NCT05145881

Effect of Probiotics in Alzheimer's Disease

Completed NA Last updated 18 March 2025

What this trial tests

NA trial testing Low dose probiotics in Alzheimer Disease in 40 participants. Completed in 20 June 2023.

Timeline

2 April 2020

Primary endpoint
20 June 2023

20 June 2023

Quick facts

Lead sponsor	Hsieh-Hsun Ho
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	2 April 2020
Primary completion	20 June 2023
Estimated completion	20 June 2023
Sites	1 location across Taiwan

Drugs / interventions tested

• Low dose probiotics
• Normal dose probiotics

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Hsieh-Hsun Ho

Who can join

Adults 50 to 95, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this clinical trial, five strains of probiotics (Bifidobacterium breve Bv-889, B. longum subspecies infantis BLI-02, B. bifidum VDD088, B. animalis subsp. lactis CP-9, Lactobacillus plantarum PL-02) with anti-oxidant and anti-inflammatory functions will been applied to slow down the development of the Alzheimer's disease through regulating the intestinal flora and immune system of patients with mild to moderate Alzheimer's disease symptoms. The efficacy of probiotic treatment against Alzheimer's disease will be evaluated.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. An Overview of Oxidative Stress, Neuroinflammation, and Neurodegenerative Diseases.
   Teleanu DM, Niculescu AG, Lungu II, Radu CI, et al · · 2022 · cited 672× · PMID 35682615 · DOI 10.3390/ijms23115938
2. Microbiota-gut-brain axis and its therapeutic applications in neurodegenerative diseases.
   Loh JS, Mak WQ, Tan LKS, Ng CX, et al · · 2024 · cited 631× · PMID 38360862 · DOI 10.1038/s41392-024-01743-1
3. Efficacy of Probiotic Supplements on Brain-Derived Neurotrophic Factor, Inflammatory Biomarkers, Oxidative Stress and Cognitive Function in Patients with Alzheimer's Dementia: A 12-Week Randomized, Double-Blind Active-Controlled Study.
   Hsu YC, Huang YY, Tsai SY, Kuo YW, et al · · 2023 · cited 68× · PMID 38201846 · DOI 10.3390/nu16010016
4. Proteostasis failure exacerbates neuronal circuit dysfunction and sleep impairments in Alzheimer's disease.
   Morrone CD, Raghuraman R, Hussaini SA, Yu WH. · · 2023 · cited 40× · PMID 37085942 · DOI 10.1186/s13024-023-00617-4
5. Gut-brain axis: gut dysbiosis and psychiatric disorders in Alzheimer's and Parkinson's disease.
   Denman CR, Park SM, Jo J. · · 2023 · cited 20× · PMID 38075261 · DOI 10.3389/fnins.2023.1268419
6. Recent advances in therapeutic probiotics: insights from human trials.
   Cho M-Y, Eom J-H, Choi E-M, Yang S-J, et al · · 2025 · cited 17× · PMID 40261032 · DOI 10.1128/cmr.00240-24
7. The Role of Dietary Antioxidants and Their Potential Mechanisms in Alzheimer's Disease Treatment.
   Knight E, Geetha T, Broderick TL, Babu JR. · · 2023 · cited 9× · PMID 36984879 · DOI 10.3390/metabo13030438
8. Biologics as Therapeutical Agents Under Perspective Clinical Studies for Alzheimer's Disease.
   Li H, Shen X, Zhang B, Zhu Z. · · 2025 · cited 7× · PMID 40942007 · DOI 10.3390/molecules30173479