Recurrent Abdominal Pain in Children

Irritable Bowel Syndrome Clinical Trial

Official title:

Recurrent Abdominal Pain in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526903
• Other study ID #: 17388
• Secondary ID: R01NR005337
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2007
• Last updated: March 4, 2016
• Start date: January 2009
• Est. completion date: March 2014

Study information

• Verified date: March 2016
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abdominal Pain
• Irritable Bowel Syndrome

Intervention

Behavioral:
• Elimination Diet
Daily diet change for 8 days.

Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. Review. — View Citation

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. — 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

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. — 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 MA, Shulman RJ. Pediatric functional gastrointestinal disorders. Nutr Clin Pract. 2008 Jun-Jul;23(3):268-74. doi: 10.1177/0884533608318671. Review. — 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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in pain and stooling symptoms		The last two weeks of treatment and up to 18 months after treatment	No
Secondary	Child anxiety, somatization, and coping		Four weeks prior to treatment and 6 months after treatment	No
Secondary	Parental somatization, coping, and illness interaction		Four weeks prior to treatment and 6 months after treatment	No
Secondary	Changes in GI Transit time		Prior to and after treatment	No
Secondary	Changes in Breath Hydrogen production		Prior to and after treatment	No
Secondary	Changes in GI Permeability		Prior to and after treatment	Yes
Secondary	Changes in fecal calprotectin concentration		Prior to and after treatment	No

External Links

•   Information about Children in Clinical Research
•   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