NCT06785844 Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study
| NCT ID | NCT06785844 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shaare Zedek Medical Center |
| Condition | Fecal Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 14 participants in total. It began in 2025-07-01 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06785844 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 18 Years, studying Fecal Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06785844 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06785844 currently recruiting?
Yes, NCT06785844 is actively recruiting participants. Contact the research team at dotany@szmc.org for enrollment information.
Where is the NCT06785844 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT06785844 clinical trial?
NCT06785844 is sponsored by Shaare Zedek Medical Center. The trial plans to enroll 14 participants.