<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03821532</url>
  </required_header>
  <id_info>
    <org_study_id>947325</org_study_id>
    <nct_id>NCT03821532</nct_id>
  </id_info>
  <brief_title>Adherence/Outcomes After Use of Constipation Action Plan</brief_title>
  <official_title>Evaluation of Adherence and Outcomes in Children With Functional Constipation After Implementing a Constipation Action Plan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nemours Children's Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nemours Children's Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adherence to recommendations for treatment of chronic constipation in pediatric population is&#xD;
      often poor. This study is attempting to improve adherence, and outcomes, by implementing a&#xD;
      trial of a constipation action plan plus standard of care, compared to standard of care&#xD;
      alone, in an outpatient pediatric population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Functional Constipation is a common childhood problem. The goal of this study is to evaluate&#xD;
      if a constipation action plan had any impact on improved adherence in management. Children&#xD;
      are eligible to participate in the study if they are otherwise healthy children whose primary&#xD;
      language is English with no conditions that would predispose them to develop constipation,&#xD;
      between the ages of 3 and 8 years of age and if they meet the ROME IV criteria for functional&#xD;
      constipation. The primary objective is to assess compliance in pediatric patients with&#xD;
      functional constipation that have been provided a constipation action plan plus educational&#xD;
      information. The secondary objectives are to assess improvement of constipation symptoms in&#xD;
      pediatric patients with functional constipation that have been provided a constipation action&#xD;
      plan and educational information and to assess the perceived effectiveness of the&#xD;
      constipation action plan from the viewpoint of the family. The proposed study hypothesizes&#xD;
      that patients diagnosed with functional constipation will have improved adherence to&#xD;
      medication treatment plan, to fiber intake, and to toilet sit time and have improved&#xD;
      constipation symptoms overall when provided with both a constipation action plan and&#xD;
      educational information regarding dietary changes, toilet sit time, and medications as&#xD;
      compared to education information alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2016</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Control group (standard of care) compared to Intervention group (standard of care plus constipation action plan)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Packet of information containing Standard of Care education materials and {Action Plan or No Action Plan} are prepared prior to enrollment; all participants get unlabeled packet without prior knowledge of participant or investigator or care provider.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance Questionnaire</measure>
    <time_frame>At screening</time_frame>
    <description>Evaluate compliance using the constipation/adherence questionnaire. The questionnaire has 3 questions addressing the total number of days missed per week taking the prescribed medications, toilet sit times and dietary intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance Questionnaire</measure>
    <time_frame>1 Month</time_frame>
    <description>Compliance will be evaluated by reviewing the sticker reward chart at the 3 month visit and calculating the number of days the child missed medication dose, did not sit on the toilet as instructed and how many days were missed of adequate fiber intake. Further evaluate compliance using the constipation/adherence questionnaire. The questionnaire has 3 questions addressing the total number of days missed per week taking the prescribed medications, toilet sit times and dietary intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance Questionnaire</measure>
    <time_frame>3 Month</time_frame>
    <description>Compliance will be evaluated by reviewing the sticker reward chart at the 3 month visit and calculating the number of days the child missed medication dose, did not sit on the toilet as instructed and how many days were missed of adequate fiber intake. Further evaluate compliance using the constipation/adherence questionnaire. The questionnaire has 3 questions addressing the total number of days missed per week taking the prescribed medications, toilet sit times and dietary intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance Reward Chart</measure>
    <time_frame>3 Month</time_frame>
    <description>Compliance will be evaluated by reviewing the sticker reward chart at the 3 month visit and calculating the number of days the child missed medication dose, did not sit on the toilet as instructed and how many days were missed of adequate fiber intake.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptoms</measure>
    <time_frame>At screening</time_frame>
    <description>Number of participants with positive constipation symptoms using ROME IV Criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms</measure>
    <time_frame>1 Month</time_frame>
    <description>Number of participants with positive constipation symptoms using ROME IV Criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms</measure>
    <time_frame>3 Month</time_frame>
    <description>Number of participants with positive constipation symptoms using ROME IV Criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived effectiveness</measure>
    <time_frame>1 month telephone encounter</time_frame>
    <description>Anonymous survey addresses questions regarding the number of days the child was in each zone of the constipation action plan and whether or not the plan helped the family better manage the child's symptoms, decreased calls to the physician and whether or not it was easy to use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived effectiveness</measure>
    <time_frame>3 month follow up visit</time_frame>
    <description>Anonymous survey addresses questions regarding the number of days the child was in each zone of the constipation action plan and whether or not the plan helped the family better manage the child's symptoms, decreased calls to the physician and whether or not it was easy to use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Literacy</measure>
    <time_frame>0 months</time_frame>
    <description>Assess literacy level for caregivers by administering the Short-Form Rapid Assessment of Adult Literacy in Medicine. Final score of 0, 1-3, 4-6, or 7 determines grade reading level (3rd grade or less, 4th to 6th, 7th to 8th, 9th grade and higher). There is no better or worse outcome, just stratification of literacy (medical) is determined.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Constipation - Functional</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Each family will receive a randomized packet containing educational information, rewards charts and an adult literacy test. The treatment plan will be determined based on recommendations from the clinical guidelines for the Evaluation and Treatment of Functional Constipation Infants and Children as published by the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. At the first visit, the parent(s) will complete an adult literacy test and an initial paper questionnaire regarding symptoms, adherence to the treatment plan and demographics. At 1 month, the primary investigator will call each family and administer a phone survey regarding symptoms and adherence to the treatment plan in the past month. At 3 months, the families will return for a follow up visit with their 3 month reward charts and complete a final paper survey regarding the child's symptoms and adherence to the treatment plan.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each family will receive a randomized packet containing educational information, rewards charts, an adult literacy test and a constipation action plan tool. The treatment plan will be determined based on recommendations from the clinical guidelines for the Evaluation and Treatment of Functional Constipation Infants and Children as published by the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. At the first visit, the parent(s) will complete an adult literacy test and an initial paper questionnaire regarding symptoms, adherence to the treatment plan and demographics. At 1 month, the primary investigator will call each family and administer a phone survey regarding symptoms and adherence to the treatment plan in the past month. At 3 months, the families will return for a follow up visit with their 3 month reward charts and complete a final paper survey regarding the child's symptoms, adherence to the treatment plan, and action plan utility.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Constipation Action Plan</intervention_name>
    <description>Action plan, adapted from Autism Speaks Network, demonstrating Red, Yellow, and Green levels of symptoms with corresponding steps for treatment or action by parent/guardian, tailored by care provider to the child's condition.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  History of functional constipation&#xD;
&#xD;
          -  English as primary language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of medical conditions pre-disposing to constipation&#xD;
&#xD;
          -  English as a second language&#xD;
&#xD;
          -  Chronic gastrointestinal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Di Guglielmo, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nemours</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alfred I. duPont Hospital for Children</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Palsson OS, Whitehead WE, van Tilburg MA, Chang L, Chey W, Crowell MD, Keefer L, Lembo AJ, Parkman HP, Rao SS, Sperber A, Spiegel B, Tack J, Vanner S, Walker LS, Whorwell P, Yang Y. Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians. Gastroenterology. 2016 Feb 13:S0016-5085(16)00180-3. doi: 10.1053/j.gastro.2016.02.014. Online ahead of print.</citation>
    <PMID>27144634</PMID>
  </reference>
  <reference>
    <citation>van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol. 2006 Oct;101(10):2401-9. doi: 10.1111/j.1572-0241.2006.00771.x.</citation>
    <PMID>17032205</PMID>
  </reference>
  <reference>
    <citation>Steiner SA, Torres MR, Penna FJ, Gazzinelli BF, Corradi CG, Costa AS, Ribeiro IG, de Andrade EG, do Carmo Barros de Melo M. Chronic functional constipation in children: adherence and factors associated with drug treatment. J Pediatr Gastroenterol Nutr. 2014 May;58(5):598-602. doi: 10.1097/MPG.0000000000000255.</citation>
    <PMID>24345842</PMID>
  </reference>
  <reference>
    <citation>Graves MM, Roberts MC, Rapoff M, Boyer A. The efficacy of adherence interventions for chronically ill children: a meta-analytic review. J Pediatr Psychol. 2010 May;35(4):368-82. doi: 10.1093/jpepsy/jsp072. Epub 2009 Aug 26.</citation>
    <PMID>19710248</PMID>
  </reference>
  <reference>
    <citation>Luersen K, Davis SA, Kaplan SG, Abel TD, Winchester WW, Feldman SR. Sticker charts: a method for improving adherence to treatment of chronic diseases in children. Pediatr Dermatol. 2012 Jul-Aug;29(4):403-8. doi: 10.1111/j.1525-1470.2012.01741.x. Epub 2012 Apr 4.</citation>
    <PMID>22471987</PMID>
  </reference>
  <reference>
    <citation>Ismail N, Ratchford I, Proudfoot C, Gibbs J. Impact of a nurse-led clinic for chronic constipation in children. J Child Health Care. 2011 Sep;15(3):221-9. doi: 10.1177/1367493511406568. Epub 2011 Aug 9.</citation>
    <PMID>21828166</PMID>
  </reference>
  <reference>
    <citation>Arozullah AM, Yarnold PR, Bennett CL, Soltysik RC, Wolf MS, Ferreira RM, Lee SY, Costello S, Shakir A, Denwood C, Bryant FB, Davis T. Development and validation of a short-form, rapid estimate of adult literacy in medicine. Med Care. 2007 Nov;45(11):1026-33. doi: 10.1097/MLR.0b013e3180616c1b.</citation>
    <PMID>18049342</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nemours Children's Clinic</investigator_affiliation>
    <investigator_full_name>Matthew Di Guglielmo</investigator_full_name>
    <investigator_title>Clinical Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Action Plan</keyword>
  <keyword>Adherence</keyword>
  <keyword>Pediatrics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 18, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03821532/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03821532
org study id: 947325
nct id: NCT03821532
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adherence to recommendations for treatment of chronic constipation in pediatric population is
      often poor. This study is attempting to improve adherence, and outcomes, by implementing a
      trial of a constipation action plan plus standard of care, compared to standard of care
      alone, in an outpatient pediatric population.
Functional Constipation is a common childhood problem. The goal of this study is to evaluate
      if a constipation action plan had any impact on improved adherence in management. Children
      are eligible to participate in the study if they are otherwise healthy children whose primary
      language is English with no conditions that would predispose them to develop constipation,
      between the ages of 3 and 8 years of age and if they meet the ROME IV criteria for functional
      constipation. The primary objective is to assess compliance in pediatric patients with
      functional constipation that have been provided a constipation action plan plus educational
      information. The secondary objectives are to assess improvement of constipation symptoms in
      pediatric patients with functional constipation that have been provided a constipation action
      plan and educational information and to assess the perceived effectiveness of the
      constipation action plan from the viewpoint of the family. The proposed study hypothesizes
      that patients diagnosed with functional constipation will have improved adherence to
      medication treatment plan, to fiber intake, and to toilet sit time and have improved
      constipation symptoms overall when provided with both a constipation action plan and
      educational information regarding dietary changes, toilet sit time, and medications as
      compared to education information alone.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Control group (standard of care) compared to Intervention group (standard of care plus constipation action plan)
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Packet of information containing Standard of Care education materials and {Action Plan or No Action Plan} are prepared prior to enrollment; all participants get unlabeled packet without prior knowledge of participant or investigator or care provider.
measure: Compliance Questionnaire
time frame: At screening
description: Evaluate compliance using the constipation/adherence questionnaire. The questionnaire has 3 questions addressing the total number of days missed per week taking the prescribed medications, toilet sit times and dietary intake
measure: Compliance Questionnaire
time frame: 1 Month
description: Compliance will be evaluated by reviewing the sticker reward chart at the 3 month visit and calculating the number of days the child missed medication dose, did not sit on the toilet as instructed and how many days were missed of adequate fiber intake. Further evaluate compliance using the constipation/adherence questionnaire. The questionnaire has 3 questions addressing the total number of days missed per week taking the prescribed medications, toilet sit times and dietary intake
measure: Compliance Questionnaire
time frame: 3 Month
description: Compliance will be evaluated by reviewing the sticker reward chart at the 3 month visit and calculating the number of days the child missed medication dose, did not sit on the toilet as instructed and how many days were missed of adequate fiber intake. Further evaluate compliance using the constipation/adherence questionnaire. The questionnaire has 3 questions addressing the total number of days missed per week taking the prescribed medications, toilet sit times and dietary intake
measure: Compliance Reward Chart
time frame: 3 Month
description: Compliance will be evaluated by reviewing the sticker reward chart at the 3 month visit and calculating the number of days the child missed medication dose, did not sit on the toilet as instructed and how many days were missed of adequate fiber intake.
measure: Symptoms
time frame: At screening
description: Number of participants with positive constipation symptoms using ROME IV Criteria
measure: Symptoms
time frame: 1 Month
description: Number of participants with positive constipation symptoms using ROME IV Criteria
measure: Symptoms
time frame: 3 Month
description: Number of participants with positive constipation symptoms using ROME IV Criteria
measure: Perceived effectiveness
time frame: 1 month telephone encounter
description: Anonymous survey addresses questions regarding the number of days the child was in each zone of the constipation action plan and whether or not the plan helped the family better manage the child's symptoms, decreased calls to the physician and whether or not it was easy to use.
measure: Perceived effectiveness
time frame: 3 month follow up visit
description: Anonymous survey addresses questions regarding the number of days the child was in each zone of the constipation action plan and whether or not the plan helped the family better manage the child's symptoms, decreased calls to the physician and whether or not it was easy to use.
measure: Caregiver Literacy
time frame: 0 months
description: Assess literacy level for caregivers by administering the Short-Form Rapid Assessment of Adult Literacy in Medicine. Final score of 0, 1-3, 4-6, or 7 determines grade reading level (3rd grade or less, 4th to 6th, 7th to 8th, 9th grade and higher). There is no better or worse outcome, just stratification of literacy (medical) is determined.
arm group label: Control group
arm group type: No Intervention
description: Each family will receive a randomized packet containing educational information, rewards charts and an adult literacy test. The treatment plan will be determined based on recommendations from the clinical guidelines for the Evaluation and Treatment of Functional Constipation Infants and Children as published by the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. At the first visit, the parent(s) will complete an adult literacy test and an initial paper questionnaire regarding symptoms, adherence to the treatment plan and demographics. At 1 month, the primary investigator will call each family and administer a phone survey regarding symptoms and adherence to the treatment plan in the past month. At 3 months, the families will return for a follow up visit with their 3 month reward charts and complete a final paper survey regarding the child's symptoms and adherence to the treatment plan.
arm group label: Experimental group
arm group type: Experimental
description: Each family will receive a randomized packet containing educational information, rewards charts, an adult literacy test and a constipation action plan tool. The treatment plan will be determined based on recommendations from the clinical guidelines for the Evaluation and Treatment of Functional Constipation Infants and Children as published by the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. At the first visit, the parent(s) will complete an adult literacy test and an initial paper questionnaire regarding symptoms, adherence to the treatment plan and demographics. At 1 month, the primary investigator will call each family and administer a phone survey regarding symptoms and adherence to the treatment plan in the past month. At 3 months, the families will return for a follow up visit with their 3 month reward charts and complete a final paper survey regarding the child's symptoms, adherence to the treatment plan, and action plan utility.
intervention type: Other
intervention name: Constipation Action Plan
description: Action plan, adapted from Autism Speaks Network, demonstrating Red, Yellow, and Green levels of symptoms with corresponding steps for treatment or action by parent/guardian, tailored by care provider to the child's condition.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew Di Guglielmo, MD PhD
role: Principal Investigator
affiliation: Nemours
facility: 
country: United States
citation: Palsson OS, Whitehead WE, van Tilburg MA, Chang L, Chey W, Crowell MD, Keefer L, Lembo AJ, Parkman HP, Rao SS, Sperber A, Spiegel B, Tack J, Vanner S, Walker LS, Whorwell P, Yang Y. Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians. Gastroenterology. 2016 Feb 13:S0016-5085(16)00180-3. doi: 10.1053/j.gastro.2016.02.014. Online ahead of print.
PMID: 27144634
citation: van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol. 2006 Oct;101(10):2401-9. doi: 10.1111/j.1572-0241.2006.00771.x.
PMID: 17032205
citation: Steiner SA, Torres MR, Penna FJ, Gazzinelli BF, Corradi CG, Costa AS, Ribeiro IG, de Andrade EG, do Carmo Barros de Melo M. Chronic functional constipation in children: adherence and factors associated with drug treatment. J Pediatr Gastroenterol Nutr. 2014 May;58(5):598-602. doi: 10.1097/MPG.0000000000000255.
PMID: 24345842
citation: Graves MM, Roberts MC, Rapoff M, Boyer A. The efficacy of adherence interventions for chronically ill children: a meta-analytic review. J Pediatr Psychol. 2010 May;35(4):368-82. doi: 10.1093/jpepsy/jsp072. Epub 2009 Aug 26.
PMID: 19710248
citation: Luersen K, Davis SA, Kaplan SG, Abel TD, Winchester WW, Feldman SR. Sticker charts: a method for improving adherence to treatment of chronic diseases in children. Pediatr Dermatol. 2012 Jul-Aug;29(4):403-8. doi: 10.1111/j.1525-1470.2012.01741.x. Epub 2012 Apr 4.
PMID: 22471987
citation: Ismail N, Ratchford I, Proudfoot C, Gibbs J. Impact of a nurse-led clinic for chronic constipation in children. J Child Health Care. 2011 Sep;15(3):221-9. doi: 10.1177/1367493511406568. Epub 2011 Aug 9.
PMID: 21828166
citation: Arozullah AM, Yarnold PR, Bennett CL, Soltysik RC, Wolf MS, Ferreira RM, Lee SY, Costello S, Shakir A, Denwood C, Bryant FB, Davis T. Development and validation of a short-form, rapid estimate of adult literacy in medicine. Med Care. 2007 Nov;45(11):1026-33. doi: 10.1097/MLR.0b013e3180616c1b.
PMID: 18049342
responsible party type: Principal Investigator
investigator affiliation: Nemours Children's Clinic
investigator full name: Matthew Di Guglielmo
investigator title: Clinical Associate Professor of Pediatrics
mesh term: Constipation
sharing ipd: No
provided document: 