EncopresisNCT02383758
An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
A study testing Glycerin Suppository, Bisacodyl suppository and Senna in people with Encopresis and Autistic Disorder, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Encopresis, Autistic Disorder
- What is being tested?
- Glycerin Suppository, Bisacodyl suppository and Senna
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2015to 1 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 5-21
- Confirmed diagnosis of autistic spectrum disorder using the Social Communication Questionnaire (SCQ) and the Childhood Autism Rating Scale II (CARSII)
- Clearance from gastroenterologist for use of glycerin suppository, bisacodyl suppository and senna
- Caregiver willing to give consent/assent
Who cannot join
- Age under 5 year or over 21 years
- Does not present a diagnosis of autistic spectrum disorder
- Previous intestinal surgeries or concurrent enuresis
- Caregiver unwilling to give consent/assent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Glycerin Suppository, Bisacodyl suppository, Senna
- Keywords
- Behavioral Symptoms, Child Development Disorders, Pervasive, Bowel Incontinence, Constipation
- Medical subject headings
- Encopresis, Autistic Disorder, Behavioral Symptoms, Child Development Disorders, Pervasive, Fecal Incontinence, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycerin SuppositoryDrug
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.
Bisacodyl suppositoryDrug
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.
SennaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Program | Experimental | Pediatric subjects with autistic spectrum disorder will begin treatment immediately. The treatment program will consist of 10 appointments of up to 4 hours each, over a 14 day period, followed by 4 weekly 1-hour follow-up visits. During each appointment, subjects will be guided to sit on the toilet. If the participant has a continent urination they will be provided with praise and remain on the toilet. If a participant has a continent bowel movement they will be provided with enthusiastic praise along with positive reinforcement and they will be allowed to leave the bathroom. A continent bowel movement will end that day's appointment. If necessary, glycerin suppositories, bisacodyl suppositories, and/or senna may be used to aid in the bowl movement. Receives: Drug: Glycerin Suppository; Drug: Bisacodyl suppository; Drug: Senna |
| Waitlist Control | Active comparator | Pediatric subjects with autistic spectrum disorder will wait for 8 weeks and then be offered treatment at that time.The treatment program will consist of 10 appointments of up to 4 hours each, over a 14 day period, followed by 4 weekly 1-hour follow-up visits. During each appointment, participants will be guided to sit on the toilet. If the participant has a continent urination they will be provided with praise and remain on the toilet. If a participant has a continent bowel movement they will be provided with enthusiastic praise along with positive reinforcement and they will be allowed to leave the bathroom. A continent bowel movement will end that day's appointment. If necessary, glycerin suppositories, bisacodyl suppositories, and/or senna may be used to aid in the bowl movement. Receives: Drug: Glycerin Suppository; Drug: Bisacodyl suppository; Drug: Senna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Continent
The percentage of participant's with continent bowel movements (control of passage of stool from the bowel).
Measured: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)
Secondary outcomes (3)
Percent Independence
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.
Measured: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)
Mean Clinical Global Impression for Severity (CGI-S) Score
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
Measured: Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10)
Mean Clinical Global Impression for Improvement (CGI-I) Score
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.
Measured: Post-Intervention (Week 6), Post-Intervention (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study start1 Feb 2015
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EncopresisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Organization for Autism Research
- Responsible party
- Principal investigator, Nathan A. Call, Ph.D., BCBA-D, Emory University
- Investigators
- Nathan Call, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383758
- Sponsor's protocol ID
- IRB00076608
- Status last verified
- May 2018
- First submitted
- 25 Feb 2015
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02383758
- Acronym / sponsor ID
- IRB00076608
- Conditions
- Encopresis, Autistic Disorder
- Keywords
- Behavioral Symptoms, Child Development Disorders, Pervasive, Bowel Incontinence, Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Organization for Autism Research
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Posted 11 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Program | Experimental | Drug: Glycerin Suppository, Drug: Bisacodyl suppository, Drug: SennaPediatric subjects with autistic spectrum disorder will begin treatment immediately. The treatment program will consist of 10 appointments of up to 4 hours each, over a 14 day period, followed by 4 weekly 1-hour follow-up visits. During each appointment, subjects will be guided to sit on the toilet. If the participant has a continent urination they will be provided with praise and remain on the toilet. If a participant has a continent bowel movement they will be provided with enthusiastic praise along with positive reinforcement and they will be allowed to leave the bathroom. A continent bowel movement will end that day's appointment. If necessary, glycerin suppositories, bisacodyl suppositories, and/or senna may be used to aid in the bowl movement. |
| Waitlist Control | Active comparator | Drug: Glycerin Suppository, Drug: Bisacodyl suppository, Drug: SennaPediatric subjects with autistic spectrum disorder will wait for 8 weeks and then be offered treatment at that time.The treatment program will consist of 10 appointments of up to 4 hours each, over a 14 day period, followed by 4 weekly 1-hour follow-up visits. During each appointment, participants will be guided to sit on the toilet. If the participant has a continent urination they will be provided with praise and remain on the toilet. If a participant has a continent bowel movement they will be provided with enthusiastic praise along with positive reinforcement and they will be allowed to leave the bathroom. A continent bowel movement will end that day's appointment. If necessary, glycerin suppositories, bisacodyl suppositories, and/or senna may be used to aid in the bowl movement. |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 5-21
- Confirmed diagnosis of autistic spectrum disorder using the Social Communication Questionnaire (SCQ) and the Childhood Autism Rating Scale II (CARSII)
- Clearance from gastroenterologist for use of glycerin suppository, bisacodyl suppository and senna
- Caregiver willing to give consent/assent
Key exclusion criteria (4 listed)
- Age under 5 year or over 21 years
- Does not present a diagnosis of autistic spectrum disorder
- Previous intestinal surgeries or concurrent enuresis
- Caregiver unwilling to give consent/assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycerin SuppositoryNursing 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 | Treatment Program, Waitlist Control |
| Bisacodyl suppositoryIf 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 | Treatment Program, Waitlist Control |
| SennaIf 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. | Drug | Treatment Program, Waitlist Control |
Primary outcome
Percent Continent
Time frame: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)
The percentage of participant's with continent bowel movements (control of passage of stool from the bowel).
3 secondary outcomes
Percent Independence
Time frame: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)
Mean Clinical Global Impression for Severity (CGI-S) Score
Time frame: Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10)
Mean Clinical Global Impression for Improvement (CGI-I) Score
Time frame: Post-Intervention (Week 6), Post-Intervention (Week 10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Encopresis
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Fecal Incontinence
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Call, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycerin Suppository, Bisacodyl suppository and Senna in people with Encopresis and Autistic Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Continent (time frame: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.