The Gut - PRO Study
ConditionAlzheimer Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
Qualifiers
Alzheimer's Disease Research Center (ADRC) clinical core study (2011-0030)
ADCP (26695, MCW IRB)
Synapse study (2018-1283)
ADRC Recruitment Registry (2016-0735)
Disqualifiers
Willing and able to comply with all study procedures for the duration of the study
Able to provide signed and dated informed consent form
Participant is not pregnant, lactating or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)
Able to take oral medications
Trial design
Treatments tested in this trial
- Probiotic
- Placebo
Treatment groups
40 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
International Flavors & Fragrances Inc.
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov