Abdominal Symptom Phenotype Study in Children

Study Overview
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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.

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.

Official Title
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Abdominal Symptom Phenotype: Pathways to New Biomarkers

Conditions
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Irritable Bowel Syndrome (IBS)

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Girls with IBS<br>Girls ages 7-12 years who meet Rome III criteria for IBS | |
| Healthy Girls (controls)<br>Girls ages 7-12 years who are otherwise healthy and have no complaints of stomach pain | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare biomarkers (tests) on girls with and without IBS | 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; | Two Days | 
| Compare the response of stress in girls with and without IBS | Salivary cortisol levels prior to and after the diffuse noxious inhibitory control (DNIC) procedure; Psychological characteristics of the child and mother | One Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, irritable bowel syndrome, abdominal pain, urgency, bloating, diarrhea, constipation