NCT02383758

An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 5 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to try to treat bowel movement (BM) accidents differently with children with autism spectrum disorder (ASD). The study will use over-the-counter (OTC) medications to evoke predictable bowel movements. This will make it possible for investigators to use certain strategies to reward BMs in the toilet. Independence will be increased by fading out the use of medications. The investigators will also train caregivers to implement the procedures.

Detailed description

A large percentage of individuals with autism spectrum disorder (ASD) are delayed in achieving continence with bowel movements or never achieve it at all (i.e., they meet criteria for encopresis). This problem has tremendous ramifications for these individuals and their families because encopresis restricts them from integration with peers, limits access to educational opportunities, and carries significant social stigma. Previous interventions for encopresis in this population have either been unsuccessful or required implementation over very long periods.

Conditions

• Encopresis
• Autistic Disorder

Interventions

Type	Name	Description
DRUG	Glycerin Suppository	Nursing staff will administer one glycerin suppository in the bathroom if there is no continent bowl movement in the first 30 minutes. Subjects will be taken to the bathroom 5 minutes after the suppository is administered for a 30 minute sit or until a continent void occurs. If continent bowel movements maintain on two subsequent days (after bisacodyl suppositories are discontinued) the glycerin suppository will be discontinued. At least one primary caregiver will be trained on all components of intervention still in use on the last day their child's admission. Four weekly follow-up appointments will be used to support them as they continue to implement the protocol at home, including continuing to fade out the use of medications for participants who are at least partially continent but not fully independent at the time of discharge.
DRUG	Bisacodyl suppository	If a subject does not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they will be given a 1 hour break, after which a bisacodyl suppository will be administered. The participant will then sit for an additional 30 minutes.If continent bowel movements maintain for two subsequent days (after senna is discontinued) bisacodyl suppositories will be discontinued if it was required. At least one primary caregiver will be trained on all components of intervention still in use on the last day their child's admission. Four weekly follow-up appointments will be used to support them as they continue to implement the protocol at home, including continuing to fade out the use of medications for participants who are at least partially continent but not fully independent at the time of discharge.
DRUG	Senna	If no continent bowel movements occur for two consecutive treatment days, caregivers will be asked to administer senna each evening thereafter until medication tapering begins. Once there have been two successive days with continent bowel movements, senna will be removed from the intervention if it was required.

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-03-09
• Last updated: 2018-07-02
• Results posted: 2018-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study