Recurrent Abdominal Pain in Children

Completed · Phase 2 · Has a placebo group

Conditions studied: Abdominal Pain, Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT00526903

Run by

Baylor College of Medicine

People needed

168

Starts

2009-01-01

Expected to finish

2014-03-01

Last updated by the study team

2016-03-08

Who can join

Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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