The Gut - PRO Study

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07413744
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitively Impaired due to AD: Probiotic
    Diagnosis of mild cognitive impairment (MCI) or dementia
  • Placebo Comparator: Cognitively Impaired due to AD: Placebo
    Diagnosis of mild cognitive impairment (MCI) or dementia
  • Experimental: Cognitively Unimpaired Amyloid Positive: Probiotic
  • Placebo Comparator: Cognitively Unimpaired Amyloid Positive: Placebo

Primary Outcome Measure

Safety: Proportion of participants with an adverse event (AE) occurring during any point of the study [ Time Frame: up to 36 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Hospitals and ClinicsMadisonWisconsin53792
Barbara Bendlin, PhD (PRINCIPAL_INVESTIGATOR)
Federico Rey, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Madison, WI

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of Wisconsin Hospitals and Clinics· Madison, WI

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