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The Gut - PRO Study

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Mar 2029 → Sep 2029
See other at-risk trials from University of Wisconsin, Madison

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date pushed from Sep 2026 to Oct 2026
  2. Recruitment opened Show 4 more changesShow less
    • Eligibility criteria expanded, about 44 words
    • Site details revised
    • Collaborators: details revised at 1 of 2 entries
    • Study description expanded, about 4 words
  3. Re-verified, no change to tracked fieldsv9
  4. Phase changed: Phase 2 → Phase 1
    • Primary and study completion pushed from Mar 2029 to Sep 2029
    v8
  5. Primary and study completion dates: Mar 2029 to Sep 2029
    • Start date: Aug 2026 to Sep 2026
    v7
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jun 2026 to Aug 2026v6
  2. Start date: May 2026 to Jun 2026v5
  1. Primary endpoint(s) modified
    • Start date: Apr 2026 to May 2026
    v4
  2. Primary endpoints revised (6)
    • Eligibility criteria expanded, about 9 words
    v3
  3. Start date: Mar 2026 to Apr 2026v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07413744
Lead Sponsor University of Wisconsin, Madison
Collaborators: International Flavors & Fragrances Inc., National Institute on Aging (NIA)
Conditions
(from sponsor)		 Alzheimer Disease
Related terms Alzheimer Disease
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov