Functional Gastrointestinal DisordersNCT04294420
Patient Education in Children With Functional Gastrointestinal Disorders
A study testing Patient education program in people with Functional Gastrointestinal Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This pilot-study aims to evaluate the effect size and feasibility of patient education for children and adolescents (age 8-17 years) with pain-predominant functional gastrointestinal disorders (irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Patient education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2020to 1 Dec 2021
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents between 8-17 years (until their 18th birthday) who have been diagnosed with any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional abdominal pain according to the Rome III criteria.
- Blood samples, with normal outcome, in terms of complete blood count (CBC), Erythrocyte Sedimentation Rate (ESR), Anti-tissue Transglutaminase Antibody (tTG), and dipstick urinalysis. Faecal Calprotectin should be measured if diarrhea is present.
Who cannot join
- Insufficient skills in the Swedish language.
- Severe psychiatric comorbidity (as suicidality, psychosis etc).
- Severe somatic comorbidity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Education in Children and Adolescents With Pain-predominant Functional Gastrointestinal Disorders: a Pilot Study
This pilot-study aims to evaluate the effect size and feasibility of patient education for children and adolescents (age 8-17 years) with pain-predominant functional gastrointestinal disorders (irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria).
Read the detailed description
The patient education will be provided in a group setting and the children will participate along with one of their parents. Education consists of 2-hour long group sessions, given at 2 different occasions within a month.
The hypothesis is that patient education will reduce gastrointestinal symptoms and pain and also improve quality of life in this group of patients.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- Patient education program
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education programBehavioural
The education program provides information and guidance concerning aetiology, diagnostics and treatment of pain-predominant functional gastrointestinal disorders. The patient education program will be provided in a group setting and the children will participate along with one of their parents. The participants (n=20) will be divided into two groups consisting of ten child-parent pairs. Two lectures will be held, two weeks apart, two hours per lecture. Represented teachers are physician, psychologist and dietician.
| Study group | Role | What they receive |
|---|---|---|
| Patient education program | Experimental | Patient education program Receives: Behavioral: Patient education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment acceptability
A questionnaire to child /adolescent if they found the education logic. If they believe it will decrease symptoms. If they would recommend it to others
Measured: Baseline to 3 months.
Secondary outcomes (8)
Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scales (PedsQL Gastro)
Change in gastrointestinal symptoms measured with with a 14-item scale ranging from 0 (never) to 4 (almost always) measured from baseline to three months and from baseline to six months for analysis of effect. Improvements yield increased values.
Measured: Baseline to 3 months, baseline to 6 months.
Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ)
Change in children's functional gastrointestinal disorders diagnostic status measured by Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ) - Child: Non-numerical self-report form for Children and Adolescents (10 years and older) measured from baseline to three months and from baseline to six months for analysis of effect as a self-rating scale from baseline to three months and from baseline to six months for analysis of effect.
Measured: Baseline to 3 months, baseline to 6 months.
Faces Pain Rating Scale. (FACES)
Change in pain intensity measured with a self-rating scale daily during two weeks at baseline, daily during two weeks after 3 months and daily during two weeks after 6 months for analysis of effect. The Faces Pain Scale is a self-report measure used to assess the intensity of children's pain. Faces have four faces representing least pain and most pain on equal intervals on a scale from 0 (no pain)-10 (worst pain). Its validity is supported by a strong positive correlation (r=0.93, N=76) with a visual analogue scale (VAS) measure in children aged 5-12 years. The metric for scoring (0-10) conforms closely to a linear interval scale.Higher scores indicates higher levels of pain.
Measured: Baseline to 3 months, baseline to 6 months.
Pediatric Quality of Life Inventory (PedsQL)
Change in quality of life from baseline to three months and from baseline to six months measured with a self-report scale that measures quality of life in adolescents. PedsQL Generic Core scales is a 23-item scale ranging from 0 (never) to 4 (almost always). Improvements yield increased values. The PedsQL is shown to distinguish between healthy children and adolescents and pediatric patients with acute or chronic health conditions and demonstrate acceptable reliability and validity.
Measured: Baseline to 3 months, baseline to 6 months.
The behavioral responses questionnaire child-adapted short scale (BRQ-C)
Change in Gastrointestinal symptom-specific behaviors measured with a self-rating scale from baseline to three months and from baseline to 6 months, for analysis of effect. The BRQ-C comprise 11 items on a 7 point-scale, with only endpoints defined: never (0) and always (7). Higher scores indicates higher levels of gastrointestinal symptoms.
Measured: Baseline to 3 months, baseline to 6 months.
Children's Somatization Inventory (CSI-24) - subscale for gastrointestinal symptoms (CSI gastro)
A questionnaire that assesses the perceived severity of 24 nonspecific somatic symptoms. Items are based off of the symptom criteria for somatization disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM). We will use the subscale for gastrointestinal symptoms (CSI gastro) with questions concerning presence of gastrointestinal symptoms measured with a 7-item scale ranging from 0 (not at all) to 4 (very much) measured from baseline to three months and from baseline to six months. Higher scores indicates higher levels of somatization.
Measured: Baseline to 3 months, baseline to 6 months.
Spence Children Anxiety Scale - short version (SCAS-S)
The SCAS-S assesses anxiety in children. The frequency of anxiety symptoms is rated on a 4-point scale, with answers ranging from never (0) to always (3). Higher scores indicates higher levels of anxiety. The SCAS-S will be assessed from baseline to three months and from baseline to six months.
Measured: Baseline to 3 months, baseline to 6 months.
Child Depression Inventory - short version (CDI-S)
Child Depression Inventory (CDI) is a self-measure of child depression symptoms. The short version of the CDI (CDI-S) consists of 10 items graded from 0 (no symptoms) to 2 (severe symptoms). The questionnaire covers depressive symptoms such as self-blame, loss of appetite and insomnia. The CDI-S has shown high correlation to other measures of depression and should be considered a valid measure of depression symptoms. Symptoms measured from baseline to three months and from baseline to six months. Higher scores indicates higher levels of depression.
Measured: Baseline to 3 months, baseline to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 May 2020
- Primary completion1 May 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agneta Uusijärvi, Karolinska Institutet
- Investigators
- Agneta Uusijärvi, MD PhD, Principal investigator, Karolinska Institute, CLINTEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294420
- Sponsor's protocol ID
- 2019-05417
- Other IDs
- 2019
- Status last verified
- Dec 2021
- First submitted
- 25 Feb 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education in Children and Adolescents With Pain-predominant Functional Gastrointestinal Disorders: a Pilot Study
- ClinicalTrials.gov ID
- NCT04294420
- Acronym / sponsor ID
- 2019-05417
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 4 Mar 2020 (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 pilot-study aims to evaluate the effect size and feasibility of patient education for children and adolescents (age 8-17 years) with pain-predominant functional gastrointestinal disorders (irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria).
Detailed description
The patient education will be provided in a group setting and the children will participate along with one of their parents. Education consists of 2-hour long group sessions, given at 2 different occasions within a month.
The hypothesis is that patient education will reduce gastrointestinal symptoms and pain and also improve quality of life in this group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient education program | Experimental | Behavioral: Patient education programPatient education program |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children and adolescents between 8-17 years (until their 18th birthday) who have been diagnosed with any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional abdominal pain according to the Rome III criteria.
- Blood samples, with normal outcome, in terms of complete blood count (CBC), Erythrocyte Sedimentation Rate (ESR), Anti-tissue Transglutaminase Antibody (tTG), and dipstick urinalysis. Faecal Calprotectin should be measured if diarrhea is present.
Key exclusion criteria (3 listed)
- Insufficient skills in the Swedish language.
- Severe psychiatric comorbidity (as suicidality, psychosis etc).
- Severe somatic comorbidity.
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 |
|---|---|---|
| Patient education programThe education program provides information and guidance concerning aetiology, diagnostics and treatment of pain-predominant functional gastrointestinal disorders. The patient education program will be provided in a group setting and the children will participate along with one of their parents. The participants (n=20) will be divided into two groups consisting of ten child-parent pairs. Two lectures will be held, two weeks apart, two hours per lecture. Represented teachers are physician, psychologist and dietician. | Behavioural | Patient education program |
Primary outcome
Treatment acceptability
Time frame: Baseline to 3 months.
A questionnaire to child /adolescent if they found the education logic. If they believe it will decrease symptoms. If they would recommend it to others
8 secondary outcomes
Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scales (PedsQL Gastro)
Time frame: Baseline to 3 months, baseline to 6 months.
Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ)
Time frame: Baseline to 3 months, baseline to 6 months.
Faces Pain Rating Scale. (FACES)
Time frame: Baseline to 3 months, baseline to 6 months.
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline to 3 months, baseline to 6 months.
The behavioral responses questionnaire child-adapted short scale (BRQ-C)
Time frame: Baseline to 3 months, baseline to 6 months.
Children's Somatization Inventory (CSI-24) - subscale for gastrointestinal symptoms (CSI gastro)
Time frame: Baseline to 3 months, baseline to 6 months.
Spence Children Anxiety Scale - short version (SCAS-S)
Time frame: Baseline to 3 months, baseline to 6 months.
Child Depression Inventory - short version (CDI-S)
Time frame: Baseline to 3 months, baseline to 6 months.
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 Dec 2021.
- 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.
Agneta Uusijärvi, MD PhD principal investigator
Karolinska Institute, CLINTEC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education program in people with Functional Gastrointestinal 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 2 inclusion and 3 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 Dec 2021. 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?
Treatment acceptability (time frame: Baseline to 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.