NCT06797817Not yet recruitingPhase 3
Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyrate Effects Via the Gut-Brain
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 21 Jan 2025
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Universidad de Almeria
- Diseases
- Alzheimer disease
- NCT number
- NCT06797817
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 156
- From 1 Jun 2026 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- individuals involved in an intervention that interferes with the trial (immunosuppressive drugs, steroids, antibiotics, or received chemotherapy in the month prior to the start of the intervention).
Other illness
- individuals with other potential causes of dementia, such as a history of severe traumatic brain injury, brain tumours, epilepsy, or central nervous system infections.
- individuals with gastrointestinal disorders.
Who the study is looking for
- individuals diagnosed with mild AD within the past year (ICD-10: F00.1).
- voluntary consent to participate in the study in accordance with the Declaration of Helsinki.
- not currently enrolled in any other clinical trial that could confound the results.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidad de Almería Coordinator of this site? Confirm its status | Almería | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.