Abdominal Symptom Phenotype Study in Children (ASPPNB)
|ClinicalTrials.gov Identifier: NCT01204515|
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : February 6, 2013
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 or disease|
|Irritable Bowel Syndrome (IBS)|
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.
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Observational Model:||Case Control|
|Official Title:||Abdominal Symptom Phenotype: Pathways to New Biomarkers|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
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
- Compare biomarkers (tests) on girls with and without IBS [ Time Frame: Two Days ]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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204515
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert J Shulman, M.D.||Baylor College of Medicine, Texas Children's Hospital|