The Gut - PRO Study for Alzheimer's Disease
This study, called The Gut - PRO Study, is looking at a probiotic supplement (PS) to see if it is safe and practical for people with Alzheimer's disease (AD) or mild cognitive impairment (MCI), or those at risk for AD. You would take a single dose of oral PS or a placebo (an inactive substance) once daily for 6 months. The study aims to enroll 40 participants, including those with MCI/AD and those with normal cognition but elevated amyloid levels (a marker for AD). Researchers will track any side effects and how easy it is to recruit and keep participants in the study. The study is also exploring how the probiotic might affect gut health and its connection to the brain. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 40 participants. It compares a probiotic (PS) to a placebo.
- What's involved
- You would take a daily oral dose for 6 months and be on study for up to 1 year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be measured for up to 36 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07413744
The Gut - PRO Study
Not Yet Recruiting
PHASE2Ages 60+InterventionalTreatmentUniversity of Wisconsin, MadisonInvestigator-initiated
~40 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:ProbioticPlacebo
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety: Proportion of participants with an adverse event (AE) occurring during any point of the study
Measured over up to 36 weeks
+5 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesWisconsin1
Study leadership
- Barbara Bendlin, PhD · PRINCIPAL_INVESTIGATOR · UW School of Medicine and Public Health
- Federico Rey, PhD · PRINCIPAL_INVESTIGATOR · Department of Bacteriology
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Has MOCA score that falls within the range defined for cognitively healthy individuals
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
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
Active or previous (within 6 months) participation in an Alzheimer's clinical intervention/trial (can be included if previously enrolled in placebo or control group)
Standard clinical care for dementia and medications used to treat MCI and Alzheimer's disease are acceptable, including monoclonal antibody therapy
Significant neurologic disease: Any significant neurologic disease, such as Parkinson's disease, stroke, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, subdural hematoma, multiple sclerosis, seizure disorder, or other significant deficits other than Alzheimer's or Mild Cognitive Impairment
Alcohol/substance: history of alcohol/substance dependence in the past year.
Significant medical illness: any significant systemic illness or unstable medical condition occurring during ADRC participation that could affect cognition (other than MCI/AD). Examples include malignant cancer, chemotherapy, HIV, untreated thyroid disease, heart failure, or renal insufficiency
Current diagnosis with diabetes
Illiterate, blind, or non-English speaking
Known periodic antibiotic use (i.e., prior to dental appointments)
Inability (e.g., dysphagia) or unwilling to swallow capsules
Active gastrointestinal infection at time of enrollment
Known or suspected toxic megacolon and/or known small bowel ileus
History of total colectomy or bariatric surgery
Concurrent intensive induction chemotherapy, radiation therapy, or biological treatment for active malignancy
Unable or unwilling to comply with protocol requirements
Expected life expectancy less than 6 months
Previous use of probiotic supplementation (PS) or microbiome-based products within 2 months, large doses of commercial probiotics consumed (greater than or equal to 10\^8 cfu or organisms per day). Includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component (ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply). Enrollment after 2 months without probiotic use can be considered for eligibility
Patients with severe anaphylactic or anaphylactoid food allergy
Solid organ transplant recipients less than or equal to 90 days post-transplant or on active treatment for rejection
A condition that would jeopardize the safety or rights of the participant, would make it unlikely for the participant to complete the study, or would confound the results of the study
Exclusionary factors affecting the microbiome:
Previous use of systemic antibiotics (intravenous, intramuscular, or oral) within 3 months (depends on the duration of antibiotic use, i.e., less than 3 months is considered exclusion, however, enrollment after 3 months without antibiotic use can be considered for eligibility)
Immune stimulating and/or suppressing medications
Immunosuppressed as evaluated by complete blood count (CBC) with differential, which includes white blood cell count, total neutrophil count, and total lymphocyte count
Unstable dietary history during the previous month, which is defined as major changes in diet by eliminating or significantly increasing a major food group
Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years
Major bowel resection at any time
Active uncontrolled gastrointestinal disorders or disease including inflammatory bowel disease, ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis; irritable bowel syndrome (moderate-severe); persistent, infectious gastroenteritis, colitis, or gastritis; persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated), or chronic constipation
What this trial measures
- Safety: Proportion of participants with an adverse event (AE) occurring during any point of the studyup to 36 weeks
- Safety: Proportion of participants with a severe adverse event (SAE) occurring during any point of the studyup to 36 weeks
- Feasibility: Number of weeks or months needed to meet study group numbersup to 36 weeks
- Feasibility: Proportion of individuals expressing interest in study who are Eligiblebaseline
- Feasibility: Proportion of Participants Who Complete 80 percent of Oral PSweek 24
- Feasibility: Proportion of Participants Who Complete Interventionup to 36 weeks