Ignite Creation Date:
2024-05-05 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00619970
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2008-01-25
Brief Title:
Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPSIBO
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None