NCT05253196 Enema Device for Children With Spina Bifida
| NCT ID | NCT05253196 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Spina Bifida |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-08-11 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-08-11 with a primary completion date of 2028-08.
⚠ 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
The International Center for Colorectal and Urogenital Care at Children's Hospital Colorado treats patients who suffer from many different colorectal issues such as anorectal malformation, Hirschsprung disease, and severe constipation. Many of these patients suffer from fecal incontinence. The investigators have developed a week long bowel management program (BMP) that is offered every month to help these kids stay clean of stool in the underwear, by finding the perfect enema recipe to clean the colon for 24 hours. This allows one to perform an enema once every day, clean their colon, and remain free of 'accidents'. Many spina bifida patients also suffer from fecal incontinence and are referred to this BMP. The overall success rate for all patients who suffer from fecal incontinence is 95%, however the success rate for spina bifida patients is only 77%. The reason for this decrease in success is due to the lack of anal sphincter tone in spina bifida patients, which leads to inadvertent leakage and spillage of enema fluid and bowel content during enema administration. The purpose of this study is to create and test an enema administration device that improves upon current methods.
Eligibility Criteria
Inclusion Criteria: * Poor sphincter tone * Perform regular enemas for bowel management (due to fecal incontinence) * 2 - 30 years old Exclusion Criteria: * Non English speakers * Prisoners * Pregnant women * Wards of state * Decisionally challenged adults
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05253196 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 30 Years, studying Spina Bifida. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05253196 currently recruiting?
Yes, NCT05253196 is actively recruiting participants. Contact the research team at Jill.Ketzer@childrenscolorado.org for enrollment information.
Where is the NCT05253196 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05253196 clinical trial?
NCT05253196 is sponsored by University of Colorado, Denver. The trial plans to enroll 20 participants.