Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth? - Full Text View

Sponsored by:	Children's Hospital Los Angeles
Information provided by:	Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:	NCT00619970

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

MedlinePlus related topics: Abdominal Pain Antibiotics

Drug Information available for: Rifaximin Lactulose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?

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 ]

Estimated Enrollment:	120
Study Start Date:	February 2007
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Healthy Control: Active Comparator Healthy controls	Procedure: Lactulose Breath Test Healthy controls will receive one lactulose breath test to assess for SIBO
2: Active Comparator 2/3 Patients with CAP	Drug: xifaxan xifaxan 550mg TID x10days
3: Placebo Comparator 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

Contacts

Contact: Brynie S Collins, MD

322-361-4989

bcollins@chla.usc.edu

Locations

United States, California
Childrens Hospital Los Angeles	Recruiting
Los Angeles, California, United States, 90027
Principal Investigator: Brynie S Collins, MD

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

Responsible Party:	Childrens Hospital Los Angeles ( Brynie Collins, M.D )
Study ID Numbers:	CCI-06-00146
Study First Received:	January 25, 2008
Last Updated:	February 7, 2008
ClinicalTrials.gov Identifier:	NCT00619970 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Abdominal Pain

Rifaximin
Pain
Lactulose

Additional relevant MeSH terms:

Anti-Infective Agents
Signs and Symptoms
Signs and Symptoms, Digestive
Abdominal Pain
Therapeutic Uses

Gastrointestinal Agents
Rifaximin
Pain
Pharmacologic Actions
Lactulose

ClinicalTrials.gov processed this record on May 07, 2009