An interventional study of comparison between use of mobile app and Patient-caregiver dyad using printed recommendations in Constipation - Functional, sponsored by Medical University of Gdansk. Completed at 1 site in Poland. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Supportive care
This randomized, double-blind clinical trial evaluates the effectiveness of use of a mobile health application in supporting the treatment of functional constipation in children aged 4 to 18 years. Participants are randomly assigned ( with en-bloc randomization) to either an intervention group using an interactive app with symptom tracking, reminders, and games or a control group using equivalent, but printed materials. The primary outcome is the improvement in constipation symptoms after 3 months with follow-up after 6 months (+/- 30 days) after enrollment. Secondary outcomes include achieving regular bowel movements. The study aims to determine whether digital tools can enhance treatment adherence and clinical outcomes in pediatric functional constipation.
Functional constipation is a common pediatric disorder that significantly affects the quality of life of children and their families. Despite the availability of evidence-based guidelines such as the Rome IV criteria and the ESPGHAN/NASPGHAN (European Society for Paediatric Gastroenterology, Hepatology and Nutrition/ North American Society for Paediatric Gastroenterology, Hepatology and Nutrition recommendations, treatment adherence remains a major challenge, often leading to suboptimal outcomes and chronic symptoms.
This randomized, double-blind, parallel-group clinical trial investigates the efficacy of a mobile health application designed to support the treatment of functional constipation in children. The study is conducted among children aged 4 to 18 years who meet the Rome IV diagnostic criteria for functional constipation. Participants are randomly allocated in a 1:1 ratio into two groups: an intervention group receiving standard care supplemented with an interactive mobile app, and a control group receiving standard care with a printed version of recommendations.
The interactive mobile app includes features aimed at increasing engagement and adherence, such as daily symptom tracking, medication and hydration reminders, educational content, diet guidance, and rewards to motivate participation. The printed materials are equivalent to app regarding information.
This trial aims to determine whether a digital intervention can meaningfully enhance treatment adherence and improve clinical outcomes in pediatric functional constipation, and potentially serve as a scalable tool for supporting families in managing this common chronic condition.
The primary endpoint is the improvement in constipation symptoms over 3 months and 6 months follow-up, assessed by measuring quality of life (measured using the PedsQL Gastrointestinal Module). Secondary outcome is the improvement (bowel movement frequency and stool consistency using the Bristol Stool Form Scale).
Data collection: Symptoms tracking - PedsQL Gastrointestinal Module, bowel movements, water intake, macrogol intake
*Mobile App Features:
Daily symptom tracking
Medication reminders
Diet and fluid intake tips
Games and reward system
Control: Identical interface without interactive features
Intervention scheme:
Visit 1 (enrolment, 0):
medical history, physical examination interpretation of laboratory findings (coeliac disease, vitamin D deficiency, hypercalcemia, hypothyroidism), which would exclude patient from study app presentation or printed materials introduction PedsQL Gastrointestinal Module fill-up
Visit 2 (after 1 month, 1)
medical history, physical examination counseling PedsQL Gastrointestinal Module fill-up and comparison of results from previous visit
Visit 3 (after another 1 month, 2)
medical history, physical examination PedsQL Gastrointestinal Module fill-up and comparison of results from previous visit
Visit 4 (after another 1 month, 3)
medical history, physical examination counseling PedsQL Gastrointestinal Module fill-up and comparison of results from previous visit
Visit 5 ( follow-up after 6 month of study, 6) medical history, physical examination counseling, program ending and final remarks PedsQL Gastrointestinal Module fill-up and comparison of results from previous visit
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Medical University of Gdansk is the lead sponsor of 130 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient-caregiver dyad receives standard care (optimal macrogol treatment) plus access to dedicated mobile app
Behavioral: comparison between use of mobile app
Patient-caregiver dyad receives standard care (optimal macrogol treatment) plus a non-interactive, educational-only printed version of recommendations.
Behavioral: Patient-caregiver dyad using printed recommendations
Patient-caregiver dyad receive standard care (optimal macrogol treatment) plus a mobile app featuring symptom tracking, medication reminders, dietary tips, and gamification elements.
Patient-caregiver dyad receives standard care ( optimal macrogol treatment) plus a non-interactive, educational-only printed version of recommendations.
improvement of symptoms
Decreased severity (measured by Likert scale, where 0 means never and 5 means almost always) of symptoms measured by PedsQL (Pediatric Quality of Life) - Gastrointestinal Module
Time frame: 6 month +/- 30 days
Achieving regularity of bowel movements
Number of participants with regular bowel movement (more than 2 bowel movements/week)
Time frame: 6 months +/-30 days
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — anyone contacting the authors will be assessed and data will be given to researchers/public authorities
Supporting information: Study protocol, Icf, Csr
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Medical University of Gdansk