Exploring the link between gut microbiota and dementia symptoms

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

This study looks at how the bacteria in our gut might be linked to different types of dementia, like Alzheimer's, to see if changes in gut health could help manage symptoms.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: University Rovira i Virgili (other)
• Locations: 1 site (Tarragona)
• Trial ID: NCT05943925 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between gut microbiota composition and various types of dementia, including Alzheimer's disease, Lewy body dementia, frontotemporal dementia, and mild cognitive impairment. The research aims to characterize the microbiota of individuals diagnosed with these conditions compared to healthy subjects, particularly within a Mediterranean context. By analyzing stool samples and cognitive assessments, the study seeks to understand how microbiota differences may influence dementia symptoms and progression. The findings could provide insights into potential dietary or probiotic interventions for managing dementia symptoms.

Who should consider this trial

Good fit: Ideal candidates include individuals over 60 years old diagnosed with Alzheimer's, Lewy body dementia, frontotemporal dementia, or mild cognitive impairment.

Not a fit: Patients with significant comorbid neurological diseases or recent antibiotic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new dietary or probiotic strategies to help manage or alleviate dementia symptoms.

How similar studies have performed: While some studies have explored the gut-brain axis, this specific approach focusing on Mediterranean populations and diverse dementia types is relatively novel.

Eligibility criteria

Inclusion Criteria:

Study 1, microbiota composition study- AD, PD, LBD, FTD-behavioral variant or MCI-amnesic

* diagnosed by the neurology service (or healthy subjects, without any of these diagnostics).
* more than 60 years

Study 2-probiotic intervention,:

* AD diagnosed by the neurology service;
* more than 65 years.

Exclusion Criteria:

Study 1, microbiota study:

* Comorbidity with other significant neurology disease,
* Infectious treatment with antibiotics in the previous 6 months prior to providing the stool sample,
* corticosteroid use,
* immunosuppressors or immunostimulants treatment,
* illnesses of the Gastro Intestinal tract,
* large doses of commercial probiotics consumed (greater than or equal to 10 elevated to 8 colony forming unit per organisms per day).

Study 2-probiotic intervention:

* Comorbidity with other significant neurology disease,
* Infectious treatment with antibiotics in the previous 6 months prior to providing the stool sample,
* corticosteroid use,
* immunosuppressors or immunostimulants treatment,
* illnesses of the GI tract,
* large doses of commercial probiotics consumed (greater than or equal to 10 elevated to 8 cfu per organisms per day).

Where this trial is running

Tarragona

• Dr. Margarita Torrente — Tarragona, Spain (RECRUITING)

Study contacts

• Principal investigator: Margarita Torrente, Dr — University Rovira i Virgili
• Study coordinator: Margarita Torrente, Dr

Conditions: Dementia Alzheimers, Dementia With Lewy Bodies, Parkinson Disease Dementia, Dementia Frontotemporal, Mild Cognitive Impairment, cognitive status, functional status, neuropsychiatric status