Constipation - FunctionalNCT07025135
Evaluation of the Effectiveness of a Mobile Application in the Treatment of Children With Functional Constipation
A study testing comparison between use of mobile app and Patient-caregiver dyad using printed recommendations in people with Constipation - Functional, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- comparison between use of mobile app and Patient-caregiver dyad using printed recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 5 Feb 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 4-18,
- meeting Rome Criteria IV of functional constipation
Who cannot join
- organic causes of constipation
- comorbidities
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department and Clinic of Pediatrics, Gastroenterology, Allergology and Pediatric Nutrition of Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, 80-803
About this study
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.
Read the detailed description
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
- Conditions
- Constipation - Functional
- Being tested
- comparison between use of mobile app, Patient-caregiver dyad using printed recommendations
- Keywords
- functional constipation, pediatrics, mobile app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison between use of mobile appBehavioural
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 using printed recommendationsBehavioural
Patient-caregiver dyad receives standard care ( optimal macrogol treatment) plus a non-interactive, educational-only printed version of recommendations.
| Study group | Role | What they receive |
|---|---|---|
| patient-caregiver dyad using mobile app | Experimental | Patient-caregiver dyad receives standard care (optimal macrogol treatment) plus access to dedicated mobile app Receives: Behavioral: comparison between use of mobile app |
| patient-caregiver dyad using paper recommendation | Active comparator | Patient-caregiver dyad receives standard care (optimal macrogol treatment) plus a non-interactive, educational-only printed version of recommendations. Receives: Behavioral: Patient-caregiver dyad using printed recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month +/- 30 days
Secondary outcomes (1)
Achieving regularity of bowel movements
Number of participants with regular bowel movement (more than 2 bowel movements/week)
Measured: 6 months +/-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start5 Feb 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Constipation - FunctionalStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025135
- Sponsor's protocol ID
- NKBBN/920/2021
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: anyone contacting the authors will be assessed and data will be given to researchers/public authorities
Publications
Leszkowicz J, Nazar W, Wysokinska-Zakrzewska K, Zdun-Ryzewska A, Czadek-Asner P, Dettlaff-Dunowska M, Plata-Nazar K, Szlagatys-Sidorkiewicz A. Mobile app improves treatment of functional constipation in children: a randomized single-blind study. BMC Pediatr. 2025 Dec 9;25(1):980. doi: 10.1186/s12887-025-06385-y.
PubMed 41366315
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Mobile Application in the Treatment of Children With Functional Constipation
- ClinicalTrials.gov ID
- NCT07025135
- Acronym / sponsor ID
- NKBBN/920/2021
- Conditions
- Constipation - Functional
- Keywords
- functional constipation, pediatrics, mobile app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient-caregiver dyad using mobile app | Experimental | Behavioral: comparison between use of mobile appPatient-caregiver dyad receives standard care (optimal macrogol treatment) plus access to dedicated mobile app |
| patient-caregiver dyad using paper recommendation | Active comparator | Behavioral: Patient-caregiver dyad using printed recommendationsPatient-caregiver dyad receives standard care (optimal macrogol treatment) plus a non-interactive, educational-only printed version of recommendations. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age 4-18,
- meeting Rome Criteria IV of functional constipation
Key exclusion criteria (2 listed)
- organic causes of constipation
- comorbidities
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 |
|---|---|---|
| comparison between use of mobile appPatient-caregiver dyad receive standard care (optimal macrogol treatment) plus a mobile app featuring symptom tracking, medication reminders, dietary tips, and gamification elements. | Behavioural | patient-caregiver dyad using mobile app |
| Patient-caregiver dyad using printed recommendationsPatient-caregiver dyad receives standard care ( optimal macrogol treatment) plus a non-interactive, educational-only printed version of recommendations. | Behavioural | patient-caregiver dyad using paper recommendation |
Primary outcome
improvement of symptoms
Time frame: 6 month +/- 30 days
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
1 secondary outcome
Achieving regularity of bowel movements
Time frame: 6 months +/-30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Derived from this study: PubMed 41366315Leszkowicz J, Nazar W, Wysokinska-Zakrzewska K, Zdun-Ryzewska A, Czadek-Asner P, Dettlaff-Dunowska M, Plata-Nazar K, Szlagatys-Sidorkiewicz A. Mobile app improves treatment of functional constipation in children: a randomized single-blind study. BMC Pediatr. 2025 Dec 9;25(1):980. doi: 10.1186/s12887-025-06385-y.
- Individual participant dataSharing planned: Yes. anyone contacting the authors will be assessed and data will be given to researchers/public authorities
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparison between use of mobile app and Patient-caregiver dyad using printed recommendations in people with Constipation - Functional, run by Medical University of Gdansk at 1 site in Poland.
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 2 inclusion and 2 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 17 Jun 2025. 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 Poland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
improvement of symptoms (time frame: 6 month +/- 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07025135, which also lists 1 linked publication.
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 17 Jun 2025.