Recurrent Abdominal Pain in Children
Condition: Abdominal Pain; Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Abdominal Pain
Study type: Interventional
Phase: Phase 2

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
    

Intervention name(s): Elimination Diet
Intervention type(s): Behavioral
Intervention description(s): Daily diet change for 8 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: IBS; abdominal pain; recurrent abdominal pain; irritable bowel syndrome; diarrhea; constipation; bloating