Recurrent Abdominal Pain in Children

This study is currently recruiting participants.
Verified February 2013 by Baylor College of Medicine
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: February 4, 2013
Last verified: February 2013

September 6, 2007
February 4, 2013
July 2007
July 2013   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00526903 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Recurrent Abdominal Pain in Children
Recurrent Abdominal Pain in Children

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
  • Abdominal Pain
  • Irritable Bowel Syndrome
Behavioral: Elimination Diet
Daily diet change for 8 days.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
195
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
7 Years to 18 Years
No
Contact: Erica Baimbridge 713-798-0381 ewbaimbr@texaschildrenshospital.org
United States
 
NCT00526903
17388, R01NR005337, R01 NR005337
Yes
Robert Shulman, M.D., Baylor College of Medicine
Baylor College of Medicine
National Institute of Nursing Research (NINR)
Principal Investigator: Robert Shulman Baylor College of Medicine
Baylor College of Medicine
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP