Recurrent Abdominal Pain in Children

March 4, 2016 updated by: Robert Shulman, M.D., Baylor College of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in pain and stooling symptoms
Time Frame: The last two weeks of treatment and up to 18 months after treatment
The last two weeks of treatment and up to 18 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Child anxiety, somatization, and coping
Time Frame: Four weeks prior to treatment and 6 months after treatment
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
Four weeks prior to treatment and 6 months after treatment
Changes in GI Transit time
Time Frame: Prior to and after treatment
Prior to and after treatment
Changes in Breath Hydrogen production
Time Frame: Prior to and after treatment
Prior to and after treatment
Changes in GI Permeability
Time Frame: Prior to and after treatment
Prior to and after treatment
Changes in fecal calprotectin concentration
Time Frame: Prior to and after treatment
Prior to and after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Robert Shulman, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 6, 2007

First Submitted That Met QC Criteria

September 7, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17388
  • R01NR005337 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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