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Poop pills or tubes: could fecal transplants tame deadly transplant complication?

NCT ID NCT07602751

Disease control Sponsor: Bambino Gesù Hospital and Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving fecal microbiota (from a healthy donor) via a tube or scope into the gut can safely help children and young adults with severe intestinal graft-versus-host disease that hasn't improved with steroids. About 20 participants aged 3 months to 25 years will receive 1 to 3 treatments. The main goal is to check safety, but researchers will also see if it helps control the disease.

What this could mean

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

Active substance
fecal microbiota transplantation
What this could lead to
If successful, this could offer a new treatment option for severe gut graft-versus-host disease that doesn't respond to steroids.
What could go wrong
This is an early-phase pilot study with only 20 participants, so results may not apply broadly. Risks include infection or complications from the procedure.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 20 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

May 2029

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

3 months to 25 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: * Diagnosis of hematological disease, malignant or non-malignant; * Patients undergoing allogeneic stem cell transplantation from a familial or unrelated donor; * Presence of acute GVHD with intestinal involvement (grade II-IV), steroid-resistant (i.e., with progression after 3 days of high-dose steroid therapy (methylprednisolone \> 2 mg/kg), no response after 7 days, progression during steroid tapering, or failure to achieve remission on day 28 from the start of steroid therapy), for those who have no indication for other second- or third-line therapies; * Signed informed consent. Exclusion Criteria: * Presence of concurrent bacterial infections requiring systemic antibiotic therapy; * Positivity for anti-HIV or anti-HCV antibodies, or for HbsAg with HBV-DNA positive by PCR; * Presence of severe mucositis; * History of chronic inflammatory bowel disease.

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease graft versus host disease

As listed by the trial registrant

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

Acute graft versus host disease in intestine

How to take part

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

  1. The places running it

    3 sites. 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

  • Department of Hematology/Oncology, Cell and Gene Therapy, IRCCS Bambino Gesù Children's Hospital

    Roma, 00165, Italy

  • Pediatric Hematology and Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138, Italy

  • UOC Clinica di Oncoematologia Pediatrica, Azienda Ospedale-Università Padova

    Padova, 35128, Italy