Trial Outcomes & Findings for An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders (NCT NCT02383758)
NCT ID: NCT02383758
Last Updated: 2018-07-02
Results Overview
The percentage of participant's with continent bowel movements (control of passage of stool from the bowel).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)
Results posted on
2018-07-02
Participant Flow
Participants were recruited between February 2015 and January 2017.
Of the 22 subjects consented for participation, 20 were randomized to a study intervention and were included in study analyses.
Participant milestones
| Measure |
Treatment Program
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.
|
Waitlist Control
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 Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Treatment Program
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.
|
Waitlist Control
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 Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Program
n=10 Participants
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.
|
Waitlist Control
n=10 Participants
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
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
16 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)Population: An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.
The percentage of participant's with continent bowel movements (control of passage of stool from the bowel).
Outcome measures
| Measure |
Treatment Program
n=10 Participants
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.
|
Waitlist Control
n=10 Participants
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.
|
|---|---|---|
|
Percent Continent
Baseline
|
0 percentage of participants
|
0 percentage of participants
|
|
Percent Continent
Post-Intervention (Week 2)
|
6 percentage of participants
|
0 percentage of participants
|
|
Percent Continent
Follow Up (Week 4)
|
5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)Population: An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.
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.
Outcome measures
| Measure |
Treatment Program
n=10 Participants
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.
|
Waitlist Control
n=10 Participants
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.
|
|---|---|---|
|
Percent Independence
Baseline
|
0 percentage of participants
|
0 percentage of participants
|
|
Percent Independence
Post-Intervention (Week 2)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percent Independence
Follow Up (week 4)
|
5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10)Population: An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.
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
Outcome measures
| Measure |
Treatment Program
n=10 Participants
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.
|
Waitlist Control
n=10 Participants
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.
|
|---|---|---|
|
Mean Clinical Global Impression for Severity (CGI-S) Score
Baseline
|
5.4 units on a scale
Standard Deviation .7
|
5.2 units on a scale
Standard Deviation .4
|
|
Mean Clinical Global Impression for Severity (CGI-S) Score
Post-Intervention (Week 6)
|
5.0 units on a scale
Standard Deviation .9
|
5.0 units on a scale
Standard Deviation .5
|
|
Mean Clinical Global Impression for Severity (CGI-S) Score
Post-Intervention (Week 10)
|
4.3 units on a scale
Standard Deviation .9
|
4.9 units on a scale
Standard Deviation .6
|
SECONDARY outcome
Timeframe: Post-Intervention (Week 6), Post-Intervention (Week 10)Population: An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.
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.
Outcome measures
| Measure |
Treatment Program
n=10 Participants
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.
|
Waitlist Control
n=10 Participants
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.
|
|---|---|---|
|
Mean Clinical Global Impression for Improvement (CGI-I) Score
Post-Intervention (Week 6)
|
3.0 units on a scale
Standard Deviation .5
|
3.8 units on a scale
Standard Deviation .6
|
|
Mean Clinical Global Impression for Improvement (CGI-I) Score
Post-Intervention (Week 10)
|
2.1 units on a scale
Standard Deviation .9
|
3.6 units on a scale
Standard Deviation 1.0
|
Adverse Events
Treatment Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place