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NCT00619970 · ClinicalTrials.gov registry record · NA
Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?
A NA study, sponsored by Children's Hospital Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 115
- Enrollment target
NCT00619970 is a NA study that has completed, run by Children's Hospital Los Angeles. The registered enrollment target is 115 participants.
The verdict
NCT00619970, a NA study, has completed, sponsored by Children's Hospital Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 115 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG placebo
- PROCEDURE Lactulose Breath Test
- DRUG xifaxan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2007-02 |
| Est. Completion | 2008-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00619970
The ClinicalTrials.gov registry entry for NCT00619970 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00619970 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00619970 about?
NCT00619970 is a clinical study titled "Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?". 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 b...
What is the current status of trial NCT00619970?
This trial is currently completed. It is a NA study. The enrollment target is 115 participants. The study started on 2007-02. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00619970?
The interventions under investigation include: placebo (DRUG), Lactulose Breath Test (PROCEDURE), xifaxan (DRUG).
Who is sponsoring clinical trial NCT00619970?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
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