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NCT Number: NCT06785844

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

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum Toxin A (Botox )

Drug

Botulinum Toxin injection

Primary outcomes

  1. 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.

Secondary outcomes

  1. Median number of FI episodes/week at 3-months post-intervention, compared to baseline diary.

    Time frame: 3-months post-intervention

  2. Rate of patients with a 50% decrease in mean FI episodes/week compared to baseline diary.

    Time frame: 3-months post-intervention

  3. Rate of patients with daily FI episodes (at least 1 episode/day) compared to baseline.

    Time frame: 3-months post-intervention

  4. Mean number of complete bowel movements/week compared to baseline according to diary.

    Time frame: 3-months post-intervention

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dotan Yogev, MD

CONTACT

[email protected]

97225645027

Zivia Shavit, MSc

CONTACT

[email protected]

972542520204

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jan 21, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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