MIE Treatment for Two Weeks for Autism Spectrum Disorders

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Autism Spectrum Disorders+5 More
MIE Treatment - CombinationProduct
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new intervention for encopresis (poop accidents) in children with autism spectrum disorder. The intervention is a combination of medical and behavioral treatment, and the researchers are testing it against usual care. The goal is to see if the new intervention is more effective than usual care and to determine how long the intervention should last.

Eligible Conditions
  • Autism Spectrum Disorders
  • Autism Spectrum Disorder
  • Encopresis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Autism Spectrum Disorders

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Week 8, Week 28

Baseline, Week 8
Caregiver Strain Questionnaire
Change in Caregiver Strain Questionnaire - Short Form Score
Change in Continence
Change in Parenting Stress Index Short Form Score
Week 28
Caregiver Strain Questionnaire MIE-1 vs. MIE-2
Week 8
Clinical Global Impression Scale - Improvement (CGI-I) Score
Number of Children Achieving Continence
Week 8, Week 28
Change in Continence between MIE-1 vs MIE-2
Change in Independence between MIE-1 vs. MIE-2
Clinical Global Impression Scale - Improvement (CGI-I) Score between MIE-1 vs. MIE-2

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Autism Spectrum Disorders

Trial Design

3 Treatment Groups

Treatment as Usual (TAU)
1 of 3
MIE Treatment for Two Weeks
1 of 3
MIE Treatment for One Week
1 of 3
Active Control
Experimental Treatment

138 Total Participants · 3 Treatment Groups

Primary Treatment: MIE Treatment for Two Weeks · No Placebo Group · Phase 3

MIE Treatment for Two Weeks
CombinationProduct
Experimental Group · 1 Intervention: MIE Treatment · Intervention Types: CombinationProduct
MIE Treatment for One Week
CombinationProduct
Experimental Group · 1 Intervention: MIE Treatment · Intervention Types: CombinationProduct
Treatment as Usual (TAU)NoIntervention Group · 1 Intervention: Treatment as Usual (TAU) · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 8, week 28

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,501 Previous Clinical Trials
2,677,418 Total Patients Enrolled
United States Department of DefenseFED
767 Previous Clinical Trials
202,267 Total Patients Enrolled
Nathan Call, PhDPrincipal InvestigatorEmory University
4 Previous Clinical Trials
454 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A person is diagnosed with Autism Spectrum Disorder if they show symptoms of autism as determined by a clinical assessment and corroborated by other diagnostic tools.
Males and females who are aged between 5 and 12 years and 11 months.
Sixty percent of days or fewer are continent days, with more than one day out of seven being an incontinent day over the previous seven days.
Patients taking no medication or stable medication (no changes in past 6 weeks and no planned changes for the next 6 months).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.