Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's Disease — AMBITION  

Alzheimer Disease Clinical Trial

Official title: Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's Disease

Status Terminated

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Alzheimer Disease

• NCT number: NCT03998423
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Status: Terminated
• Phase: Phase 1
• Start date: November 14, 2019
• Completion date: July 14, 2020