Clinical trial · Interventional
Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
NCT04614935CI-TRIAL-00057852completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We will be assessing for improvement in reported symptoms as well as reported quality of life in pediatric patients with functional constipation using a constipation action plan and an adherence log.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adherence, Medication | — | UNRESOLVED | — |
| Functional Constipation | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Survey, Family Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Action Plan | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Pediatric patients with functional constipation who are treated with medications and/or behavioral therapies as they would be if they were not enrolled in the study. In addition to standard of care treatment, these families will fill out a brief quality of life survey.
- type
- EXPERIMENTAL
- label
- Action Plan
- description
- Pediatric patients with functional constipation who are treated with standard of care medications and/or behavioral therapies and are also provided with a medication adherence log along with a constipation action plan. These families will also fill out a brief quality of life survey.
- interventionNames
- Behavioral: Action Plan
Primary outcomes (1)
- measure
- Medication and behavioral modification adherence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 8 Years
Show eligibility criteria text
Inclusion Criteria: * Have been potty-trained for stool at some point * Chief complaint constipation or encopresis * Meets Rome IV criteria for functional constipation Exclusion Criteria: * Preexisting diagnoses of autism, cerebral palsy, developmental delay, and/or thyroid disease * Prior gastrointestinal surgery * Presence of "red flag" symptoms for organic etiology: * Passage of meconium \>48 hours after birth in a term newborn * Family history of Hirschsprung's Disease * "Ribbon" stools * Blood in stools (in absence of anal fissure) * Coexisting diagnosis of malnutrition, bilious vomiting, abnormal anal positioning, absent anal reflex, decreased lower extremity strength/tone, sacral dimple, and/or tuft of hair on spine
References
Publications (5)
- BACKGROUNDFelt B, Wise CG, Olson A, Kochhar P, Marcus S, Coran A. Guideline for the management of pediatric idiopathic constipation and soiling. Multidisciplinary team from the University of Michigan Medical Center in Ann Arbor. Arch Pediatr Adolesc Med. 1999 Apr;153(4):380-5. doi: 10.1001/archpedi.153.4.380. PMID 10201721
- BACKGROUNDRasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063. PMID 16678566
- BACKGROUNDKoppen IJN, van Wassenaer EA, Barendsen RW, Brand PL, Benninga MA. Adherence to Polyethylene Glycol Treatment in Children with Functional Constipation Is Associated with Parental Illness Perceptions, Satisfaction with Treatment, and Perceived Treatment Convenience. J Pediatr. 2018 Aug;199:132-139.e1. doi: 10.1016/j.jpeds.2018.03.066. Epub 2018 May 10. PMID 29754864
- BACKGROUNDSteiner 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
- BACKGROUNDVarni JW, Bendo CB, Denham J, Shulman RJ, Self MM, Neigut DA, Nurko S, Patel AS, Franciosi JP, Saps M, Yeckes A, Langseder A, Saeed S, Pohl JF. PedsQL Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases in comparison to healthy controls. Qual Life Res. 2015 Feb;24(2):363-78. doi: 10.1007/s11136-014-0781-x. Epub 2014 Aug 23. PMID 25148757