Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
40 participants
INTERVENTIONAL
2022-12-19
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Probiotics
Participants received 1 capsule daily of probiotics, administered orally for 16 weeks.
Probiotic Blend Capsule
20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)
Placebo
Participants received 1 capsule daily of placebo, administered orally for 16 weeks.
Probiotic Blend Capsule
20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)
Interventions
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Probiotic Blend Capsule
20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mini-Mental State Examination (MMSE) scores 19-23 (mild AD)
* approximately equal male:female ratio
Exclusion Criteria
* other neurological disease
* relevant psychiatric disorders (e.g. major depression)
* gastrointestinal/metabolic conditions
* history of alcohol/substance dependence
* use of systemic antibiotics in the previous 6 months
* corticosteroid use
* immune stimulating medications
* immunosuppressive agents
* probiotics consumption in the previous 6 months.
* immunosuppression
* structural heart disease
* neutropenia
* radiation
* active intestinal disease
65 Years
85 Years
ALL
No
Sponsors
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Cyprus Institute of Neurology and Genetics
OTHER
University of Nicosia
OTHER
Responsible Party
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Nicoletta Nicolaou
Associate Professor
Locations
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The Cyprus Institute of Neurology and Genetics
Nicosia, , Cyprus
Countries
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Central Contacts
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Facility Contacts
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Ioanna Kousiappa
Role: primary
Other Identifiers
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AARG-NTF-22-928616
Identifier Type: -
Identifier Source: org_study_id