Last updated: January 5, 2024
Sponsor: Emory University
Overall Status: Completed
Phase
3
Condition
Fecal Incontinence
Asperger's Disorder
Autism Spectrum Disorder (Asd)
Treatment
MIE Treatment
Treatment as Usual (TAU)
Glycerin Suppository
Clinical Study ID
NCT03197922
IRB00095849
Ages 5-12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Males and females from 5 years of age to 12 years 11 months of age.
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of AutismSpectrum Disorder as established by clinical assessment, corroborated by the AutismDiagnostic Observational Schedule, Autism Diagnostic Interview-Revised and/orChildhood Autism Rating Scale-Second Edition.
- Fewer than 60% of days are continent days or more than 1 day out of 7 is anincontinent day over the previous 7 days (a continent day is defined as a day with atleast one continent bowel movement. An incontinent day is a day with an incontinentbowel movement regardless of whether a continent bowel movement also occurs).
- Medication free or on stable medication (no changes in past 6 weeks and no plannedchanges for the next 6 months).
- Urine continent - Over half of the voids are continent when the child is with theparent and when the child is on a typical toileting routine.
Exclusion
Exclusion Criteria:
- Presence of a known medical condition in the child (based on medical history orphysical examination) that would interfere with child's ability to control his/heranus. These include: history of any anal surgery, spinal dysraphism (e.g., spinabifida), other neurologic disorder affecting anal function, and prolonged/recurrentgastrointestinal infectious disease (e.g. Clostridium difficile colitis). In addition,the following may constitute exclusions following evaluation by a physician:inflammatory bowel disease, short gut syndrome, chronic diarrhea, or history ofintestinal/abdominal surgery.
- Presence of a current serious behavioral problem or psychiatric condition that wouldrequire another treatment (e.g., psychotic disorder, major depression, moderate orgreater aggression, severe disruptive behavior), based on information collected atscreening and the Behavior Problems Inventory-01 (BPI-01).
- Currently receiving and caregiver refusal to discontinue ongoing behavioral oralternative medical intervention for encopresis.
Study Design
Total Participants: 117
Treatment Group(s): 4
Primary Treatment: MIE Treatment
Phase: 3
Study Start date:
October 25, 2017
Estimated Completion Date:
November 17, 2022
Study Description
Connect with a study center
Marcus Autism Center
Atlanta, Georgia 30329
United StatesSite Not Available
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