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AzTrials

Alzheimer DiseasePhase 1NCT07413744

The Gut - PRO Study

A Phase 1 study testing Probiotic in people with Alzheimer Disease, run by University of Wisconsin, Madison at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
Probiotic
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Oct 2026to Sep 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • Illiterate, blind, or non-English speaking
  • Known periodic antibiotic use (i.e., prior to dental appointments)
  • Oral PS-specific exclusion criteria:
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alfred Braceros, BA contact

608-263-9485

braceros@medicine.wisc.edu

United States1 site, 1 recruiting

  • University of Wisconsin Hospitals and Clinics

    Madison, Wisconsin, 53792

    Barbara Bendlin, PhD

    Federico Rey, PhD

    Recruiting

Other trials in United States

About this study

Official title: Probiotic Supplementation Safety and Feasibility Study in Preclinical Alzheimer's Disease

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.

Read the detailed description

40 participants will be enrolled. 20 with dementia or mild cognitive impairment (MCI) due to Alzheimer's disease (biomarker confirmed amyloid positivity), and 20 unimpaired cognition, enriched for elevated amyloid (approximately 75-80% amyloid positive). Dementia/mild cognitive impairment will be determined according to 2024 NIA-AA criteria.

Primary Objective

  • To assess the safety and feasibility (recruitment, eligibility, enrollment, completion, and follow-up) of an oral probiotic supplementation (PS) intervention in humans with or at risk for dementia due to AD.

Exploratory Objectives

  • To demonstrate the effects of PS on the composition and function of the gut microbiota in humans with or at risk for dementia due to AD.
  • To collect preliminary data in order to estimate sample size and other critical parameters for a larger study.
  • To examine potential mechanisms by which the gut impacts brain, including leading candidate mechanisms such as intestinal permeability and change to bile acid milieu.
Being tested
Probiotic, Placebo
Keywords
probiotics
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProbioticDrug

    Also called Encapsulated probiotic preparation

    A single dose of oral PS will be administered once daily for 6 months

  • PlaceboOther

    A placebo will be given once daily for 6 months.

Study groups in NCT07413744
Study groupRoleWhat they receive
Cognitively Impaired due to AD: ProbioticExperimentalDiagnosis of mild cognitive impairment (MCI) or dementia
Receives: Drug: Probiotic
Cognitively Impaired due to AD: PlaceboPlacebo comparatorDiagnosis of mild cognitive impairment (MCI) or dementia
Receives: Other: Placebo
Cognitively Unimpaired Amyloid Positive: ProbioticExperimentalNot described
Receives: Drug: Probiotic
Cognitively Unimpaired Amyloid Positive: PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Proportion of participants with an adverse event (AE) occurring during any point of the study

    Measured: up to 36 weeks

  2. Safety: Proportion of participants with a severe adverse event (SAE) occurring during any point of the study

    Measured: up to 36 weeks

  3. Feasibility: Number of weeks or months needed to meet study group numbers

    Measured: up to 36 weeks

  4. Feasibility: Proportion of individuals expressing interest in study who are Eligible

    Measured: baseline

  5. Feasibility: Proportion of Participants Who Complete 80 percent of Oral PS

    Measured: week 24

  6. Feasibility: Proportion of Participants Who Complete Intervention

    Measured: up to 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionSep 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Safety and feasibility study, randomized, double blinded, placebo-controlled
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07413744
Sponsor's protocol ID
2024-0622
Other IDs
1R61AG088913-01A1, A534255, Protocol Version 8/7/26
Status last verified
Sep 2026
First submitted
7 Jan 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Collected specimens (including stool, blood, and CSF) will be stored and may be used for future research. Participants will be asked to consent to the use of the samples for future research.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Probiotic in people with Alzheimer Disease, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alfred Braceros, BA (608-263-9485, braceros@medicine.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07413744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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