The Gut - PRO Study (NCT07413744) | Clinical Trial Compass
Not Yet RecruitingPhase 2
The Gut - PRO Study
United States40 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* MCI/AD or cognitively unimpaired, referred from a Wisconsin clinic that is part of the Wisconsin Alzheimer's Institute's (WAI) network, or recruited from the community. May have participated in:
* Alzheimer's Disease Research Center (ADRC) clinical core study (2011-0030)
* ADCP (26695, MCW IRB)
* Synapse study (2018-1283)
* ADRC Recruitment Registry (2016-0735)
* At least 60 years of age or older
* Good general health (other than cognitive impairment/dementia) with no conditions/medications affecting the gut microbiome (see exclusion criteria below)
* 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
* An informant to answer questionnaires about the participant
Additional inclusion criteria for unimpaired participants:
* Has MOCA score that falls within the range defined for cognitively healthy individuals
Additional inclusion criteria for participants with MCI/AD
* Abnormal cognitive function documented by neuropsychological testing
* ADRC (2015-0030) Consensus Diagnosis Conference indicates dementia or MCI due to AD (for ADRC, ADCP, and Synapse participants only)
* Meets NIA-AA criteria for MCI or AD.
Exclusion Criteria:
* Active or previous (within 6 months) participation in an …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety: Proportion of participants with an adverse event (AE) occurring during any point of the study
Timeframe: up to 36 weeks
2
Safety: Proportion of participants with a severe adverse event (SAE) occurring during any point of the study
Timeframe: up to 36 weeks
3
Feasibility: Number of weeks or months needed to meet study group numbers
Timeframe: up to 36 weeks
4
Feasibility: Proportion of individuals expressing interest in study who are Eligible
Timeframe: baseline
5
Feasibility: Proportion of Participants Who Complete 80 percent of Oral PS
Timeframe: week 24
6
Feasibility: Proportion of Participants Who Complete Intervention