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Botox for bowel leaks? small study tests new hope for kids

NCT ID NCT06785844

Symptom relief Sponsor: Shaare Zedek Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study is testing whether injecting Botox into the rectum can help children aged 4-18 who have severe, non-retentive fecal incontinence (leaking stool not caused by constipation). The 14 participants will receive one round of injections and be tracked for 15 weeks to see if accidents become less frequent. It is a small, open-label pilot, so results are preliminary.

What this could mean

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

Active substance
Botulinum toxin A (Botox)
What this could lead to
If it works, this could offer a new treatment option for children with hard-to-treat fecal incontinence.
What could go wrong
This is a very early, small pilot study with only 14 children. It is not placebo-controlled, so results may be less reliable. The treatment may not work or could have side effects.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 14 people

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

Started

Jul 2025

Expected to finish

Sep 2030

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

4 to 18 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: * Children 4-18 years old with fecal incontinence for a period greater than 6 months. * FI frequency of ≥ 3 episodes/week. * After appropriate medical evaluation, FI cannot be explained by another medical condition. * Normal colonic transit study, defined as passage of 80% of markers on day * Normal RAIR on anorectal manometry Exclusion Criteria: * Patients currently fulfilling rome IV criteria for functional constipation. * Patients with evidence of fecal retention. * Patients who had had good response to treatment for overflow incontinence. * Absent RAIR on anorectal manometry. * Any radiologic evidence of dochylosigmoid or distended colon. * Any known organic condition that may affect bowel transit.

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence

As listed by the trial registrant

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

Fecal incontinence

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

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, Israel

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