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Recurrent Abdominal Pain in Childhood -Characteristics and Course

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00311233
First Posted: April 5, 2006
Last Update Posted: May 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Regionsenter for barn og unges psykiske helse
Information provided by:
Sykehuset Innlandet HF
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00311233     History of Changes
Other Study ID Numbers: 150063
First Submitted: April 3, 2006
First Posted: April 5, 2006
Last Update Posted: May 23, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
Abdominal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive