Abdominal Symptom Phenotype Study in Children

Irritable Bowel Syndrome (IBS) Clinical Trial

— ASPPNB  

Official title:

Abdominal Symptom Phenotype: Pathways to New Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204515
• Other study ID #: 25755
• Secondary ID: RC2NR011959
• Status: Completed
• Phase: N/A
• First received: September 16, 2010
• Last updated: February 4, 2013
• Start date: June 2010
• Est. completion date: August 2012

Study information

• Verified date: February 2013
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 7 Years to 12 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Nursing Research (NINR), University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Review. — View 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. Review. — View 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. — View Citation

McOmber ME, Shulman RJ. Recurrent abdominal pain and irritable bowel syndrome in children. Curr Opin Pediatr. 2007 Oct;19(5):581-5. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No

External Links

•   Information about Children in Clinical Research Studies
•   Information about Irritable Bowel Syndrome in Children
•   Information about Kids' GI Health
•   Information about the Digestive System
•   Our Research Group's website at Baylor College of Medicine