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New treatment option for Fecal Incontinence
Official title Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study
ClinicalTrials.gov ID: NCT06785844
What this study is testing
What is Botulinum Toxin A (Botox )?
Botulinum Toxin A (Botox ) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for fecal incontinence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 18
You may be able to join if
- 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
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.