Abdominal Symptom Phenotype Study in Children (ASPPNB)

This study has been completed.
Sponsor:
Collaborators:
University of Washington
Information provided by (Responsible Party):
Robert Shulman, M.D., Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01204515
First received: September 16, 2010
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

Children and adults commonly suffer from recurrent abdominal (stomach) pain. One type is called irritable bowel syndrome (IBS). IBS in adults and children is one of the most common and costly health care problems in the US. Some children have pain frequently (recurrent pain) while others rarely have pain. The investigators are conducting this study to help us answer questions about the causes and treatments, and management of IBS in children.

The purpose of this study is to find out if there is more than one type of IBS in children. If there is, this will be important in deciding the best treatments. The investigators also want to learn how children with IBS differ from those who do not have recurrent abdominal (stomach) pain.


Condition
Irritable Bowel Syndrome (IBS)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Abdominal Symptom Phenotype: Pathways to New Biomarkers

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Compare biomarkers (tests) on girls with and without IBS [ Time Frame: Two Days ] [ Designated as safety issue: No ]
    Biomarkers: Proteomic analysis of urine samples; Results of video capsule endoscopy (VCE) using the PillCam; Serum lymphocyte activation and cytokine levels (IL-8, IL-10 and IL-12) Responses to DNIC procedure;

  • Compare the response of stress in girls with and without IBS [ Time Frame: One Day ] [ Designated as safety issue: No ]
    Salivary cortisol levels prior to and after the diffuse noxious inhibitory control (DNIC) procedure; Psychological characteristics of the child and mother


Biospecimen Retention:   Samples With DNA

We will be banking DNA for future analysis. The samples will be retained according to the legal and ethical laws.


Enrollment: 45
Study Start Date: June 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Girls with IBS
Girls ages 7-12 years who meet Rome III criteria for IBS
Healthy Girls (controls)
Girls ages 7-12 years who are otherwise healthy and have no complaints of stomach pain

Detailed Description:

Functional gastrointestinal (GI) disorders (FGIDs), in particular irritable bowel syndrome (IBS) in adults and children, are among the most common and costly health care problems in the US. IBS disproportionately affects adult women (10-15% in western nations) and adolescent girls. Yet, health care providers remain challenged to provide effective clinical management. The etiology of IBS is not well defined and likely multi-factorial.

A Need to Define Subgroups of IBS:

This study emerges from the claim that identification of patient subgroups will advance our understanding of IBS and ultimately help develop treatment approaches. Most studies have lumped together patients with IBS into 2 groups (constipation-, diarrhea-predominant) and tested whether they differ from healthy controls. We propose that a paradigm shift is in order. We should recognize that IBS likely has multiple causes and therefore, multiple expressions. We speculate that by understanding better defined patient subgroups and linking them to newer biomarkers or tests, ultimately will further the understanding of the origins and create effective treatments.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We are studying only girls in this exploratory study because IBS is more common in girls than boys and the results of these studies can be compared with the results from studies of IBS in adults where the overwhelming number of patients are women.

Girls who meet the Rome III criteria for IBS or healthy girls with no complaints of stomach pain.

Criteria

Inclusion Criteria:

IBS:

  • Age 7-12 years
  • Females
  • Meet criteria for irritable bowel syndrome without evidence of organic disease
  • Developmentally normal
  • English speaking (as the psychological measures are either not available or validated in Spanish)
  • No other chronic, significant (e.g., diabetes, migraines) medical conditions
  • No menses

Controls:

  • Age 7-12 years
  • Females
  • No abdominal pain
  • No GI or chronic medical conditions (e.g., diabetes)
  • Developmentally normal
  • English speaking (as the psychological measures are not available or validated in Spanish)
  • No menses

Exclusion Criteria:

  • Non-english speaking
  • Developmentally or cognitively impaired
  • Males
  • Menses
  • No mother in the household for administration of the psychological measures
  • Use of any anti-depressants
  • History of migraines or chronic pain disorders
  • On narcotics for at least 1 week prior to enrollment
  • On any NSAIDs or pain reliever for at least 24 hours prior to enrollment
  • Sought psychotherapy in past 6 months for abdominal pain
  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: NCT01204515

Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
University of Washington
Investigators
Principal Investigator: Robert J Shulman, M.D. Baylor College of Medicine, Texas Children's Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Robert Shulman, M.D., Professor of Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01204515     History of Changes
Other Study ID Numbers: 25755, RC2NR011959
Study First Received: September 16, 2010
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
IBS
irritable bowel syndrome
abdominal pain
urgency
bloating
diarrhea
constipation

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014