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

RecruitingEARLY Phase 1Ages 4 Years - 18 YearsAllShaare Zedek Medical Center
NCT06785844 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Botulinum Toxin A (Botox )
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Where

1 site
Shaare Zedek Medical Center
Jerusalem, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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