The Gut - PRO Study

NCT07413744 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: 2024-06221R61AG088913-01A1A534255Protocol Version 4/13/26
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease

Keywords

probiotics

Outcome Measures

Primary Outcomes (6)

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

  up to 36 weeks

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

  up to 36 weeks

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

  up to 36 weeks

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

  baseline

• Feasibility: Proportion of Participants Who Complete 80 percent of Oral PS

  week 24

• Feasibility: Proportion of Participants Who Complete Intervention

  up to 36 weeks

Other Outcomes (23)

• Hemoglobin A1C

  baseline, week 12, week 24, and week 36

• Fasting Glucose

  baseline, week 12, week 24, week 36

• Fasting Insulin

  baseline, week 12, week 24, week 36

Study Arms (4)

Cognitively Impaired due to AD: Probiotic

EXPERIMENTAL

Diagnosis of mild cognitive impairment (MCI) or dementia

Drug: Probiotic

Cognitively Impaired due to AD: Placebo

PLACEBO COMPARATOR

Diagnosis of mild cognitive impairment (MCI) or dementia

Other: Placebo

Cognitively Unimpaired Amyloid Positive: Probiotic

EXPERIMENTAL

Drug: Probiotic

Cognitively Unimpaired Amyloid Positive: Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Probiotic DRUG

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

Also known as: Encapsulated probiotic preparation

Cognitively Impaired due to AD: Probiotic; Cognitively Unimpaired Amyloid Positive: Probiotic

Placebo OTHER

A placebo will be given once daily for 6 months.

Cognitively Impaired due to AD: Placebo; Cognitively Unimpaired Amyloid Positive: Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• International Flavors & Fragrances Inc.: collaborator
• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Barbara Bendlin, PhD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

• Federico Rey, PhD

  Department of Bacteriology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfred Braceros, BA

CONTACT

608-263-9485; braceros@medicine.wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Safety and feasibility study, randomized, double blinded, placebo-controlled

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: February 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The samples will be kept until all analyses for this project are complete or until the samples are exhausted.
• Access Criteria: Drs. Bendlin and Rey will review all requests to utilize the data, tissue, and results of specimen analysis.

Locations

US (1)