Functional Abdominal Pain DisordersNCT02873078
Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders
A study testing Internet-delivered Cognitive behavior therapy in people with Functional Abdominal Pain Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This randomized controlled study aims to evaluate the efficacy of exposure-based Internet-delivered cognitive behavior therapy for children 8-12 years with Functional Abdominal Pain Disorders. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Functional Abdominal Pain Disorders
- What is being tested?
- Internet-delivered Cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2016to Jan 2018
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 8-12 years with either irritable bowel syndrome, functional dyspepsia or functional abdominal pain - not otherwise specified diagnosed according to Rome-III or Rome-IV criteria.
- Psychopharmacological medication stable for at least a month if medicating.
- Child and at least one parent speaking and writing swedish.
- Access to computer with Internet connection.
Who cannot join
- Severe somatic disorder and/or if the child fulfills criteria of other disorder that better explains the abdominal symptoms.
- Severe psychiatric or social problems that needs other care.
- Ongoing psychological treatment.
- School absenteeism more than 40 %.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-Delivered Cognitive Behavior Therapy for Children With Functional Abdominal Pain Disorders - a Randomized Controlled Trial
This randomized controlled study aims to evaluate the efficacy of exposure-based Internet-delivered cognitive behavior therapy for children 8-12 years with Functional Abdominal Pain Disorders. The children participate along with their parents, who will also receive specific modules with information on how to support their children in the treatment. Predictors and mediators for treatment effects will be studied as well as the cost effectiveness of the intervention.
- Conditions
- Functional Abdominal Pain Disorders
- Being tested
- Internet-delivered Cognitive behavior therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Cognitive behavior therapyBehavioural
The treatment is delivered via an online platform and is based on interventions for adults, adolescents and children tested in previous trials. Therapists are CBT-psychologists och students in clinical psychology under supervision.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered CBT | Experimental | Children and parents will receive 10 weekly modules of cognitive behavior therapy (CBT). Parents will also receive 10 weekly modules. Main components in the children's modules are exposure for abdominal symptoms, feared stimuli and situations in which the children are afraid of having symptoms. The parental receive information on how they can support their children in the treatment and how to reinforce health y behaviors and decrease attention to pain behaviors. Therapist support is provided through written messages within the secure platform. Receives: Behavioral: Internet-delivered Cognitive behavior therapy |
| Waiting list | No intervention | This is a wait-list control where the children and parents are allowed to carry on with any contacts within the health-care system, exempt for psychological treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PedsQL Gastro
Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Secondary outcomes (41)
Faces Pain Rating Scale
Change in pain intensity measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Faces Pain Rating Scale
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9).
Faces Pain Rating Scale rated by parents
Change in child's pain intensity measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Faces Pain Rating Scale rated by parents
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9).
PedsQL Gastro rated by parents
Change in child gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
PedsQL Gastro rated by parents
Change in child gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation.
Measured: Weekly during treatment (treatment week 1-9).
Pediatric quality of life inventory (PedsQL QOL)
Change in quality of life measured measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Pediatric quality of life inventory (PedsQL QOL) rated by parents
Change in child quality of life measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Painfree days
Change in pain free days measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Painfree days
Change in pain free days measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9)
Painfree days rated by parents
Change in child's pain free days measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Painfree days rated by parents
Change in child's pain free days measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9)
IBS-Behavioral responses questionnaire (IBS-BRQ)
Change in childs behavioral responses to abdominal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
IBS-Behavioral responses questionnaire (IBS-BRQ)
Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9)
IBS-Behavioral responses questionnaire (IBS-BRQ) parental version
Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
IBS-Behavioral responses questionnaire (IBS-BRQ) parental version
Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9)
Spence Children Anxiety Scale - short version (SCAS-S)
Change in child's anxiety symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Spence Children Anxiety Scale - short version (SCAS-S) rated by parents
Change in child's anxiety symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Child Depression Inventory - short version (CDI-S)
Change in child's depressive symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Visceral Sensitivity Index
Change in visceral sensitivity measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Visceral Sensitivity Index
Change in visceral sensitivity measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9)
Client Satisfactory Questionnaire (CSQ)
Client satisfaction rated measured with a self-rating scale
Measured: At week 10
Client Satisfactory Questionnaire (CSQ) rated by parents
Client satisfaction rated measured with a self-rating scale
Measured: At week 10
Subjective Assessment Questionnaire (SAQ)
Subjective change in symptoms measured with a self-rating scale
Measured: At week 10
Subjective Assessment Questionnaire (SAQ) rated by parents
Subjective change in the child's symptoms measured with a self-rating scale by the parents.
Measured: At week 10
Rome-IV questionnaire
Change in diagnostic status of functional abdominal pain disorder measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Kidscreen
Change in quality of life for use in economic evaluation measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
School absenteeism rated by parents
Change in child's school absenteeism measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
School absenteeism rated by parents
Change in child's school absenteeism measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9)
Pain Catastrophizing Scale, parental version (PCS-P)
Change in parental catastrophizing of the child's symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Pain Catastrophizing Scale, parental version (PCS-P)
Change in parental catastrophizing of the child's symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9)
Children´s Somatization Inventory (CSI 24) rated by parents
Change in child's somatization symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Adverse events (AE)
Adverse events during treatment measured with a self-rating scale by the parents.
Measured: At week 10
Working Alliance Inventory (WAI) short version
Working alliance in first three weeks of treatment measured with a self-rating scale by the parents.
Measured: At week 4
The treatment credibility scale rated by parents.
Treatment credibility measured with a self-rating scale by the parents.
Measured: At week 2
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) rated by parents
Costs associated with the disorder measured with a self-rating scale by the parents.
Measured: Baseline, at weeks 3, 7, 10 and at 9 months
General health questionnaire (GHQ-12) rated by parents
Change in general health measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Generalised anxiety disorder assessment (GAD 7) rated by parents
Change in parental anxiety symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Adult responses to children's symptoms (ARCS) rated by parents
Change in parental responses to child's symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Adult responses to children's symptoms (ARCS) rated by parents
Change in parental responses to child's symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9)
PedsQL Gastro
Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2018
- Study completionJan 2018
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 Functional Abdominal Pain DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Olen, Karolinska Institutet
- Investigators
- Ola Olén, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873078
- Sponsor's protocol ID
- RCT ICBT FAPD
- Status last verified
- Sep 2020
- First submitted
- 9 Aug 2016
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lalouni M, Ljotsson B, Bonnert M, Ssegonja R, Benninga M, Bjureberg J, Hogstrom J, Sahlin H, Simren M, Feldman I, Hedman-Lagerlof E, Serlachius E, Olen O. Clinical and Cost Effectiveness of Online Cognitive Behavioral Therapy in Children With Functional Abdominal Pain Disorders. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2236-2244.e11. doi: 10.1016/j.cgh.2018.11.043. Epub 2018 Nov 28.
PubMed 30502501
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Delivered Cognitive Behavior Therapy for Children With Functional Abdominal Pain Disorders - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02873078
- Acronym / sponsor ID
- RCT ICBT FAPD
- Conditions
- Functional Abdominal Pain Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 19 Aug 2016 (estimated)
- 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 controlled study aims to evaluate the efficacy of exposure-based Internet-delivered cognitive behavior therapy for children 8-12 years with Functional Abdominal Pain Disorders. The children participate along with their parents, who will also receive specific modules with information on how to support their children in the treatment. Predictors and mediators for treatment effects will be studied as well as the cost effectiveness of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered CBT | Experimental | Behavioral: Internet-delivered Cognitive behavior therapyChildren and parents will receive 10 weekly modules of cognitive behavior therapy (CBT). Parents will also receive 10 weekly modules. Main components in the children's modules are exposure for abdominal symptoms, feared stimuli and situations in which the children are afraid of having symptoms. The parental receive information on how they can support their children in the treatment and how to reinforce health y behaviors and decrease attention to pain behaviors. Therapist support is provided through written messages within the secure platform. |
| Waiting list | No intervention | –This is a wait-list control where the children and parents are allowed to carry on with any contacts within the health-care system, exempt for psychological treatments. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children 8-12 years with either irritable bowel syndrome, functional dyspepsia or functional abdominal pain - not otherwise specified diagnosed according to Rome-III or Rome-IV criteria.
- Psychopharmacological medication stable for at least a month if medicating.
- Child and at least one parent speaking and writing swedish.
- Access to computer with Internet connection.
Key exclusion criteria (4 listed)
- Severe somatic disorder and/or if the child fulfills criteria of other disorder that better explains the abdominal symptoms.
- Severe psychiatric or social problems that needs other care.
- Ongoing psychological treatment.
- School absenteeism more than 40 %.
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 |
|---|---|---|
| Internet-delivered Cognitive behavior therapyThe treatment is delivered via an online platform and is based on interventions for adults, adolescents and children tested in previous trials. Therapists are CBT-psychologists och students in clinical psychology under supervision. | Behavioural | Internet-delivered CBT |
Primary outcome
PedsQL Gastro
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
41 secondary outcomes
Faces Pain Rating Scale
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Faces Pain Rating Scale
Time frame: Weekly during treatment (treatment week 1-9).
Faces Pain Rating Scale rated by parents
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Faces Pain Rating Scale rated by parents
Time frame: Weekly during treatment (treatment week 1-9).
PedsQL Gastro rated by parents
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
PedsQL Gastro rated by parents
Time frame: Weekly during treatment (treatment week 1-9).
Pediatric quality of life inventory (PedsQL QOL)
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Pediatric quality of life inventory (PedsQL QOL) rated by parents
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Painfree days
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Painfree days
Time frame: Weekly during treatment (treatment week 1-9)
Painfree days rated by parents
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Painfree days rated by parents
Time frame: Weekly during treatment (treatment week 1-9)
IBS-Behavioral responses questionnaire (IBS-BRQ)
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
IBS-Behavioral responses questionnaire (IBS-BRQ)
Time frame: Weekly during treatment (treatment week 1-9)
IBS-Behavioral responses questionnaire (IBS-BRQ) parental version
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
IBS-Behavioral responses questionnaire (IBS-BRQ) parental version
Time frame: Weekly during treatment (treatment week 1-9)
Spence Children Anxiety Scale - short version (SCAS-S)
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Spence Children Anxiety Scale - short version (SCAS-S) rated by parents
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Child Depression Inventory - short version (CDI-S)
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Visceral Sensitivity Index
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Visceral Sensitivity Index
Time frame: Weekly during treatment (treatment week 1-9)
Client Satisfactory Questionnaire (CSQ)
Time frame: At week 10
Client Satisfactory Questionnaire (CSQ) rated by parents
Time frame: At week 10
Subjective Assessment Questionnaire (SAQ)
Time frame: At week 10
Subjective Assessment Questionnaire (SAQ) rated by parents
Time frame: At week 10
Rome-IV questionnaire
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Kidscreen
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
School absenteeism rated by parents
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
School absenteeism rated by parents
Time frame: Weekly during treatment (treatment week 1-9)
Pain Catastrophizing Scale, parental version (PCS-P)
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Pain Catastrophizing Scale, parental version (PCS-P)
Time frame: Weekly during treatment (treatment week 1-9)
Children´s Somatization Inventory (CSI 24) rated by parents
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Adverse events (AE)
Time frame: At week 10
Working Alliance Inventory (WAI) short version
Time frame: At week 4
The treatment credibility scale rated by parents.
Time frame: At week 2
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) rated by parents
Time frame: Baseline, at weeks 3, 7, 10 and at 9 months
General health questionnaire (GHQ-12) rated by parents
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Generalised anxiety disorder assessment (GAD 7) rated by parents
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Adult responses to children's symptoms (ARCS) rated by parents
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Adult responses to children's symptoms (ARCS) rated by parents
Time frame: Weekly during treatment (treatment week 1-9)
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 16 Sep 2020.
- Derived from this study: PubMed 30502501Lalouni M, Ljotsson B, Bonnert M, Ssegonja R, Benninga M, Bjureberg J, Hogstrom J, Sahlin H, Simren M, Feldman I, Hedman-Lagerlof E, Serlachius E, Olen O. Clinical and Cost Effectiveness of Online Cognitive Behavioral Therapy in Children With Functional Abdominal Pain Disorders. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2236-2244.e11. doi: 10.1016/j.cgh.2018.11.043. Epub 2018 Nov 28.
- Individual participant dataSharing planned: No
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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.
Ola Olén, MD PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered Cognitive behavior therapy in people with Functional Abdominal Pain Disorders, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 4 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 16 Sep 2020. 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 Sweden. 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?
PedsQL Gastro (time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months). 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 NCT02873078, 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 16 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.