Recurrent Abdominal Pain in Children

• ClinicalTrials.gov Identifier: NCT00526903
• Recruitment Status: Completed
• First Posted: September 10, 2007
• Last Update Posted: March 8, 2016
• Sponsor: Baylor College of Medicine
• Collaborator: National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): Robert Shulman, M.D., Baylor College of Medicine

Tracking Information

• First Submitted Date: September 6, 2007
• First Posted Date: September 10, 2007
• Last Update Posted Date: March 8, 2016
• Study Start Date: January 2009
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 2, 2009): Improvement in pain and stooling symptoms [ Time Frame: The last two weeks of treatment and up to 18 months after treatment ]
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: September 2, 2009)

• Child anxiety, somatization, and coping [ Time Frame: Four weeks prior to treatment and 6 months after treatment ]
• Parental somatization, coping, and illness interaction [ Time Frame: Four weeks prior to treatment and 6 months after treatment ]
• Changes in GI Transit time [ Time Frame: Prior to and after treatment ]
• Changes in Breath Hydrogen production [ Time Frame: Prior to and after treatment ]
• Changes in GI Permeability [ Time Frame: Prior to and after treatment ]
• Changes in fecal calprotectin concentration [ Time Frame: Prior to and after treatment ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Recurrent Abdominal Pain in Children
• Official Title: Recurrent Abdominal Pain in Children

Brief Summary

The purpose of this study is to:

1. To determine if fiber versus placebo improves symptoms in children with recurrent abdominal pain/irritable bowel syndrome.
2. To determine possible ways fiber or placebo improve(s) symptoms in children with recurrent abdominal pain/irritable bowel syndrome by carrying out gastrointestinal tests and questionnaires.

Understanding how diet and fiber affect GI function potentially will benefit the large numbers of children with irritable bowel syndrome (IBS) and provide insight into prevention of IBS in at risk children. We expect that the results from these studies can be used to lessen significantly the huge financial burden to society caused by these chronic conditions.

Consent will be obtained from the parent/guardian and assent from the child.

Detailed Description

Children with recurrent abdominal pain (RAP) who meet the criteria for irritable bowel syndrome (IBS) will be recruited and studied. They will have been diagnosed by a pediatric gastroenterologist and will have had at least one healthcare visits in the past year for the complaint of abdominal pain.

Coordinators will come out to the family's home on an evening that is convenient. Both the parent and child will fill out some questionnaires. Next, the parent and child will get instructions on how to fill out a diary to record any stomach pain the child is having and what their stools look like. The child will also collect a stool sample during the regular diet and diary collection period. Once the child has completed the diary, the child will go on a special diet for eight days to remove foods that may cause stomach pain (foods and drinks containing lactose, fructose, and sorbitol will be eliminated).

Two weeks later, the coordinators will come out to the family's home again to review the pain and stool diary that the child kept while on the special diet. The coordinators will explain how to collect some samples of urine, stool, and breath. These tests will evaluate the gastrointestinal (GI) tract for inflammation and transit time. If the special diet does not make the stomach pain go away, the child will be selected at random, like the flip of a coin, to be placed in one of two groups: one group that receives fiber or one group that receives a placebo or sugar pill. Fiber has been suggested to help children with stomach pain.

After the child has been on the treatment for 6 weeks, he/she will keep another diary and collect another set of samples of urine, stool, and breath.

The children will be followed at 3 months, 6 months and 18 months after the treatment period.

Children will be asked to collect additional stools

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Diagnostic

Condition

• Abdominal Pain
• Irritable Bowel Syndrome

Intervention

Behavioral: Elimination Diet

Daily diet change for 8 days.

Study Arms

• Experimental: Fiber
  Fiber added to diet for a total of 6 weeks.
  Intervention: Behavioral: Elimination Diet
• Placebo Comparator: Placebo
  Placebo powder taken for a total of 6 weeks.
  Intervention: Behavioral: Elimination Diet

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.
• 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.
• Czyzewski DI, Eakin MN, Lane MM, Jarrett M, Shulman RJ, M D. Recurrent Abdominal Pain in Primary and Tertiary Care: Differences and Similarities. Child Health Care. 2007 May 2;36(2):137-153.
• 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.
• 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.
• McOmber ME, Shulman RJ. Recurrent abdominal pain and irritable bowel syndrome in children. Curr Opin Pediatr. 2007 Oct;19(5):581-5. Review.
• Kellermayer R, Tatevian N, Klish W, Shulman RJ. Steroid responsive eosinophilic gastric outlet obstruction in a child. World J Gastroenterol. 2008 Apr 14;14(14):2270-1.
• Amaizu N, Shulman R, Schanler R, Lau C. Maturation of oral feeding skills in preterm infants. Acta Paediatr. 2008 Jan;97(1):61-7. Epub 2007 Dec 3.
• McOmber MA, Shulman RJ. Pediatric functional gastrointestinal disorders. Nutr Clin Pract. 2008 Jun-Jul;23(3):268-74. doi: 10.1177/0884533608318671. Review.
• 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.
• Shulman RJ, Hollister EB, Cain K, Czyzewski DI, Self MM, Weidler EM, Devaraj S, Luna RA, Versalovic J, Heitkemper M. Psyllium Fiber Reduces Abdominal Pain in Children With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial. Clin Gastroenterol Hepatol. 2017 May;15(5):712-719.e4. doi: 10.1016/j.cgh.2016.03.045. Epub 2016 Apr 11.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 12, 2014): 168
• Original Estimated Enrollment (submitted: September 7, 2007): 195
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Children who have had at least one physician visit in the past year for abdominal pain or IBS symptoms.
• Children with recurrent abdominal pain who meet the criteria for irritable bowel syndrome.

Exclusion Criteria:

• Children who have another disease that accounts for stomach pain
• Current use of anti-inflammatory medication
• Children taking a GI medication that makes pain go away completely
• Children with other chronic conditions including chronic pain conditions (e.g. heart condition, diabetes)
• Children who have decreased growth
• GI blood loss
• Unexplained fever
• Chronic severe diarrhea
• Weight loss of > or = to 5% of body weight within 3 month prior to enrollment
• History of abdominal surgeries
• A history of suicide
• Cognitive impairment significantly below average age and/or grade level
• Non-English speaking parent or child
• Vomiting >2x/month
• Children currently in psychotherapy for abdominal pain.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00526903
• Other Study ID Numbers: 17388; R01NR005337 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Robert Shulman, M.D., Baylor College of Medicine
• Study Sponsor: Baylor College of Medicine
• Collaborators: National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Robert Shulman; Baylor College of Medicine

• PRS Account: Baylor College of Medicine
• Verification Date: March 2016