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Patient Education in Children With Functional Gastrointestinal Disorders

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Karolinska Institute

Status

Completed

Conditions

Functional Gastrointestinal Disorders

Treatments

Behavioral: Patient education program

Study type

Interventional

Funder types

Other

Identifiers

NCT04294420
2019-05417

Details and patient eligibility

About

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).

Full 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.

Enrollment

25 patients

Sex

All

Ages

8 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • Insufficient skills in the Swedish language.
  • Severe psychiatric comorbidity (as suicidality, psychosis etc).
  • Severe somatic comorbidity.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Patient education program
Experimental group
Description:
Patient education program
Treatment:
Behavioral: Patient education program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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