Abdominal Symptom Phenotype Study in Children (ASPPNB)
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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 |
- 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 |
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.
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| 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 |
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 May 19, 2013