Adherence and Outcomes in Functional Constipation With a Constipation Action Plan (NCT04614935) | Clinical Trial Compass
CompletedNot Applicable
Adherence and Outcomes in Functional Constipation With a Constipation Action Plan
United States38 participantsStarted 2020-11-01
Plain-language summary
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.
Who can participate
Age range4 Years – 8 Years
SexALL
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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