NCT07413744

The Gut - PRO Study

Probiotic Supplementation Safety and Feasibility Study in Preclinical Alzheimer's Disease

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and feasibility of an oral probiotic supplement (PS) intervention in individuals with dementia or mild-cognitive impairment (MCI) due to Alzheimer's disease or at risk of dementia due to Alzheimer's disease (AD). 40 participants will be enrolled and can expect to be on study for up to 1 year.

Detailed description

40 participants will be enrolled. 20 with dementia or mild cognitive impairment (MCI) due to Alzheimer's disease (biomarker confirmed amyloid positivity), and 20 unimpaired cognition, enriched for elevated amyloid (approximately 75-80% amyloid positive). Dementia/mild cognitive impairment will be determined according to 2024 NIA-AA criteria. Primary Objective * To assess the safety and feasibility (recruitment, eligibility, enrollment, completion, and follow-up) of an oral probiotic supplementation (PS) intervention in humans with or at risk for dementia due to AD. Exploratory Objectives * To demonstrate the effects of PS on the composition and function of the gut microbiota in humans with or at risk for dementia due to AD. * To collect preliminary data in order to estimate sample size and other critical parameters for a larger study. * To examine potential mechanisms by which the gut impacts brain, including leading candidate mechanisms such as intestinal permeability and change to bile acid milieu.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Probiotic	A single dose of oral PS will be administered once daily for 6 months
OTHER	Placebo	A placebo will be given once daily for 6 months.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2026-02-17
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study