An Early Phase 1 interventional study of Botulinum Toxin A (Botox ) in Fecal Incontinence, sponsored by Shaare Zedek Medical Center. Recruiting at 1 site in Israel. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Shaare Zedek Medical Center · Early Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
Drug: Botulinum Toxin A (Botox )
Botulinum Toxin injection
median number of FI episodes/week at 1-month post-intervention compared to baseline
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.
Time frame: 3-months post-intervention
Median number of FI episodes/week at 3-months post-intervention, compared to baseline diary.
Time frame: 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
Rate of patients with daily FI episodes (at least 1 episode/day) compared to baseline.
Time frame: 3-months post-intervention
Mean number of complete bowel movements/week compared to baseline according to diary.
Time frame: 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
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
Plan to share: No
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Shaare Zedek Medical Center