Health TrialsbyHealthPanel

The Gut - PRO Study

ConditionAlzheimer Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Alzheimer's Disease Research Center (ADRC) clinical core study (2011-0030)

ADCP (26695, MCW IRB)

Synapse study (2018-1283)

ADRC Recruitment Registry (2016-0735)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Probiotic

    Drug

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

  • Placebo

    Other intervention

    A placebo will be given once daily for 6 months.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Cognitively Impaired due to AD: ProbioticExperimental treatment 1 intervention
Group B: Cognitively Impaired due to AD: PlaceboPlacebo comparator 1 intervention
Group C: Cognitively Unimpaired Amyloid Positive: ProbioticExperimental treatment 1 intervention
Group D: Cognitively Unimpaired Amyloid Positive: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
up to 36 weeks
2

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

Time frame
up to 36 weeks
3

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

Time frame
up to 36 weeks
4

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

Time frame
baseline

Secondary outcomes

Other outcomes

1

Hemoglobin A1C

Time frame
baseline, week 12, week 24, and week 36
2

Fasting Glucose

Time frame
baseline, week 12, week 24, week 36
3

Fasting Insulin

Time frame
baseline, week 12, week 24, week 36
4

C-reactive protein

Time frame
baseline, week 12, week 24, week 36

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

International Flavors & Fragrances Inc.

Collaborator

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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