NCT07226739 Comprehensive Toileting Program
| NCT ID | NCT07226739 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Emory University |
| Condition | Encopresis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2031-01 |
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.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2026-06-01 with a primary completion date of 2031-01.
⚠ 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 current study aims to monitor fecal continence after autistic youth complete enuresis treatment and for individuals who continue to experience encopresis after acquiring urine continence, evaluate a caregiver-mediated version of a Multidisciplinary Intervention for Encopresis (CM-MIE) delivered via telehealth to determine efficacy in a randomized clinical trial.
Eligibility Criteria
Inclusion Criteria * Age 5 to 12 * Diagnosis of an intellectual or developmental delay (excluding individuals with ADHD alone) * Encopresis (more than 1 incontinent BM a week) * Required for pre-randomization phase only: Enuresis (\> 1 incontinent urination per day when on a consistent toileting sit schedule) * At least one caregiver who speaks and understands English Exclusion Criteria: * Unresolved medical condition that would impede toilet training (e.g., interference with sphincter control, short gut syndrome, urinary tract or gastrointestinal infection, unexplained diarrhea, recent intestinal surgery, inflammatory bowel disease) * Failed intensive toileting treatment in the past 2 yrs with protocols akin to study * Current serious behavioral or psychiatric disorder that requires another treatment * Current or planned other intervention (behavioral or medical) for incontinence
Contact & Investigator
Mindy Scheithauer, PhD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT07226739 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 12 Years, studying Encopresis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07226739 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07226739 currently recruiting?
Yes, NCT07226739 is actively recruiting participants. Contact the research team at Mindy.Scheithauer@choa.org for enrollment information.
Where is the NCT07226739 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT07226739 clinical trial?
NCT07226739 is sponsored by Emory University. The principal investigator is Mindy Scheithauer, PhD at Emory University. The trial plans to enroll 150 participants.