Probiotics in Mild Alzheimer's Disease

December 19, 2023 updated by: Nicoletta Nicolaou, University of Nicosia

Effect of Probiotics on Cognitive Functioning of Patients With Mild Alzheimer's Disease

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Cyprus
      • Nicosia, Cyprus
        • Recruiting
        • The Cyprus Institute of Neurology and Genetics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults ≥65 years, able to give consent
  • Mini-Mental State Examination (MMSE) scores 19-23 (mild AD)
  • approximately equal male:female ratio

Exclusion Criteria:

  • Inability to give consent
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics
Participants received 1 capsule daily of probiotics, administered orally for 16 weeks.
Drug: Probiotic Blend Capsule
20 million CFU (Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Bifidobacterium breve)
Other Names:
  • Ultrabiotique Equilibre 30 Vitavea
Placebo Comparator: Placebo
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)
Other Names:
  • Ultrabiotique Equilibre 30 Vitavea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of inflammatory markers
Time Frame: Baseline (week 0), end of study (week 16)
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.
Baseline (week 0), end of study (week 16)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function and neuropsychological scores
Time Frame: Baseline (week 0), end of study (week 16)
Mini-Mental State Examination (MMSE)
Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Time Frame: Baseline (week 0), end of study (week 16)
Montreal Cognitive Assessment (MoCA)
Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Time Frame: Baseline (week 0), end of study (week 16)
Rey-Osterrieth complex figure test
Baseline (week 0), end of study (week 16)
Cognitive function and neuropsychological scores
Time Frame: Baseline (week 0), end of study (week 16)
Wechsler Abbreviated Scale of Intelligence (WASI)
Baseline (week 0), end of study (week 16)
Neurophysiological activity changes
Time Frame: Baseline (week 0), end of study (week 16)
Electroencephalogram (EEG) and electrocardiogram (EKG) measured at rest (eyes open, eyes closed).
Baseline (week 0), end of study (week 16)
Microbiome profile
Time Frame: Baseline (week 0)
16S rDNA gene sequencing for bacterial identification, taxonomic profiling.
Baseline (week 0)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary habits
Time Frame: Baseline (week 0)
Food Frequency Questionnaire (confounding)
Baseline (week 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nicosia

Collaborators

Cyprus Institute of Neurology and Genetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AARG-NTF-22-928616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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