magnetic resonance imaging will be used for brain volume analysis. Montreal cognitive assessment tool (MoCA) will be used for the diagnosis of cognitively impaired individuals. Independent sample t-tests, chi-squared tests, and repeated measure ANOVAs compared groups and examined changes over time. Expected outcome The probiotic supplementation for six months will lead to a rebalancing of the gut microbiome, which will improve cognitive function.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ATPMCI
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 22/05/2023
Actual trial start date 05/06/2023
Anticipated date of last follow up 11/12/2023
Actual Last follow-up date 18/12/2023
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 100
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mild cognitive impairment group 4 billion CFU Lactobacillus reuteri. 6 months In the intervention group (n = 50), patients will receive 5 billion CFU/day powder probiotics containing Lactobacillus reuteri will be dissolved in 200ml of water for six months. It is generally agreed that probiotic strains should be of host origin with a beneficial effect on the host, withstand foodstuff with a high count, withstand transits through the intestine and colonize the lumen of the tract, produce antimicrobial agents, and be technologically appropriate for industrial production ( (Shewale et al., 2014). Due to the lack of evidence about the appropriate dosage of probiotics for AD, we used the above-mentioned doses based on a few previous studies in healthy subjects (Benton et al., 2007; Mohammadi et al., 2015). Probiotic supplements will be produced by Probiotic Australia(Queensland, Australia) which will be approved by the Food and Drug Organization of the Ministry of Health and Medical Education. 50
Control Group Placebo 4 billion CFU 6 months In the control group (n = 50), patients will receive 4 billion CFU/day placebo which will be dissolve in water for six months. 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• The subject is between 50-75 years old. • The subject is clinically diagnosed with Mild cognitive impairment by the Neurologist. • The subject's MoCA score is between 10-26. • The subject can cooperate to perform cognitive function tests. • The subject has dependable caregivers who can record the compliance of taking probiotics and any physical conditions. • The subject or family members signed the informed consent form and answered the questionnaire. • The subject has dementia caused by other reasons, such as brain trauma, tumour, infection, epilepsy, etc. • The subject has consumed probiotic-related products (probiotic powder, yoghurt or other fermented foods) within the past 1 month. • The subject has participated in clinical trials of other dementia medications in the past 1 month. • The subject is assessed for dementia caused by vitamin B12 deficiency or thyroid abnormalities. • The subject suffers from mental illness, severe depression, schizophrenia, drug addiction, and alcohol addiction. • The subject has Parkinson's disease. • The subject is assessed to have severe metabolic and liver and kidney dysfunction. Aged: 65+ Year(s) 50 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/06/2023 Korle bu Teachinh Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2nd Guggisberg Avenue -Korle Bu Accra 00233 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/10/2023 Western Sydney University Human Research ethics committe
Ethics Committee Address
Street address City Postal code Country
Penrith NSW 2751 Sydney 2751 Australia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/06/2023 Korle Bu Teaching Hopsital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2nd Guggisberg Avenue - Korle Bu Accra Accra 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome  cognitive function measured using an appropriate, validated cognitive test, gut microbiota diversity and composition 80
Secondary Outcome  changes in metabolic variables, Biomarkers and cognitive function  Randomized controlled trials (RCTs) and clinical controlled trials (CCTs) 80
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Korle Bu Teaching Hospital 22nd Guggisberg Avenue, Accra, Ghana. Accra 00233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
WESTERN SYDNEY UNIVERSITY Penrith NSW 2751 NEW SOUTH WALES 2751 Australia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor WESTERN SYDNEY UNIVERSITY Penrith NSW 2751 NEW SOUTH WALES 2751 Australia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MICHAEL QUANSAH M.Quansah@westernsydney.edu.au +233243944269 DANSOMAN HIGH STREET
City Postal code Country Position/Affiliation
ACCRA 00233 Ghana PhD student
Role Name Email Phone Street address
Public Enquiries Patrick Adjei PAdjei@ug.edu.gh +233549581079 22ND Guggisbberg avenue
City Postal code Country Position/Affiliation
Accra 00233 Ghana Head of Medicine department of Korle Bu Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Mourad Tayebi M.Tayebi@westernsydney.edu.au +61478921309 Campbell town street
City Postal code Country Position/Affiliation
New South Wales 5074 Australia Head of Neuroimmunology lab School of Medicine Western Sydney University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Study Protocol one year The data analysis and result will be permitted for participant
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information