Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study

January 21, 2025 updated by: Yogev Dotan, Shaare Zedek Medical Center

Background: Fecal Incontinence (FI) is a frustrating and prevalent GI condition with profound social implications and a marked effect on quality of life. Treatment options are limited for children whose FI is not secondary to constipation (overflow incontinence), and they are defined as having non-retentive fecal incontinence (NRFI). Rectal botulinum injections (RBI) have recently shown promise for the treatment of FI in adults, following a large, randomized placebo-controlled trial, but no data exists regarding efficacy in children.

Objectives: To evaluate the efficacy and safety of RBI in children with non-retentive fecal incontinence.

Methods: A prospective open-label pilot study. Children with intractable NRFI will be screened using anorectal manometry and a colonic transit study. Eligible patients will receive one course of RBI and data regarding FI frequency will be prospectively collected during a 15-week period.

Significance: New treatment options for children with intractable fecal incontinence are highly in need. The current study aims to introduce a new treatment modality into pediatric research and patient care.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botulinum toxin
Drug: Botulinum Toxin A (Botox )
Botulinum Toxin injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
median number of FI episodes/week at 1-month post-intervention compared to baseline
Time Frame: 3-months post-intervention
median number of FI episodes/week at 1-month post-intervention compared to baseline. The median FI episodes/week will be calculated based on the 21-day diary. FI episode minimal definition: any episode of soiling requiring change of underwear/clothes/washing-up.
3-months post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Median number of FI episodes/week at 3-months post-intervention, compared to baseline diary.
Time Frame: 3-months post-intervention
3-months post-intervention
Rate of patients with a 50% decrease in mean FI episodes/week compared to baseline diary.
Time Frame: 3-months post-intervention
3-months post-intervention
Rate of patients with daily FI episodes (at least 1 episode/day) compared to baseline.
Time Frame: 3-months post-intervention
3-months post-intervention
Mean number of complete bowel movements/week compared to baseline according to diary.
Time Frame: 3-months post-intervention
3-months post-intervention
Parents and patient's general impression of the treatment using the following questions: "Was the treatment useful/beneficial?"; "Did the treatment improve your quality of life"?
Time Frame: 3-months post-intervention
3-months post-intervention
Rate of RBI-associated major and minor adverse events. Patients will be questioned according to list, as well as allowed to add adverse events not listed.
Time Frame: 3-months post-intervention
3-months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intra-rectal Botulinum toxin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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