RecruitingNot Applicable

Pain in Pediatric Patients - Internet Interventions for Disorders of Gut-brain Interaction

Sweden200 participantsStarted 2025-12-01

Plain-language summary

Many children and adolescents often experience long-lasting stomach pain. In many cases, this is due to disorders of gut-brain interaction (DGBI), such as irritable bowel syndrome (IBS), functional abdominal pain, and functional dyspepsia. These conditions are caused by disrupted communication between the brain and the gut. They are linked to significant suffering, reduced quality of life, and higher school absenteeism. Psychological treatments such as cognitive behavioral therapy (CBT) have shown good effect, but waiting times within healthcare are often long. Therefore, there is a need for more accessible and cost-effective treatment alternatives. The goal of this clinical trial is to explore whether gut-directed hypnotherapy, already used successfully in the Netherlands, can be implemented as a new treatment option in Swedish healthcare. In addition, the study will compare gut-directed hypnotherapy with internet-based CBT (iCBT) to learn which digital treatment works best for children and adolescents with DGBI. Participants will: Be children or adolescents between 8 and 17 years old. First take part in a 4-week online education program called the "gut-school," which explains the stomach, the brain, and how symptoms can be managed. If symptoms remain after the gut-school, be randomly assigned to one of two digital treatments: iCBT (internet-based cognitive behavioral therapy). 10 week long. Gut-directed hypnotherapy, delivered as audio recordings to be used at home. 12 week long. Answer online survey questions before, during, and after treatment so researchers can follow their progress. These two treatments have never been directly compared. By comparing them, researchers hope to learn not only which treatment works best overall, but also which treatment is most suitable for different participants. The long-term aim is to make gut-directed hypnotherapy, already successful in the Netherlands, available as a treatment option in Sweden.

Who can participate

Age range

8 Years – 17 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: * Age 8-17 years * Basic somatic work-up completed (CRP/ESR, TGA, complete blood count, fecal calprotectin) * Confirmed DGBI diagnosis: IBS, functional abdominal pain, or functional dyspepsia (according to Rome IV criteria) * Any constipation must be treated according to current clinical guidelines, with stable laxative dosing for at least one month prior to referral * In cases of celiac disease, the participant must have followed a gluten-free diet for at least six months and TGA values must have normalized * For participants with a neuropsychiatric diagnosis treated with medication, at least two months must have passed since the last dose adjustment * At least one parent and the child/adolescent must be fluent in Swedish and willing to participate in both the educational program and treatment (regardless of randomization outcome), complete homework assignments, and respond to questionnaires Exclusion Criteria: * Other organic disease that better explains the gastrointestinal symptoms * At referral assessment, psychiatric symptoms or psychosocial problems - such as severe bullying, high school absenteeism, or difficult family circumstances - are judged to be more prominent than the gastrointestinal problems and require more extensive, multiprofessional care than what the study can offer * Participants who have already completed gut-directed hypnotherapy or CBT

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

Peds QL gastro

Timeframe: Assessments will be collected at baseline, after the gut-school (and before randomization), every third week during treatment (week 3, 6, 9 and 12), and at 6-month follow-up

Trial details

NCT IDNCT07319078

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-03

Contact for this trial

Tea Soini, MD PhD

+46 766457611 tea.soini@ki.se

View on ClinicalTrials.gov More Irritable Bowel Disease trials