Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyrate Effects Via the Gut-Brain

The goal of this clinical trial is to learn if tributyrin can help prevent or mitigate cognitive decline in individuals with mild Alzheimer's disease (AD). The trial will also examine the safety and effects of tributyrin on inflammation and gut microbiota. The main questions it aims to answer are: Does tributyrin reduce inflammation and neurodegeneration markers? How does tributyrin affect gut microbiota and intestinal permeability? Researchers will compare tributyrin to a placebo (a look-alike substance that contains no active ingredient) to evaluate its effectiveness. Participants will: Take tributyrin or a placebo every day for 12 weeks. Undergo assessments of cognitive function, blood markers (such as NfL and pTau217), and gut health. The findings are expected to provide insight into the potential of tributyrin as a preventive intervention for Alzheimer's disease.

NCT Number	NCT06797817
Lead Sponsor	Universidad de Almeria
Conditions	Alzheimer Disease (AD)
Enrollment	156 participants
Start Date	2026-06-01
Primary Completion	2026-09-01 (estimated)
Study Completion	2029-09-02 (estimated)
Updated on ClinicalTrials.gov	2025-12-18