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Comprehensive Toileting Program

NCT07226739 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

  • Encopresis
  • ASD

Interventions

DRUG

Glycerin Suppository

Liquid glycerin suppositories, pediatric (age 2-5 years: 4 ml/applicator) or adult (6-12 years: 7.5ml/applicator) dose used as indicated based on age will be used in the study. Up to two doses will be delivered a day. The purpose of the glycerin suppository is to rapidly evoke a bowel movement, which allows for a predictable bowel movement to occur while the child is seated on the toilet (a continent bowel movement).

BEHAVIORAL

Behavioral strategies

The BCBA will provide recommendations on promoting bowel movement continence. The caregiver will be asked to collect data between visits that will be reviewed by the therapist.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Mindy Scheithauer, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2031-01-31
Completion
2031-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07226739 on ClinicalTrials.gov