Status:
COMPLETED
Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?
Lead Sponsor:
Children's Hospital Los Angeles
Conditions:
Chronic Abdominal Pain
Small Intestinal Bacterial Overgrowth
Eligibility:
All Genders
8-18 years
Phase:
NA
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 effecti...
Eligibility Criteria
Inclusion
- Subjects must be between the ages of 8 and 18
- Subjects must be able to swallow pills
- Healthy Controls must be siblings, other family members or friends of the CAP subjects or children who are undergoing an overnight fast in order to obtain AM labs for another purpose other than this study.
- Female CAP subjects who are sexually active or who may become sexually active during the study will be required to practice an effective method of birth control (e.g., oral contraceptives, contraceptive patch or injection, IUD, double barrier method) before entering into the study.
- All CAP subjects must meet the Rome II Criteria for Functional Bowel Disorders Associated with Abdominal Pain or Discomfort in Children
Exclusion
- Subjects will be excluded if they:
- have a history of inflammatory bowel diseases, diabetes, cirrhosis or other liver disease, juvenile rheumatoid arthritis, systemic lupus, a history of bowel resection (including gastric, small bowel or colon; gallbladder surgery or appendectomy are NOT exclusion criteria).
- have been treated with antibiotics or probiotics within the past 2 months.
- have a history of TB infection or positive Mantoux test performed at screening
- have a history of allergy to rifampin or rifaximin
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00619970
Start Date
February 1 2007
End Date
September 1 2008
Last Update
February 16 2017
Active Locations (1)
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1
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027