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Could a poop pill tame inflammation? new trial tests FMT for arthritis and bowel disease

NCT ID NCT04924270

Disease control Sponsor: Odense University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether fecal microbiota transplants (FMT) given as capsules can safely improve symptoms in people newly diagnosed with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's disease, or ulcerative colitis. Two hundred participants will receive either FMT or a placebo weekly for a month, along with standard anti-inflammatory treatment. The goal is to see if adding FMT helps control disease better than standard care alone.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

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

Started

Dec 2023

Expected to finish

Dec 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 to 75 years

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: * Newly diagnosis of treatment-naïve RA, AS, PsA, PSar, CD, or UC. * Treatment-naïve which is defined as no current or previous (within 3 months) disease-modifying anti-rheumatic drugs (DMARDs) or systemic anti-inflammatory treatment including glucocorticoids. * Presence of CID treatment indication (no contra-indications) and patient accept to start first-line standard treatment in accordance with the national guideline for the specific diagnosis following the baseline visit. * Age 18 to 75 years. Exclusion criteria: * Indication for biological therapy as primary therapy. * Celiac disease or food allergy. * Current cancer. * Hepatitis B and C, HIV, HTLV1/2, and active TB or other serious chronic infections. * Pregnant or breastfeeding women. * Not wishing to participate or not suited for FMT intervention or project evaluation.

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis Crohn disease psoriatic arthritis pulmonary sarcoidosis rheumatoid arthritis ulcerative colitis

As listed by the trial registrant

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

Ankylosing spondylitis Crohn disease Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis

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

  • Odense University Hospital

    RECRUITING

    Odense, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.