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Clinical trialNCT00619970CompletedInterventional

Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?

SponsorChildren's Hospital Los AngelesEnrollment115Chronic Abdominal PainSmall Intestinal Bacterial Overgrowth
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Chronic abdominal pain (CAP) is an extremely pervasive childhood condition and, like IBS in adults, it is one of the functional bowel disorders without a clear framework of understanding or an effective treatment. However, new research suggests that small intestinal bacterial overgrowth (SIBO) may be the unifying pathophysiology that explains the variety of symptoms experienced by patients with IBS. As CAP in children is believed to be a precursor to IBS in adults, we hypothesize that children with this disorder have a significantly greater prevalence of small intestinal bacterial overgrowth (SIBO) than normal, healthy children, and that eradication of bacterial overgrowth with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To prove this, we will first aim to determine the prevalence of SIBO in both healthy children and those with CAP. We will do this by performing a lactulose breath hydrogen test, the gold standard for the noninvasive measurement of SIBO, on 40 healthy controls and 80 subjects with CAP. We will then assess whether eradication of SIBO with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To do this we will randomize, in a double-blinded fashion, the 80 CAP patients to receive a 10-day course of either the antibiotic Rifaximin or a placebo. After completion of the treatment we will evaluate all these patients for eradication of bacterial overgrowth by repeating a lactulose breath hydrogen test. We will also assess for symptom improvement by re-administering questionnaires.

Investigators

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Childrens Hospital Los Angeles

    Los Angeles, California, United States

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Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

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Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Feb 2007
Primary completion
30 Sept 2008
Completion
30 Sept 2008
Last update posted
16 Feb 2017
Registered enrollment
115
Registry id
NCT00619970

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.