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Poop pills for kids? new study tests fecal transplants against stubborn gut infections

NCT ID NCT02636517

Disease control Sponsor: Judith Kelsen 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a fecal transplant (FMT) can safely and effectively treat recurrent C. difficile infections in children, including those with inflammatory bowel disease (IBD). Researchers will give FMT to 250 children aged 3-21 and track whether the infection comes back. The goal is to see if FMT works better than standard antibiotics.

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 250 people

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

Start date

Dec 2015

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

3 to 21 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: 1. Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic measures, as per standard protocol. 2. Age ≥ 3 years old. 3. Recurrent C. difficile or Moderate to Severe C. difficile. 4. Satisfactory completion of the medical interview and physical exam conducted by a study team member 5. Participants must be between 3 and 21 years of age (inclusive) 6. Signed informed consent form, and assent (if applicable) Exclusion Criteria: 1. Patients \<3 years old 2. Patients with other co-morbid intestinal infectious processes 3. Recipients with a history of severe (anaphylactic) food allergy 4. If female, participants of childbearing potential (females aged 11 and older or those who have already begun menstruating) will be required to have a urine pregnancy test on the day of the FMT procedure. Patients who are pregnant will not be enrolled. 5. Patients with severe IBD. 6. Ongoing/anticipated antibiotic use for non-CDI indication 7. Adverse event attributable to a previous FMT 8. Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS) 9. Any other condition for which the treating physician thinks the treatment may pose a health risk 10. Predicted death within time period of follow-up 11. Patients who are on supraphysiologic doses of corticosteroids

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Clostridium difficile Crohn's disease Inflammatory bowel disease 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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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