EncopresisPhase 4NCT07226739
Comprehensive Toileting Program
A Phase 4 study testing Glycerin Suppository and Behavioral strategies in people with Encopresis and ASD, run by Emory University at 1 site in United States.
Trial summary
The current study aims to monitor fecal continence after autistic youth complete enuresis treatment and for individuals who continue to experience encopresis after acquiring urine continence, evaluate a caregiver-mediated version of a Multidisciplinary Intervention for Encopresis (CM-MIE) delivered via telehealth to… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Encopresis, ASD
- What is being tested?
- Glycerin Suppository and Behavioral strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to Jan 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5 to 12
- Diagnosis of an intellectual or developmental delay (excluding individuals with ADHD alone)
- Encopresis (more than 1 incontinent BM a week)
- Required for pre-randomization phase only: Enuresis (> 1 incontinent urination per day when on a consistent toileting sit schedule)
- At least one caregiver who speaks and understands English
Who cannot join
- Unresolved medical condition that would impede toilet training (e.g., interference with sphincter control, short gut syndrome, urinary tract or gastrointestinal infection, unexplained diarrhea, recent intestinal surgery, inflammatory bowel disease)
- Failed intensive toileting treatment in the past 2 yrs with protocols akin to study
- Current serious behavioral or psychiatric disorder that requires another treatment
- Current or planned other intervention (behavioral or medical) for incontinence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Marcus Autism Center
Atlanta, Georgia, 30329
Mindy Scheithauer, PhD, mindy.scheithauer@emory.edu
About this study
Official title: Comprehensive Toileting Programming: Enuresis Treatment to a Randomized Clinical Trial of a Caregiver-Mediated Multidisciplinary Intervention for Encopresis
The current study aims to monitor fecal continence after autistic youth complete enuresis treatment and for individuals who continue to experience encopresis after acquiring urine continence, evaluate a caregiver-mediated version of a Multidisciplinary Intervention for Encopresis (CM-MIE) delivered via telehealth to determine efficacy in a randomized clinical trial.
Read the detailed description
Participants will complete toilet training for enuresis (if needed) and then monitored to determine if encopresis persists. For individuals with resolved enuresis but persisting encopresis, they will be randomized to receive either a treatment for encopresis (delivered via telehealth) or a parent education program. The encopresis intervention involves behavioral components and administration of an over-the-counter suppository as needed. All participants will also meet with a pediatric gastroenterologist to ensure safety of study procedures and to resolve constipation as needed. Outcomes will include caregiver-completed questionnaires, data on bowel movements collected by the caregiver, and an interview between the participant's caregiver and a blinded investigator focused on encopresis, other presenting concerns, and any potential adverse events.
Informed consent will be collected via signature from one legal guardian. The investigators will collect assent from participants when appropriate given age and developmental level.
- Conditions
- Encopresis, ASD
- Being tested
- Glycerin Suppository, Behavioral strategies
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycerin SuppositoryDrug
Also called MAJOR® Glycerin
Liquid glycerin suppositories, pediatric (age 2-5 years: 4 ml/applicator) or adult (6-12 years: 7.5ml/applicator) dose used as indicated based on age will be used in the study. Up to two doses will be delivered a day.
The purpose of the glycerin suppository is to rapidly evoke a bowel movement, which allows for a predictable bowel movement to occur while the child is seated on the toilet (a continent bowel movement).
Behavioral strategiesBehavioural
The BCBA will provide recommendations on promoting bowel movement continence. The caregiver will be asked to collect data between visits that will be reviewed by the therapist.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver-mediated version of multidisciplinary intervention for encopresis (CM-MIE) Arm | Experimental | * A Board-Certified Behavior Analyst (BCBA) will meet virtually with caregivers for daily appointments for two weeks (goal of 10 appointments; maximum of 2-hours per appointment).
* First appointment, the BCBA will provide support on using telehealth and psychoeducation about encopresis, reinforcement, and suppository use.
* Subsequent appointments involve a scheduled sit on the toilet to encourage an independent bowel movement. If a bowel movement occurs, the caregiver is coached to provide the child with a highly preferred item, praise, and allow them to leave the bathroom. If a bowel movement does not occur, the therapist coaches the parent through administration of a glycerin suppository intended to quickly elicit a bowel movement, followed by another scheduled sit on the toilet.
* After consistent success with continent BMs following suppository administration, the suppository dose will be reduced to gradually fade out its use. Receives: Drug: Glycerin Suppository; Behavioral: Behavioral strategies |
| Parent Education (PE) Arm | Active comparator | * PE includes an initial appointment with a BCBA who will provide recommendations on promoting bowel movement continence.
* First appointment will involve a didactic review of the basics of reinforcement, collecting data to identify when BMs are most likely, and scheduled sits around this time. Caregivers will be instructed to collect data on BMs after this appointment.
* The BCBA will then hold daily follow-up appointments (10 appointments total over 2 weeks). At these appointments, the BCBA will review this data and make additional recommendations (e.g., changing the timing of scheduled sits based on when BMs are most likely to occur, altering the reinforcer used for continent voids) to promote success. Receives: Behavioral: Behavioral strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression Improvement (CGI-I) scale score
The CGI-I is a clinician-rated 7-point scale measuring overall change from baseline. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse), rated by the treatment-blind independent evaluator (IE) with all available information. CGI-I ratings of Much Improved (score of 2) or Very Much Improved (score of 1) will define positive response; all other ratings are defined as nonresponders. Number of positive responses for the Clinical Global Impression scale will be compared between the CM-MIE and the PE group.
Measured: 5 weeks post-baseline (Endpoint)
Secondary outcomes (2)
Caregiver Strain Questionnaire-short form (CGSQ-SF) score
Caregiver Strain Questionnaire-short form (CGSQ-SF) change score at endpoint will be compared between the CM-MIE and the PE group.
The Caregiver Strain Questionnaire-short form is a 7-item measure of self-reported strain experienced by caregivers and families, with responses on a 5-point Likert scale. Total possible score range is 7-35, with higher scores indicating higher strain (worse outcome).
Measured: 5 weeks post-baseline (Endpoint)
Fecal continence based on caregiver-collected data
Treatment response measured as fecal continence based on caregiver-collected data in a bowel-activity diary that documents all continent and incontinent bowel movements. Number of positive responses will be compared in CM-MIE vs. PE groups.
Measured: 5 weeks post-baseline (Endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start1 Jun 2026
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Mindy Scheithauer, Emory University
- Investigators
- Mindy Scheithauer, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226739
- Sponsor's protocol ID
- STUDY00010223
- Other IDs
- 1R01HD115933-01A1, 2025P012749
- Status last verified
- Jun 2026
- First submitted
- 7 Nov 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The below information will all be shared through NIMH Data Archive (NDA): 1. Diagnostic information 2. Scores from developmental measures (e.g., ADOS or CARS) 3. Vineland Adaptive Behavior Scale 4. Differential Ability Scale or Mullen Scales of Early Learning 5. Aberrant Behavior Checklist 6. Caregiver Strain Questionnaire 7. Open Source - Challenging Behavior Checklist 8. Clinical Global Impression scale (Improvement Scale)
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Toileting Programming: Enuresis Treatment to a Randomized Clinical Trial of a Caregiver-Mediated Multidisciplinary Intervention for Encopresis
- ClinicalTrials.gov ID
- NCT07226739
- Acronym / sponsor ID
- STUDY00010223
- Conditions
- Encopresis, ASD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aims to monitor fecal continence after autistic youth complete enuresis treatment and for individuals who continue to experience encopresis after acquiring urine continence, evaluate a caregiver-mediated version of a Multidisciplinary Intervention for Encopresis (CM-MIE) delivered via telehealth to determine efficacy in a randomized clinical trial.
Detailed description
Participants will complete toilet training for enuresis (if needed) and then monitored to determine if encopresis persists. For individuals with resolved enuresis but persisting encopresis, they will be randomized to receive either a treatment for encopresis (delivered via telehealth) or a parent education program. The encopresis intervention involves behavioral components and administration of an over-the-counter suppository as needed. All participants will also meet with a pediatric gastroenterologist to ensure safety of study procedures and to resolve constipation as needed. Outcomes will include caregiver-completed questionnaires, data on bowel movements collected by the caregiver, and an interview between the participant's caregiver and a blinded investigator focused on encopresis, other presenting concerns, and any potential adverse events.
Informed consent will be collected via signature from one legal guardian. The investigators will collect assent from participants when appropriate given age and developmental level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregiver-mediated version of multidisciplinary intervention for encopresis (CM-MIE) Arm | Experimental | Drug: Glycerin Suppository, Behavioral: Behavioral strategies* A Board-Certified Behavior Analyst (BCBA) will meet virtually with caregivers for daily appointments for two weeks (goal of 10 appointments; maximum of 2-hours per appointment). * First appointment, the BCBA will provide support on using telehealth and psychoeducation about encopresis, reinforcement, and suppository use. * Subsequent appointments involve a scheduled sit on the toilet to encourage an independent bowel movement. If a bowel movement occurs, the caregiver is coached to provide the child with a highly preferred item, praise, and allow them to leave the bathroom. If a bowel movement does not occur, the therapist coaches the parent through administration of a glycerin suppository intended to quickly elicit a bowel movement, followed by another scheduled sit on the toilet. * After consistent success with continent BMs following suppository administration, the suppository dose will be reduced to gradually fade out its use. |
| Parent Education (PE) Arm | Active comparator | Behavioral: Behavioral strategies* PE includes an initial appointment with a BCBA who will provide recommendations on promoting bowel movement continence. * First appointment will involve a didactic review of the basics of reinforcement, collecting data to identify when BMs are most likely, and scheduled sits around this time. Caregivers will be instructed to collect data on BMs after this appointment. * The BCBA will then hold daily follow-up appointments (10 appointments total over 2 weeks). At these appointments, the BCBA will review this data and make additional recommendations (e.g., changing the timing of scheduled sits based on when BMs are most likely to occur, altering the reinforcer used for continent voids) to promote success. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 5 to 12
- Diagnosis of an intellectual or developmental delay (excluding individuals with ADHD alone)
- Encopresis (more than 1 incontinent BM a week)
- Required for pre-randomization phase only: Enuresis (> 1 incontinent urination per day when on a consistent toileting sit schedule)
- At least one caregiver who speaks and understands English
Key exclusion criteria (4 listed)
- Unresolved medical condition that would impede toilet training (e.g., interference with sphincter control, short gut syndrome, urinary tract or gastrointestinal infection, unexplained diarrhea, recent intestinal surgery, inflammatory bowel disease)
- Failed intensive toileting treatment in the past 2 yrs with protocols akin to study
- Current serious behavioral or psychiatric disorder that requires another treatment
- Current or planned other intervention (behavioral or medical) for incontinence
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 SuppositoryAlso: MAJOR® GlycerinLiquid glycerin suppositories, pediatric (age 2-5 years: 4 ml/applicator) or adult (6-12 years: 7.5ml/applicator) dose used as indicated based on age will be used in the study. Up to two doses will be delivered a day. The purpose of the glycerin suppository is to rapidly evoke a bowel movement, which allows for a predictable bowel movement to occur while the child is seated on the toilet (a continent bowel movement). | Drug | Caregiver-mediated version of multidisciplinary intervention for encopresis (CM-MIE) Arm |
| Behavioral strategiesThe BCBA will provide recommendations on promoting bowel movement continence. The caregiver will be asked to collect data between visits that will be reviewed by the therapist. | Behavioural | Caregiver-mediated version of multidisciplinary intervention for encopresis (CM-MIE) Arm, Parent Education (PE) Arm |
Primary outcome
Clinical Global Impression Improvement (CGI-I) scale score
Time frame: 5 weeks post-baseline (Endpoint)
The CGI-I is a clinician-rated 7-point scale measuring overall change from baseline. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse), rated by the treatment-blind independent evaluator (IE) with all available information. CGI-I ratings of Much Improved (score of 2) or Very Much Improved (score of 1) will define positive response; all other ratings are defined as nonresponders. Number of positive responses for the Clinical Global Impression scale will be compared between the CM-MIE and the PE group.
2 secondary outcomes
Caregiver Strain Questionnaire-short form (CGSQ-SF) score
Time frame: 5 weeks post-baseline (Endpoint)
Fecal continence based on caregiver-collected data
Time frame: 5 weeks post-baseline (Endpoint)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. The below information will all be shared through NIMH Data Archive (NDA): 1. Diagnostic information 2. Scores from developmental measures (e.g., ADOS or CARS) 3. Vineland Adaptive Behavior Scale 4. Differential Ability Scale or Mullen Scales of Early Learning 5. Aberrant Behavior Checklist 6. Caregiver Strain Questionnaire 7. Open Source - Challenging Behavior Checklist 8. Clinical Global Impression scale (Improvement Scale)
Related trials for Encopresis
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Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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Active, not recruitingPhase 4
Use of the LEVA® Pelvic Health System for Fecal Incontinence
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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.
Mindy Scheithauer, 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 Phase 4 study testing Glycerin Suppository and Behavioral strategies in people with Encopresis and ASD, 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 5 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mindy Scheithauer, PhD (404-785-9322, Mindy.Scheithauer@choa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression Improvement (CGI-I) scale score (time frame: 5 weeks post-baseline (Endpoint)). 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 18 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.