Skip to content

Abdominal Symptom Phenotype Study in Children

Abdominal Symptom Phenotype: Pathways to New Biomarkers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01204515
Acronym
ASPPNB
Enrollment
45
Registered
2010-09-17
Start date
2010-06-30
Completion date
2012-08-31
Last updated
2013-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

IBS, irritable bowel syndrome, abdominal pain, urgency, bloating, diarrhea, constipation

Brief summary

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.

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.

Interventions

None listed

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of Washington
CollaboratorOTHER
Baylor College of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
7 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Compare biomarkers (tests) on girls with and without IBSTwo DaysBiomarkers: 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 IBSOne DaySalivary cortisol levels prior to and after the diffuse noxious inhibitory control (DNIC) procedure; Psychological characteristics of the child and mother

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026