Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02383758
Recruitment Status : Completed
First Posted : March 9, 2015
Results First Posted : January 11, 2018
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
Organization for Autism Research
Information provided by (Responsible Party):
Nathan A. Call, Ph.D., BCBA-D, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Encopresis
Autistic Disorder
Interventions Drug: Glycerin Suppository
Drug: Bisacodyl suppository
Drug: Senna
Enrollment 22
Recruitment Details Participants were recruited between February 2015 and January 2017.
Pre-assignment Details Of the 22 subjects consented for participation, 20 were randomized to a study intervention and were included in study analyses.
Arm/Group Title Treatment Program Waitlist Control
Hide Arm/Group Description

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Period Title: Overall Study
Started 10 10
Completed 10 8
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Arm/Group Title Treatment Program Waitlist Control Total
Hide Arm/Group Description

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
Participants randomized to an intervention arm.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
10
 100.0%
10
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
0
   0.0%
4
  40.0%
4
  20.0%
Male
10
 100.0%
6
  60.0%
16
  80.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Percent Continent
Hide Description The percentage of participant's with continent bowel movements (control of passage of stool from the bowel).
Time Frame Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)
Hide Outcome Measure Data
Hide Analysis Population Description
An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.
Arm/Group Title Treatment Program Waitlist Control
Hide Arm/Group Description:

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 0 0
Post-Intervention (Week 2) 6 0
Follow Up (Week 4) 5 0
2.Secondary Outcome
Title Percent Independence
Hide Description Percent independence is the percentage of independent bowel movements recorded by a caregiver. A continent bowel movement without the use of any medications will constitute an independent bowel movement.
Time Frame Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)
Hide Outcome Measure Data
Hide Analysis Population Description
An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.
Arm/Group Title Treatment Program Waitlist Control
Hide Arm/Group Description:

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 0 0
Post-Intervention (Week 2) 0 0
Follow Up (week 4) 5 0
3.Secondary Outcome
Title Mean Clinical Global Impression for Severity (CGI-S) Score
Hide Description An independent evaluator (IE) will use the parent target problem (PTP) interview to help caregivers estimate the frequency of encopresis as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant’s encopresis. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Severity (CGI-S). Clinical Global Impression of Severity (CGI-S) Scale is a clinician’s assessment of patient’s severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients
Time Frame Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10)
Hide Outcome Measure Data
Hide Analysis Population Description
An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.
Arm/Group Title Treatment Program Waitlist Control
Hide Arm/Group Description:

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.4  (.7) 5.2  (.4)
Post-Intervention (Week 6) 5.0  (.9) 5.0  (.5)
Post-Intervention (Week 10) 4.3  (.9) 4.9  (.6)
4.Secondary Outcome
Title Mean Clinical Global Impression for Improvement (CGI-I) Score
Hide Description An independent evaluator (IE) will use the parent target problem (PTP) interview to help caregivers estimate the frequency of encopresis as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's encopresis. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Improvement (CGI-I). Clinical Global Impression for Improvement (CGI-I) Scale is a clinician's assessment of a patient's change in condition from baseline.The score ranges from 0 = not assessed, 1 = very much improved, through 7 = very much worse.
Time Frame Post-Intervention (Week 6), Post-Intervention (Week 10)
Hide Outcome Measure Data
Hide Analysis Population Description
An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.
Arm/Group Title Treatment Program Waitlist Control
Hide Arm/Group Description:

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Post-Intervention (Week 6) 3.0  (.5) 3.8  (.6)
Post-Intervention (Week 10) 2.1  (.9) 3.6  (1.0)
Time Frame Adverse events were collected throughout the duration of the study (1 year and 11 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Program Waitlist Control
Hide Arm/Group Description

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.

Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.

Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.

Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.

All-Cause Mortality
Treatment Program Waitlist Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Program Waitlist Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Program Waitlist Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
This is a pilot trial with a limited sample size. Outcome measure percent change in the number of bowel movements/day was adjusted due to percentage of patients continent due to most participants having no bowel movements at baseline.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Nathan Call
Organization: Emory University
Responsible Party: Nathan A. Call, Ph.D., BCBA-D, Emory University
ClinicalTrials.gov Identifier: NCT02383758     History of Changes
Other Study ID Numbers: IRB00076608
First Submitted: February 25, 2015
First Posted: March 9, 2015
Results First Submitted: December 14, 2017
Results First Posted: January 11, 2018
Last Update Posted: July 2, 2018