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Completed

NCT Number: NCT00526903

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.

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Texas Children's Hospital

Houston, Texas, 77030, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elimination Diet

Behavioral

Daily diet change for 8 days.

Primary outcomes

  1. Improvement in pain and stooling symptoms

    Time frame: The last two weeks of treatment and up to 18 months after treatment

Secondary outcomes

  1. Child anxiety, somatization, and coping

    Time frame: Four weeks prior to treatment and 6 months after treatment

  2. Parental somatization, coping, and illness interaction

    Time frame: Four weeks prior to treatment and 6 months after treatment

  3. Changes in GI Transit time

    Time frame: Prior to and after treatment

  4. Changes in Breath Hydrogen production

    Time frame: Prior to and after treatment

  5. Changes in GI Permeability

    Time frame: Prior to and after treatment

  6. Changes in fecal calprotectin concentration

    Time frame: Prior to and after treatment

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2007
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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