Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth? (CAP&SIBO)

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT00619970
First received: January 25, 2008
Last updated: June 26, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
Chronic Abdominal Pain
Small Intestinal Bacterial Overgrowth
Procedure: Lactulose Breath Test
Drug: xifaxan
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?

Resource links provided by NLM:


Further study details as provided by Children's Hospital Los Angeles:

Primary Outcome Measures:
  • The prevalence of SIBO in children with CAP [ Time Frame: upon enrollment ] [ Designated as safety issue: No ]
  • To assess whether eradication of SIBO with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. [ Time Frame: 2 weeks, 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: February 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy Control
Healthy controls
Procedure: Lactulose Breath Test
Healthy controls will receive one lactulose breath test to assess for SIBO
Active Comparator: 2
2/3 Patients with CAP
Drug: xifaxan
xifaxan 550mg TID x10days
Placebo Comparator: 3
1/3 patients with CAP
Drug: placebo
placebo TID x 10days

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619970

Locations
United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
Principal Investigator: Brynie S Collins, MD Children's Hospital Los Angeles
  More Information

No publications provided by Children's Hospital Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brynie Collins, M.D, Childrens Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT00619970     History of Changes
Other Study ID Numbers: CCI-06-00146
Study First Received: January 25, 2008
Last Updated: June 26, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Rifaximin
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 17, 2014