Botulinum Toxin Injection for Children Aged 4 to 18 with Persistent Non-retentive Fecal Incontinence An Open-label Pilot Study Evaluating Safety and Efficacy

What this Trial Is About

Researchers are evaluating the use of rectal botulinum toxin injections as a treatment for children aged 4 to 18 years who experience non-retentive fecal incontinence NRFI, a common and distressing gastrointestinal condition. This early phase 1 study aims to assess the safety and effectiveness of this treatment in children, addressing a significant need due to limited options for those whose fecal incontinence is not caused by constipation. The study is sponsored by Shaare Zedek Medical Center and focuses on children with persistent NRFI lasting more than six months. Participants will receive a single course of rectal botulinum toxin A injection after being screened with anorectal manometry and a colonic transit study to confirm eligibility. The treatment involves one injection session, and data on fecal incontinence episodes will be collected over a 15-week period following the injection. This open-label pilot study does not include a placebo or comparison group. During the study, children will be closely monitored for changes in the frequency of fecal incontinence using diaries and clinical assessments. Researchers will evaluate the median number of fecal incontinence episodes per week at one and three months after treatment compared to baseline. Safety will be assessed by tracking any major or minor adverse events related to the injection. The total study duration for each participant encompasses screening, treatment, and follow-up over several months.

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