Abdominal Symptom Phenotype Study in Children

NCT01204515 | Completed

• 2 other identifiers: 25755RC2NR011959
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

IBS; irritable bowel syndrome; abdominal pain; urgency; bloating; diarrhea; constipation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Nursing Research (NINR): collaborator
• University of Washington: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (7)

• 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.

  PMID: 17255832 BACKGROUND

• 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.

  PMID: 17222318 BACKGROUND

• 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.

  PMID: 12942886 BACKGROUND

• 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.

  PMID: 16581896 BACKGROUND

• 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.

  PMID: 17885479 BACKGROUND

• 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.

  PMID: 18538790 BACKGROUND

• 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.

  PMID: 19254999 BACKGROUND

Related Links

• Information about Kids' GI Health
• Information about Children in Clinical Research Studies
• Our Research Group's website at Baylor College of Medicine

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.

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain; Diarrhea; Constipation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Robert J Shulman, M.D.

  Baylor College of Medicine - Texas Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

US (1)