Recurrent Abdominal Pain in Childhood -Characteristics and Course

This study has been completed.
Sponsor:
Collaborator:
Regionsenter for barn og unges psykiske helse
Information provided by:
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT00311233
First received: April 3, 2006
Last updated: May 22, 2008
Last verified: May 2008
  Purpose

Recurrent abdominal pain (RAP) is a common complaint in childhood. Identification of the processes that maintain illness is important.

The purpose of this study is to get more knowledge about characteristics of children with recurrent abdominal pain and their parents, and about the course of their pain. These results may be important to identify children who need treatment.


Condition
Abdominal Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Recurrent Abdominal Pain in Childhood, Characteristics and Course

Resource links provided by NLM:


Further study details as provided by Sykehuset Innlandet HF:

Biospecimen Retention:   Samples Without DNA

All patients have blood tests for hemoglobin, total leucocyte and differential count, sedimention rate, C-reactive protein, total IgE and IgE screen for food allergies, and antiendomysial and antigliadin antibodies (IgG and IgA) and anti-tissue transglutaminase antibodies for celiac disease. Furthermore, urine analyses for protein, blood and and leucocytes, three stool specimen for occult blood and one stool specimen for quantification of calprotectin.


Enrollment: 152
Study Start Date: February 2006
Study Completion Date: April 2008
Detailed Description:

BACKGROUND:

Recurrent abdominal pain (RAP), mainly constituted by functional gastrointestinal disorders (FGID), affects a significant number of children, and is a result of a complex interaction between biopsychosocial factors. Despite the seemingly benign nature of RAP, in some children RAP is associated with school absenteeism, functional impairment and frequent doctor visits. Identification of the processes that maintain illness is important. These results may be important to identify children who need treatment.

AIMS:

The aims of this study are to characterize children with RAP (in four out-patient clinics) and their parents, describe outcome and determine predictors of persistent RAP in children.

SAMPLE:

150 pediatric patients (4-15 years), their parents and teachers. Consecutive new patients referred to four pediatric out-patients clinics for evaluation of abdominal pain (primary complaint). Patients with RAP (abdominal pain at least once a month, in three consecutive months during the last year, and whose pains are severe enough to affect daily activity) are eligible.

DESIGN: A prospective cohort study.

MEASUREMENT:

All pediatric patients will undergo a complete physical examination emphasizing diagnosing organic illness and FGID according to the international ROME classification. Routine laboratory will be done. A protocol to identify somatic causes is part of the study. In addition, parents will complete validated questionnaires regarding their child`s physical/psychological health, temperamental characteristics and social skills and also psychosocial conditions concerning them selves. Self-report regarding the same aspects will be obtained from children above 8-9 years.

  Eligibility

Ages Eligible for Study:   4 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Study Population

Consecutive new pediatric patients (4-15 years) referred by their general practitioners to four pediatric out-patient clinics in Innlandet Hospital Health Authorities for evaluation of recurrent abdominal pain.

Criteria

Inclusion Criteria:

  • Consecutive new pediatric patients (4-15 years) referred by their general practitioners to four pediatric out-patient clinics in Innlandet Hospital Health Authorities for evaluation of recurrent abdominal pain.

Exclusion Criteria:

  • Known organic diagnosis for abdominal pain
  • Language problems (which will interfere completing questionnaires)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311233

Locations
Norway
Division of women and child and Division of Child and Adolescent Psychiatry, Innlandet Hospital Health Authorities
Gjovik, Norway, 2819
Sponsors and Collaborators
Sykehuset Innlandet HF
Regionsenter for barn og unges psykiske helse
Investigators
Study Chair: Trond Markestad, MD, Phd Eastern Norway Health Authorities, Innlandet Hospital Health Authorities
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00311233     History of Changes
Other Study ID Numbers: 150063
Study First Received: April 3, 2006
Last Updated: May 22, 2008
Health Authority: Norway: Eastern Norway Regional Health Authority
Norway: Innlandet Hospital, Health Authorities
Norway: Centre for Child and adolescent Mental Health, Eastern and Southern Norway

Keywords provided by Sykehuset Innlandet HF:
child
psychosocial
predictors
cohort
recurrent

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on September 16, 2014