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A daily probiotic drink may soothe the gut and brain in dementia

NCT ID NCT07800195

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Researchers at the University of South Florida are testing whether a daily probiotic fermented milk drink can improve gut health and reduce inflammation in people with Alzheimer's disease and related dementias, as well as their caregivers. The study will give 40 participants either the probiotic drink or a placebo for 30 days. The team will measure changes in gut bacteria, nutrient absorption, and markers of inflammation. This pilot study aims to gather early data on whether probiotic nutrition could support both gut and brain health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A probiotic fermented milk drink containing four human-derived probiotic strains
What this could lead to
If it works, this could point toward a simple daily drink that supports gut and brain health in people with dementia and their caregivers.
What could go wrong
This is a small pilot study with only 40 participants, so results may not apply broadly. The drink may not change gut bacteria or inflammation as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria:• Diagnosed with ADRD and accompanied with their caregiver * Age ≥ 18 years old * Willing to consume PFM and/or willing to consume placebo drink, follow instructions of study team and sign consent form Exclusion Criteria: * Lactose intolerance or another intolerance that prevents the safe consumption of dairy products * Allergy to any ingredients in the PFM formulations, including almonds/nuts, lactose/dairy, dextrose, artificial sweeteners, or dyes used in flavoring * Known allergy or hypersensitivity to peanuts or soy, as indicated on the pectin product label. * Known allergy, intolerance, or hypersensitivity to Ensure® or any of its components. * Cancer patients receiving chemotherapy, due to potential increased risk of infection from GI tract damage * Participants who require systemic antibiotics after randomization will have the antibiotic use documented and will be withdrawn due to potential effects on the gut microbiome. Data collected prior to antibiotic use may be retained, and withdrawn participants will be replaced to maintain the target sample size. * Major surgery(ies) of the gut or brain within the past five years * Diagnosis of inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, acid reflux, gastroesophageal reflux disease (GERD), Clostridium difficile infection (CDI), or any other gastrointestinal disease that could significantly change the microbiome History of fecal microbiota transplantation * Small intestinal bacterial overgrowth * History of anticipatory nausea, vomiting, constipation, or diarrhea * Antibiotic or probiotic or heavy yogurt (3 servings per day) use within the past 30 days o Probiotic use is defined as consumption of ≥108 CFU/day, in the form of tablets, capsules, lozenges, powders, or dairy products in which probiotics are a major ingredient * Critical or terminal illnesses including diabetes * Pregnant women will be excluded from the study based on self-report during the screening process. No pregnancy testing kits will be provided, and pregnancy testing will not be performed as part of this study. Therefore, individuals who are currently pregnant are excluded from participation. * Significant mental health conditions

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center for Microbiome Research, Microbiomes Institute, University of South Florida, Tampa, FL, 33620

    Tampa, Florida, 33612, United States