Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study
Recruiting
Early Phase 1
Interventional Study
Fecal Incontinence
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 4 – 18
- Sex
- Any
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 14 (estimated)
- Sponsor
- Shaare Zedek Medical Center · Other
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About This Trial
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 fo…
Trial Locations
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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 ma…
Contacts