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Could a gut makeover help Alzheimer's? first safety trial begins

NCT ID NCT07332260

Symptom relief Sponsor: University Hospital of North Norway Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study is testing whether a fecal microbiota transplant (FMT) is safe and feasible for people with mild-to-moderate Alzheimer's disease. Ten participants will receive the transplant via colonoscopy, and researchers will monitor side effects, recruitment rates, and changes in gut bacteria. The goal is to see if this approach is worth studying further for easing Alzheimer's symptoms.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

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: * Alzheimer's dementia mild to moderate stage * Presence of Alzheimer pathology core 1 biomarkers as defined by National Institute on Aging-Alzheimer's Association (NIA-AA) criteria (2024) * Capable of giving informed consent Exclusion Criteria: * Contraindications for colonoscopy examination * Contraindications for Magnetic Resonance Imaging (MRI) * Life expectancy \< 1 year * Clinical frailty scale 7 or more * History of seizure disorder * History of brain tumour or intracranial bleed * Major psychiatric disorder such as schizophrenia, bipolar disorder, or major depressive disorder * Alcohol or substance abuse * Decompensated heart disease * Malignancy * Current use of anticoagulant treatment (dual acting oral anticoagulant or warfarin) * Pregnant or planning pregnancy * Colonic adenomas over 1 cm, tumours or signs of active colitis on colonoscopy * Status after colectomy or hemicolectomy * Inflammatory bowel disease * Immunocompromised individual * Receiving biological/antibody treatment

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Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia

As listed by the trial registrant

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

Alzheimer's disease Faecal microbiota transplantation (FMT)

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

  • University Hospital of North Norway, Tromsø

    RECRUITING

    Tromsø, Troms, 9016, Norway

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