NCT05943925: DEM-BIOTA

Dementias and Microbiota Composition: Is Possible to Revert the Dementia Symptoms Reverting the Microbiota Composition?

Status unknown Last updated 13 July 2023

What this trial tests

trial testing No intervention in Dementia Alzheimers in 240 participants. Status unknown.

Timeline

16 April 2021

Primary endpoint
31 January 2025

1 February 2025

Quick facts

Lead sponsor	University Rovira i Virgili
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	240
Start date	16 April 2021
Primary completion	31 January 2025
Estimated completion	1 February 2025
Sites	1 location across Spain

Drugs / interventions tested

• No intervention
• Probiotic supplement — full drug profile →

Conditions studied

• Dementia Alzheimers — all drugs for Dementia Alzheimers →
• Dementia With Lewy Bodies — all drugs for Dementia With Lewy Bodies →
• Parkinson Disease Dementia — all drugs for Parkinson Disease Dementia →
• Dementia Frontotemporal — all drugs for Dementia Frontotemporal →

Sponsor

University Rovira i Virgili

Who can join

60 and older, any sex, with Dementia Alzheimers or Dementia With Lewy Bodies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Dementia is the major cause of disability and dependency among older adults worldwide affecting memory, cognitive abilities and behavior, interfering with one's ability to perform daily lives activities. Although age is the strongest known risk factor for the onset of dementia, it is not a natural or inevitable consequence of aging. Dementia not only affects older people, since up to 9% of the cases appear before 65 years. The impact of dementia is highly important in financial terms also in human costs to countries, societies and individuals.

Dementia is an umbrella term for several diseases, being Alzheimer's disease (AD) the most common form, contributing to 60-70% of cases. Other major forms include Lewy bodies Dementias (LBDs) and frontotemporal dementia (FTD).

The role of the gastrointestinal microbiota in human brain development and function is an area of increasing interest and research. A large number of studies suggest that the gut microbiota can influence the brain, cognition and behavior of the patients, and also modulate brain plasticity, modifying brain chemistry via various mechanisms like neural, immune and endocrine Within these last two years some studies have showed differences in the microbiota of the AD patients from healthy controls. In this sense, increasing number of studies, most of them in animal models, support the notion that probiotics have significant benefit in maintaining homeostasis of the Central Nervous System. And recent studies try to replicate this finding in AD patients with controversial results.

The main objective of DEM-BIOTA project is to improve the knowledge of the relationship between microbiota and dementia. DEM-BIOTA will explore the microbiota differences between dementias: AD, LBDs, that includes: Parkinson disease dementia (PDD) and Lewy Body Dementia (LBD) and FTD-behavioral variant, also in Mild Cognitive Impairment (MCI) to study the progression; in our context (Mediterranean diet and lifestyle) and characterize them in relation to neurocognitive and neuropsychiatric symptoms as well as patient functionality (dependency level). Moreover, the capacity of a probiotic compound in reverting or improving neurocognitive and neuropsychiatric symptoms and patient functionality in a sample of AD patients will be also studied.

Publications & conference data

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

1. 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
2. Gut microbial metabolism in Alzheimer's disease and related dementias.
   Kang JW, Vemuganti V, Kuehn JF, Ulland TK, et al · · 2024 · cited 22× · PMID 39462700 · DOI 10.1016/j.neurot.2024.e00470
3. Gut Microbiota Alterations in Alzheimer's Disease: Relation with Cognitive Impairment and Mediterranean Lifestyle.
   Mateo D, Carrión N, Cabrera C, Heredia L, et al · · 2024 · cited 5× · PMID 39458354 · DOI 10.3390/microorganisms12102046
4. Unraveling brain aging through the lens of oral microbiota.
   Hu Q, Wang S, Zhang W, Qu J, et al · · 2025 · cited 5× · PMID 38993126 · DOI 10.4103/nrr.nrr-d-23-01761
5. Dataset on neuropsychological profile and microbiota composition in cognitively unimpaired elderly and Alzheimer's patients.
   Heredia L, Mateo D, Carrión N, Torrente M. · · 2025 · cited 1× · PMID 40612463 · DOI 10.1016/j.dib.2025.111778
6. Gut microbiota characterization in ageing, mild cognitive impairment, and Alzheimer's disease in the context of mediterranean lifestyle in a Spanish population.
   Cabrera C, Carrión N, Mateo D, Vicens P, et al · · 2025 · PMID 41029837 · DOI 10.1186/s13195-025-01862-z