Recurrent Abdominal Pain in Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Shulman, M.D., Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00526903
First received: September 6, 2007
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Abdominal Pain
Irritable Bowel Syndrome
Behavioral: Elimination Diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Recurrent Abdominal Pain in Children

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Improvement in pain and stooling symptoms [ Time Frame: The last two weeks of treatment and up to 18 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Child anxiety, somatization, and coping [ Time Frame: Four weeks prior to treatment and 6 months after treatment ] [ Designated as safety issue: No ]
  • Parental somatization, coping, and illness interaction [ Time Frame: Four weeks prior to treatment and 6 months after treatment ] [ Designated as safety issue: No ]
  • Changes in GI Transit time [ Time Frame: Prior to and after treatment ] [ Designated as safety issue: No ]
  • Changes in Breath Hydrogen production [ Time Frame: Prior to and after treatment ] [ Designated as safety issue: No ]
  • Changes in GI Permeability [ Time Frame: Prior to and after treatment ] [ Designated as safety issue: Yes ]
  • Changes in fecal calprotectin concentration [ Time Frame: Prior to and after treatment ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: July 2007
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fiber
Fiber added to diet for a total of 6 weeks.
Behavioral: Elimination Diet
Daily diet change for 8 days.
Placebo Comparator: Placebo
Placebo powder taken for a total of 6 weeks.
Behavioral: Elimination Diet
Daily diet change for 8 days.

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. 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.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Allergy to red dye
  • Children taking a reflux medication that makes pain go away completely
  • Children with other chronic conditions (heart condition, diabetes)
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526903

Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Robert Shulman Baylor College of Medicine
  More Information

Additional Information:
Publications:
Czyzewski DI, Eakin MN, Lane MM, Jarrett M, Shulman RJ. Recurrent Abdominal Pain in Primary and Tertiary Care: Differences and Similarities. Child Health Care 2007;36:137-153.
McOmber M, Shulman RJ. Pediatric Functional Gastrointestinal Disorders. Nutr Clin Prac 2008; 23: 268-274.
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;123:758-764

Responsible Party: Robert Shulman, M.D., Professor of Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00526903     History of Changes
Other Study ID Numbers: 17388, R01NR005337, R01 NR005337
Study First Received: September 6, 2007
Last Updated: May 12, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
IBS
abdominal pain
recurrent abdominal pain
irritable bowel syndrome
diarrhea
constipation
bloating

Additional relevant MeSH terms:
Abdominal Pain
Irritable Bowel Syndrome
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014