UnknownNot Applicable

Early Screening of Emotional, Behavioral and Autism Spectrum Disorders in Children With Functional Constipation.

Belgium100 participantsStarted 2018-01-12

Plain-language summary

A significant group of children with functional constipation (FC) continues to have symptoms despite recommended standard therapy. Underlying psychiatric problems could explain therapy resistance. However, a work-up for psychiatric problems is only recommended after unsuccessful 6 months standard therapy. Earlier detection and check-up could lead to faster start-up of a more adequate therapy. Therefore, we investigate the prevalence of emotional, behavioural and social problems in the FC-population at the first contact with a paediatric gastroenterologist in a tertiary care hospital.

Who can participate

Age range

4 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children presenting for the first time at the department of Pediatrics of the Universitair Kinderziekenhuis Brussel with complaints of constipation will be included regardless of previously diagnosed behavioral and developmental health problems and regardless of any previous treatment for functional defecation disorders. * Developmental age 4-18 years * Children and parents who express themselves fluently in Dutch or French * Children who meet the Rome IV criteria for the diagnosis of functional constipation in children * Children with developmental age of at least 4 years At least two of the following present at least once per week for at least one month. * Two or fewer defecations in the toilet per week * At least one episode of fecal incontinence per week * History of retentive posturing or excessive volitional stool retention * History of painful or hard bowel movements * Presence of a large fecal mass in the rectum * History of large-diameter stools that may obstruct the toilet * The symptoms cannot be fully explained by another medical condition. Exclusion Criteria: * Children with an underlying disease that could have contributed to the development of constipation: Celiac disease, Hypothyroidism, hypercalcemia, hypokalemia, Diabetes mellitus, Dietary protein allergy, Drugs, toxics, Vitamin D intoxication, Botulism, Cystic fibrosis, Hirschsprung Disease, Anal achalasia, Colonic inertia, Anatomic malformations, Pelvic mass (sacral teratoma), Sp…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The prevalence of internalizing and externalizing behavioural problems as assessed by the Aseba questionnaires

Timeframe: 1 year

The prevalence of behavioural and social responsiveness problems as assessed by the Social Responsiveness Scale-2.

Timeframe: 1 year

Trial details

NCT IDNCT03614000

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-12

Contact for this trial

Elisabeth Keuleneer

024776072 elisabeth.keuleneer@uzbrussel.be

View on ClinicalTrials.gov More Functional Constipation trials