EncopresisPhase 3NCT03197922
Treatment of Encopresis in Children With Autism Spectrum Disorders
A Phase 3 study testing MIE Treatment, Glycerin Suppository and Treatment as Usual (TAU) in people with Encopresis and Autism Spectrum Disorder, run by Emory University at 1 site in United States.
Trial summary
This study is comparing a multidisciplinary intervention for encopresis (MIE), consisting of both medical and behavioral components to treatment as usual control (TAU). Participants are first screened by a pediatric gastroenterologist and assessed and treated for any constipation or other potential medical… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Encopresis, Autism Spectrum Disorder
- What is being tested?
- MIE Treatment, Glycerin Suppository and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2017to 17 Nov 2022
- Phase
- Phase 3
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females from 5 years of age to 12 years 11 months of age.
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of Autism Spectrum Disorder as established by clinical assessment, corroborated by the Autism Diagnostic Observational Schedule, Autism Diagnostic Interview-Revised and/or Childhood Autism Rating Scale-Second Edition.
- Fewer than 60% of days are continent days or more than 1 day out of 7 is an incontinent day over the previous 7 days (a continent day is defined as a day with at least one continent bowel movement. An incontinent day is a day with an incontinent bowel movement regardless of whether a continent bowel movement also occurs).
- Medication free or on stable medication (no changes in past 6 weeks and no planned changes for the next 6 months).
- Urine continent - Over half of the voids are continent when the child is with the parent and when the child is on a typical toileting routine.
Who cannot join
- Presence of a known medical condition in the child (based on medical history or physical examination) that would interfere with child's ability to control his/her anus. These include: history of any anal surgery, spinal dysraphism (e.g., spina bifida), other neurologic disorder affecting anal function, and prolonged/recurrent gastrointestinal infectious disease (e.g. Clostridium difficile colitis). In addition, the following may constitute exclusions following evaluation by a physician: inflammatory bowel disease, short gut syndrome, chronic diarrhea, or history of intestinal/abdominal surgery.
- Presence of a current serious behavioral problem or psychiatric condition that would require another treatment (e.g., psychotic disorder, major depression, moderate or greater aggression, severe disruptive behavior), based on information collected at screening and the Behavior Problems Inventory-01 (BPI-01).
- Currently receiving and caregiver refusal to discontinue ongoing behavioral or alternative medical intervention for encopresis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multidisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
This study is comparing a multidisciplinary intervention for encopresis (MIE), consisting of both medical and behavioral components to treatment as usual control (TAU). Participants are first screened by a pediatric gastroenterologist and assessed and treated for any constipation or other potential medical complications. Following this, caregivers collect data on bowel movements and continence during a home baseline lasting no less than 14 days and no more than 21 days. Participants randomly assigned to treatment as usual or the treatment group, and begin attending daily appointments in clinic for 2 weeks. At appointments, the behavior team implements structured sits on the toilet to promote independent bowel movements (BMs). If an independent BM does not occur, the study team will administer a suppository to promote rapid release of the bowels and prompt the child to remain on the toilet following administration. In doing so, continent bowel movements are predictably evoked while the child is on the toilet, allowing for reinforcement with praise and preferred toys/activities. Eventually, suppositories are gradually decreased until the child is having BMs independently. Caregivers are trained to continue implementing the intervention following the clinic-based portion.
The purpose of the current study is to evaluate MIE using a large randomized clinical trial (RCT), addressing the Department of Defense Autism Research Program, Area of Interest of Therapies to Alleviate Conditions Co-Occurring with autism spectrum disorder (ASD). The researchers will recruit 112 children diagnosed with ASD, randomizing them to two weeks of MIE, or treatment as usual (TAU) consisting of behavioral consultation and medical intervention. This study will evaluate MIE compared to TAU and determine the optimal treatment length.
Read the detailed description
Toilet training one's child is a nearly universal challenge for parents, but is a particularly distressing ordeal for parents of individuals with autism spectrum disorder (ASD). Whereas typically developing children generally stop having daytime toileting accidents (i.e., they achieve continence) by 2-4 years of age, most individuals with ASD are either delayed in their acquisition of toileting skills, or never achieve continence. Furthermore, toileting concerns are a significant contributor to the increased stress experienced by caregivers of those with ASD. Besides dramatically increasing their burden of care, not being fully toilet trained negatively impacts the individual with ASD's hygiene, self-confidence, physical comfort, and independence while also causing social stigma. Incontinence can also have serious collateral consequences, such as limiting exposure to important life experiences. Furthermore, without effective treatment these problems generally persist into adulthood.
One reason why strictly behavioral treatments of encopresis have shown only limited success may be due to the fact that it often has a medical etiology. Encopresis is when underwear are soiled by stool in children over the age of toilet training and long-standing constipation is the cause of encopresis in the majority of children who exhibit it. Children with ASD are more likely to have constipation than typically developing children. Constipation causes encopresis by creating a cycle of withholding bowel movements (withholding is the voluntary contraction of the external sphincter to avoid a bowel movement): constipation causes painful bowel movements, which triggers further withholding behavior, exacerbating constipation. Over time the colon adapts by dilating, which leads to larger fecal masses in the rectum. Thus, the passage of larger and harder (i.e., painful) stools further increases an individual's withholding behavior. Over time, the rectum and colon become so dilated that the individual loses sensation. With no urge to defecate, an individual is even more likely to have stool accumulate in the rectum and is also unable to control bowel movements. Looser stool may leak around hard stool leading to an unintended leakage and sometimes large evacuation of stool occurs without the individual realizing it.
Although purely medical approaches can successfully treat constipation in individuals with ASD, they have not shown long term success with encopresis. That is, medical approaches can treat a single episode of constipation, but without acquiring toileting skills, the individual is likely to become constipated again, repeating the cycle. Conversely, purely behavioral strategies have not been shown to be effective at treating encopresis in individuals with ASD, even when they are not experiencing constipation. One reason for this lack of success may have to do with the fact that it is often difficult to predict the timing of a bowel movement so that caregivers can ensure the individual is sitting on the toilet when one takes place and then reinforce continence. Thus, a multidisciplinary approach incorporating both medical and behavioral approaches is necessary in the treatment of encopresis in individuals with ASD.
This is an 8-week, randomized clinical trial of 112 children, ages 5 to 12 years, 11 months with ASD and encopresis. Participants will be randomized to receive either two weeks of MIE or one week of TAU. The study initially had a third study arm of one week of MIE treatment, which was discontinued in October of 2019.
- Conditions
- Encopresis, Autism Spectrum Disorder
- Being tested
- MIE Treatment, Glycerin Suppository, Treatment as Usual (TAU)
- Keywords
- Constipation
- Medical subject headings
- Encopresis, Autism Spectrum Disorder, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIE TreatmentBehavioural
Also called Multidisciplinary Intervention for Encopresis
Appointments consist of a series of sitting routines (i.e., "sits"). Each sit consists of 10 min on the toilet, followed by 1 min of standing, then repeating the 10 min on the toilet 1 min off, for up to 32 cumulative minutes of sitting. The first sit occurs prior to the administration of any medication providing an opportunity for an independent continent bowel movement.
Glycerin SuppositoryDrug
If no continent bowel movement occurs with the first sit, trained staff administer a dose of a liquid glycerin suppository, immediately followed by another sit to ensure any resulting bowel movement is continent. Glycerin suppositories are replaced by bisacodyl if 2 days pass without a continent bowel movement using the liquid glycerin suppository. Behavioral intervention consists of potent positive reinforcers when a continent bowel movement occurs. As independent continent bowel movements begin to occur, the need for the medical regimen diminishes, and is gradually faded out entirely.
Treatment as Usual (TAU)Combination product
Participants randomized to the Treatment as Usual (TAU) group will continue to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group will receive a 2-hour individual appointment in clinic with a doctoral level clinician with extensive experience in behavioral treatments for encopresis. During the appointment, the clinician will review strategies to increase continence by providing parent education on the following topics: how to collect and evaluate data on their child's bowel movements, how to establish and use a sit schedule, identifying behaviors that are precursors to bowel movements and how to use them to increase the probability of a bowel movement being continent, consequences for incontinence, and reinforcement for continence.
| Study group | Role | What they receive |
|---|---|---|
| MIE Treatment for Two Weeks | Experimental | Participants in this arm will receive the Multidisciplinary Intervention for Encopresis (MIE) for two weeks. MIE consists of daily clinic appointments, each of which lasts until a continent bowel movement occurs or 3 hours elapse. These participants will discontinue the use of medication previously prescribed for the treatment of constipation, other than the suppositories used in the MIE treatment. During MIE, medical professionals resolve any constipation and oversee a regimen of over the counter medications that increase the predictability of a bowel movement. Receives: Behavioral: MIE Treatment; Drug: Glycerin Suppository |
| Treatment as Usual (TAU) | Active comparator | Participants randomized to the Treatment as Usual (TAU) group will continue to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. Additionally, participants in the TAU group will receive a 2-hour long individual appointment with a doctoral level clinician with extensive experience in behavioral treatments for encopresis. Receives: Combination Product: Treatment as Usual (TAU) |
| MIE Treatment for One Week | Experimental | Participants in this arm will receive the Multidisciplinary Intervention for Encopresis (MIE) for one week. This study arm was discontinued in October 2019. Receives: Behavioral: MIE Treatment; Drug: Glycerin Suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Continent Bowel Movements
The percentage to continent bowel movements, based on parent report during the prior 7 day period, are reported for Baseline and the end of treatment at Week 8.
Measured: Baseline, Week 8
Secondary outcomes (5)
Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) Score
The Clinical Global Impression Scale - Improvement (CGI-I) is a single item asking clinicians to indicate the degree of improvement following treatment on a 7-point scale. Responses are 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. This study is interested in the proportion of children who are rated by the Independent Evaluator as "Much Improved" or "Very Much Improved" on the CGI-I at Week 8. Responding to treatment is defined as a score of 1 or 2, while scores of 3 to 7 are considered as not responding to treatment. Response to treatment is analyzed through imputation, consistent with an intent to treat approach, where participants who withdrew from the study or were lost to follow-up prior to the Week 8 assessment are considered to be non-responders.
Measured: Week 8
Parenting Stress Index Short Form Total Score
The Parenting Stress Index Short Form (PSI-SF) is a 36-item questionnaire assessing parental stress. It has three subscales of Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Each subscale has 12 items where responses are given on a 5-point scale where 1 = strongly disagree and 5 = strongly agree. Scores for subscales range from 12 to 60 and the total score ranges from 36 to 180. Higher scores indicate greater parental stress.
Measured: Baseline, Week 8
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Objective Strain Subscale Score
The Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) assesses parental stress and strain in the prior month in caregivers who are caring for a child with behavioral disorders. The CGSQ-SF includes 7 items where responses are given on a 5-point scale where "not at all" is scored as 0 and "very much" is scored as 4. The CGSQ-SF7 has two subscales: Objective Strain with four items, and Subjective Internalized Strain with three items. The total score for the Objective Strain subscale ranges from 0 to 16 and higher scores indicate greater parental strain.
Measured: Baseline, Week 8
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Subjective Internalized Strain Subscale Score
The Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) assesses parental stress and strain in the prior month in caregivers who are caring for a child with behavioral disorders. The CGSQ-SF includes 7 items where responses are given on a 5-point scale where "not at all" is scored as 0 and "very much" is scored as 4. The CGSQ-SF7 has two subscales: Objective Strain with four items, and Subjective Internalized Strain with three items. The total score for the Subjective Internalized Strain subscale ranges from 0 to 12 and higher scores indicate greater parental strain.
Measured: Baseline, Week 8
Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) Total Score
The Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) assesses parental stress and strain in the prior month in caregivers who are caring for a child with behavioral disorders. The CGSQ-SF includes 7 items where responses are given on a 5-point scale where "not at all" is scored as 0 and "very much" is scored as 4. The CGSQ-SF7 has two subscales: Objective Strain with four items, and Subjective Internalized Strain with three items. A total score is obtained by adding the scores for each subscale. Total scores range from 0 to 28 where higher scores indicate greater caregiver strain.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start25 Oct 2017
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 56 participants will be assigned to 2 weeks of the Multidisciplinary Intervention for Encopresis (MIE) treatment, 56 will be assigned to treatment as usual (TAU) as a control group. Twenty-six participants were assigned to the study arm with one week of MIE, which has been discontinued.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Nathan A. Call, Emory University
- Investigators
- Nathan Call, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197922
- Sponsor's protocol ID
- IRB00095849
- Status last verified
- Jan 2024
- First submitted
- 21 Jun 2017
- Last updated
- 31 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT03197922
- Acronym / sponsor ID
- IRB00095849
- Conditions
- Encopresis, Autism Spectrum Disorder
- Keywords
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Posted 31 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is comparing a multidisciplinary intervention for encopresis (MIE), consisting of both medical and behavioral components to treatment as usual control (TAU). Participants are first screened by a pediatric gastroenterologist and assessed and treated for any constipation or other potential medical complications. Following this, caregivers collect data on bowel movements and continence during a home baseline lasting no less than 14 days and no more than 21 days. Participants randomly assigned to treatment as usual or the treatment group, and begin attending daily appointments in clinic for 2 weeks. At appointments, the behavior team implements structured sits on the toilet to promote independent bowel movements (BMs). If an independent BM does not occur, the study team will administer a suppository to promote rapid release of the bowels and prompt the child to remain on the toilet following administration. In doing so, continent bowel movements are predictably evoked while the child is on the toilet, allowing for reinforcement with praise and preferred toys/activities. Eventually, suppositories are gradually decreased until the child is having BMs independently. Caregivers are trained to continue implementing the intervention following the clinic-based portion.
The purpose of the current study is to evaluate MIE using a large randomized clinical trial (RCT), addressing the Department of Defense Autism Research Program, Area of Interest of Therapies to Alleviate Conditions Co-Occurring with autism spectrum disorder (ASD). The researchers will recruit 112 children diagnosed with ASD, randomizing them to two weeks of MIE, or treatment as usual (TAU) consisting of behavioral consultation and medical intervention. This study will evaluate MIE compared to TAU and determine the optimal treatment length.
Detailed description
Toilet training one's child is a nearly universal challenge for parents, but is a particularly distressing ordeal for parents of individuals with autism spectrum disorder (ASD). Whereas typically developing children generally stop having daytime toileting accidents (i.e., they achieve continence) by 2-4 years of age, most individuals with ASD are either delayed in their acquisition of toileting skills, or never achieve continence. Furthermore, toileting concerns are a significant contributor to the increased stress experienced by caregivers of those with ASD. Besides dramatically increasing their burden of care, not being fully toilet trained negatively impacts the individual with ASD's hygiene, self-confidence, physical comfort, and independence while also causing social stigma. Incontinence can also have serious collateral consequences, such as limiting exposure to important life experiences. Furthermore, without effective treatment these problems generally persist into adulthood.
One reason why strictly behavioral treatments of encopresis have shown only limited success may be due to the fact that it often has a medical etiology. Encopresis is when underwear are soiled by stool in children over the age of toilet training and long-standing constipation is the cause of encopresis in the majority of children who exhibit it. Children with ASD are more likely to have constipation than typically developing children. Constipation causes encopresis by creating a cycle of withholding bowel movements (withholding is the voluntary contraction of the external sphincter to avoid a bowel movement): constipation causes painful bowel movements, which triggers further withholding behavior, exacerbating constipation. Over time the colon adapts by dilating, which leads to larger fecal masses in the rectum. Thus, the passage of larger and harder (i.e., painful) stools further increases an individual's withholding behavior. Over time, the rectum and colon become so dilated that the individual loses sensation. With no urge to defecate, an individual is even more likely to have stool accumulate in the rectum and is also unable to control bowel movements. Looser stool may leak around hard stool leading to an unintended leakage and sometimes large evacuation of stool occurs without the individual realizing it.
Although purely medical approaches can successfully treat constipation in individuals with ASD, they have not shown long term success with encopresis. That is, medical approaches can treat a single episode of constipation, but without acquiring toileting skills, the individual is likely to become constipated again, repeating the cycle. Conversely, purely behavioral strategies have not been shown to be effective at treating encopresis in individuals with ASD, even when they are not experiencing constipation. One reason for this lack of success may have to do with the fact that it is often difficult to predict the timing of a bowel movement so that caregivers can ensure the individual is sitting on the toilet when one takes place and then reinforce continence. Thus, a multidisciplinary approach incorporating both medical and behavioral approaches is necessary in the treatment of encopresis in individuals with ASD.
This is an 8-week, randomized clinical trial of 112 children, ages 5 to 12 years, 11 months with ASD and encopresis. Participants will be randomized to receive either two weeks of MIE or one week of TAU. The study initially had a third study arm of one week of MIE treatment, which was discontinued in October of 2019.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 56 participants will be assigned to 2 weeks of the Multidisciplinary Intervention for Encopresis (MIE) treatment, 56 will be assigned to treatment as usual (TAU) as a control group. Twenty-six participants were assigned to the study arm with one week of MIE, which has been discontinued.
| Arm | Type | Receives |
|---|---|---|
| MIE Treatment for Two Weeks | Experimental | Behavioral: MIE Treatment, Drug: Glycerin SuppositoryParticipants in this arm will receive the Multidisciplinary Intervention for Encopresis (MIE) for two weeks. MIE consists of daily clinic appointments, each of which lasts until a continent bowel movement occurs or 3 hours elapse. These participants will discontinue the use of medication previously prescribed for the treatment of constipation, other than the suppositories used in the MIE treatment. During MIE, medical professionals resolve any constipation and oversee a regimen of over the counter medications that increase the predictability of a bowel movement. |
| Treatment as Usual (TAU) | Active comparator | Combination Product: Treatment as Usual (TAU)Participants randomized to the Treatment as Usual (TAU) group will continue to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. Additionally, participants in the TAU group will receive a 2-hour long individual appointment with a doctoral level clinician with extensive experience in behavioral treatments for encopresis. |
| MIE Treatment for One Week | Experimental | Behavioral: MIE Treatment, Drug: Glycerin SuppositoryParticipants in this arm will receive the Multidisciplinary Intervention for Encopresis (MIE) for one week. This study arm was discontinued in October 2019. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males and females from 5 years of age to 12 years 11 months of age.
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of Autism Spectrum Disorder as established by clinical assessment, corroborated by the Autism Diagnostic Observational Schedule, Autism Diagnostic Interview-Revised and/or Childhood Autism Rating Scale-Second Edition.
- Fewer than 60% of days are continent days or more than 1 day out of 7 is an incontinent day over the previous 7 days (a continent day is defined as a day with at least one continent bowel movement. An incontinent day is a day with an incontinent bowel movement regardless of whether a continent bowel movement also occurs).
- Medication free or on stable medication (no changes in past 6 weeks and no planned changes for the next 6 months).
- Urine continent - Over half of the voids are continent when the child is with the parent and when the child is on a typical toileting routine.
Key exclusion criteria (3 listed)
- Presence of a known medical condition in the child (based on medical history or physical examination) that would interfere with child's ability to control his/her anus. These include: history of any anal surgery, spinal dysraphism (e.g., spina bifida), other neurologic disorder affecting anal function, and prolonged/recurrent gastrointestinal infectious disease (e.g. Clostridium difficile colitis). In addition, the following may constitute exclusions following evaluation by a physician: inflammatory bowel disease, short gut syndrome, chronic diarrhea, or history of intestinal/abdominal surgery.
- Presence of a current serious behavioral problem or psychiatric condition that would require another treatment (e.g., psychotic disorder, major depression, moderate or greater aggression, severe disruptive behavior), based on information collected at screening and the Behavior Problems Inventory-01 (BPI-01).
- Currently receiving and caregiver refusal to discontinue ongoing behavioral or alternative medical intervention for encopresis.
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 |
|---|---|---|
| MIE TreatmentAlso: Multidisciplinary Intervention for EncopresisAppointments consist of a series of sitting routines (i.e., "sits"). Each sit consists of 10 min on the toilet, followed by 1 min of standing, then repeating the 10 min on the toilet 1 min off, for up to 32 cumulative minutes of sitting. The first sit occurs prior to the administration of any medication providing an opportunity for an independent continent bowel movement. | Behavioural | MIE Treatment for One Week, MIE Treatment for Two Weeks |
| Glycerin SuppositoryIf no continent bowel movement occurs with the first sit, trained staff administer a dose of a liquid glycerin suppository, immediately followed by another sit to ensure any resulting bowel movement is continent. Glycerin suppositories are replaced by bisacodyl if 2 days pass without a continent bowel movement using the liquid glycerin suppository. Behavioral intervention consists of potent positive reinforcers when a continent bowel movement occurs. As independent continent bowel movements begin to occur, the need for the medical regimen diminishes, and is gradually faded out entirely. | Drug | MIE Treatment for One Week, MIE Treatment for Two Weeks |
| Treatment as Usual (TAU)Participants randomized to the Treatment as Usual (TAU) group will continue to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group will receive a 2-hour individual appointment in clinic with a doctoral level clinician with extensive experience in behavioral treatments for encopresis. During the appointment, the clinician will review strategies to increase continence by providing parent education on the following topics: how to collect and evaluate data on their child's bowel movements, how to establish and use a sit schedule, identifying behaviors that are precursors to bowel movements and how to use them to increase the probability of a bowel movement being continent, consequences for incontinence, and reinforcement for continence. | Combination product | Treatment as Usual (TAU) |
Primary outcome
Percentage of Continent Bowel Movements
Time frame: Baseline, Week 8
The percentage to continent bowel movements, based on parent report during the prior 7 day period, are reported for Baseline and the end of treatment at Week 8.
5 secondary outcomes
Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) Score
Time frame: Week 8
Parenting Stress Index Short Form Total Score
Time frame: Baseline, Week 8
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Objective Strain Subscale Score
Time frame: Baseline, Week 8
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Subjective Internalized Strain Subscale Score
Time frame: Baseline, Week 8
Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) Total Score
Time frame: Baseline, Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. 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 Phase 3 study testing MIE Treatment, Glycerin Suppository and Treatment as Usual (TAU) in people with Encopresis and Autism Spectrum 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 5 inclusion and 3 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 31 Jan 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2024). 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?
Percentage of Continent Bowel Movements (time frame: Baseline, Week 8). 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 31 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.