Clinical trial NCT01204515: Abdominal Symptom Phenotype Study in Children
Official title: Abdominal Symptom Phenotype: Pathways to New Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: IBS
irritable bowel syndrome
abdominal pain
urgency
bloating
diarrhea
constipation
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: University of Washington
First posted: 2010-09-17
Enrollment: 45
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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: 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 criteria: 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

Primary outcomes:
measure: Compare biomarkers (tests) on girls with and without IBS
timeFrame: Two Days
measure: Compare the response of stress in girls with and without IBS
timeFrame: One Day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine - Texas Children's Hospital
name: Robert J Shulman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.