Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?

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.

Conditions

• Chronic Abdominal Pain
• Small Intestinal Bacterial Overgrowth

Interventions

PROCEDURE

Lactulose Breath Test

Healthy controls will receive one lactulose breath test to assess for SIBO

DRUG

xifaxan

xifaxan 550mg TID x10days

DRUG

placebo

placebo TID x 10days

PROCEDURE

Lactulose Breath Test

Children with CAP will receive one lactulose breath test to assess for SIBO and one after receiving either Rifaximin or Placebo

Sponsors & Collaborators

• Children's Hospital Los Angeles

  lead OTHER

Principal Investigators

• Brynie S Collins, MD · Children's Hospital Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-02-28

Primary Completion

2008-09-30

Completion

2008-09-30

Countries

• United States

Study Locations