An Early Phase 1 interventional study of Probiotic Blend Capsule in Neurodegenerative Diseases and Cognition Disorders in Old Age, sponsored by University of Nicosia. Recruiting at 1 site in Cyprus. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of Nicosia · Early Phase 1, Interventional, and Treatment
The main objective is to investigate whether administration of probiotics to patients with mild Alzheimer's Disease (AD) reduces neuroinflammation, improves cognitive function and modifies neurophysiological measures, compared to a patient group that receives placebo (no active probiotics).
We will measure specific blood inflammatory markers (primary outcome), neurophysiological activity, cognitive test scores, microbiome composition and dietary habits of participants in the probiotics and placebo group.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Nicosia is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Compared within Alzheimer Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neurodegenerative Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received 1 capsule daily of probiotics, administered orally for 16 weeks.
Drug: Probiotic Blend Capsule
Participants received 1 capsule daily of placebo, administered orally for 16 weeks.
Drug: Probiotic Blend Capsule
20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)
Also known as: Ultrabiotique Equilibre 30 Vitavea
Level of inflammatory markers
Peripheral inflammation markers implicated in the pathogenesis of mild-AD (pro-inflammatory cytokines: IL-6, IL-1β, CXCL2, NLRP3; anti-inflammatory cytokines: IL-10. Isolated from blood plasma.
Time frame: Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Mini-Mental State Examination (MMSE)
Time frame: Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Rey-Osterrieth complex figure test
Time frame: Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Wechsler Abbreviated Scale of Intelligence (WASI)
Time frame: Baseline (week 0), end of study (week 16)
Neurophysiological activity changes
Electroencephalogram (EEG) and electrocardiogram (EKG) measured at rest (eyes open, eyes closed).
Time frame: Baseline (week 0), end of study (week 16)
Microbiome profile
16S rDNA gene sequencing for bacterial identification, taxonomic profiling.
Time frame: Baseline (week 0)
Dietary habits
Food Frequency Questionnaire (confounding)
Time frame: Baseline (week 0)
Plan to share: Undecided
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