- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01204515
Abdominal Symptom Phenotype Study in Children (ASPPNB)
Abdominal Symptom Phenotype: Pathways to New Biomarkers
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Girls with IBS
Girls ages 7-12 years who meet Rome III criteria for IBS
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Healthy Girls (controls)
Girls ages 7-12 years who are otherwise healthy and have no complaints of stomach pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare biomarkers (tests) on girls with and without IBS
Time Frame: Two Days
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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;
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Two Days
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Compare the response of stress in girls with and without IBS
Time Frame: One Day
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Salivary cortisol levels prior to and after the diffuse noxious inhibitory control (DNIC) procedure; Psychological characteristics of the child and mother
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One Day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert J Shulman, M.D., Baylor College of Medicine - Texas Children's Hospital
Publications and helpful links
General Publications
- Shulman RJ, Eakin MN, Jarrett M, Czyzewski DI, Zeltzer LK. Characteristics of pain and stooling in children with recurrent abdominal pain. J Pediatr Gastroenterol Nutr. 2007 Feb;44(2):203-8. doi: 10.1097/01.mpg.0000243437.39710.c0.
- Thakkar K, Gilger MA, Shulman RJ, El Serag HB. EGD in children with abdominal pain: a systematic review. Am J Gastroenterol. 2007 Mar;102(3):654-61. doi: 10.1111/j.1572-0241.2007.01051.x.
- Jarrett M, Heitkemper M, Czyzewski DI, Shulman R. Recurrent abdominal pain in children: forerunner to adult irritable bowel syndrome? J Spec Pediatr Nurs. 2003 Jul-Sep;8(3):81-9. doi: 10.1111/j.1088-145x.2003.00081.x.
- Burr RL, Motzer SA, Chen W, Cowan MJ, Shulman RJ, Heitkemper MM. Heart rate variability and 24-hour minimum heart rate. Biol Res Nurs. 2006 Apr;7(4):256-67. doi: 10.1177/1099800405285268.
- McOmber ME, Shulman RJ. Recurrent abdominal pain and irritable bowel syndrome in children. Curr Opin Pediatr. 2007 Oct;19(5):581-5. doi: 10.1097/MOP.0b013e3282bf6ddc.
- Shulman RJ, Eakin MN, Czyzewski DI, Jarrett M, Ou CN. Increased gastrointestinal permeability and gut inflammation in children with functional abdominal pain and irritable bowel syndrome. J Pediatr. 2008 Nov;153(5):646-50. doi: 10.1016/j.jpeds.2008.04.062. Epub 2008 Jun 9.
- Lane MM, Weidler EM, Czyzewski DI, Shulman RJ. Pain symptoms and stooling patterns do not drive diagnostic costs for children with functional abdominal pain and irritable bowel syndrome in primary or tertiary care. Pediatrics. 2009 Mar;123(3):758-64. doi: 10.1542/peds.2008-0227.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25755
- RC2NR011959 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome (IBS)
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Guy BoeckxstaensFund for Scientific Research, Flanders, BelgiumRecruiting
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Kyle Staller, MD, MPHArdelyxRecruitingIBS - Irritable Bowel Syndrome | IBSUnited States
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University of California, Los AngelesRecruitingIBS - Irritable Bowel SyndromeUnited States
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AstraZenecaCompletedIrritable Bowel Syndrome-IBSChina
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Arizona State UniversityCompletedIBS - Irritable Bowel SyndromeUnited States
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Xiyuan Hospital of China Academy of Chinese Medical...UnknownIBS (Irritable Bowel Syndrome)China
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Glycom, Inc.University of North CarolinaCompletedIrritable Bowel Syndrome (IBS)United States
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GlaxoSmithKlineCompletedIrritable Bowel Syndrome (IBS)United States
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