Abdominal Symptom Phenotype Study in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome (IBS)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Girls with IBS

Girls ages 7-12 years who meet Rome III criteria for IBS

No interventions assigned to this group

Healthy Girls (controls)

Girls ages 7-12 years who are otherwise healthy and have no complaints of stomach pain

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes