NCT03998423

Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's Disease

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to assess the safety and feasibility of an oral fecal microbiota transplant (FMT) intervention for Alzheimer's disease (AD).

Detailed description

Studies suggests that microbes, including those derived from the gut, may play a role in the development or progression of AD. Gut microbiome composition among individuals with the Alzheimer's clinical syndrome is reduced in microbial diversity and shows compositional differences relative to control groups. Further, genera identified as more abundant in AD are associated with greater AD pathology while genera identified as less abundant in AD are associated with less AD pathology, as shown using CSF biomarkers. The goal of this study is to assess the safety and feasibility of an oral fecal microbiota transplant (FMT) intervention. * Primary Objective: To assess the safety and feasibility (recruitment, eligibility, enrollment, completion, and follow-up) of an oral FMT intervention in people with and without the Alzheimer's clinical syndrome. * Secondary Objective: To demonstrate the effects of FMT on the composition and function of the gut microbiota. To collect preliminary data in order to estimate sample size and other parameters for a larger study.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplant	Double-encapsulated Fecal Microbiota Transplant Capsules

Timeline

• Start date: 2019-11-14
• Primary completion: 2020-07-14
• Completion: 2020-07-14
• First posted: 2019-06-26
• Last updated: 2020-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study