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

NCT ID: NCT00619970

Last Updated: 2017-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-09-30

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.

Conditions

Chronic Abdominal Pain; Small Intestinal Bacterial Overgrowth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Healthy Control

Healthy controls

Group Type: ACTIVE_COMPARATOR

Lactulose Breath Test

Intervention Type: PROCEDURE

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

Children receiving Rifaximin

2/3 Patients with CAP

Group Type: ACTIVE_COMPARATOR

xifaxan

Intervention Type: DRUG

xifaxan 550mg TID x10days

Lactulose Breath Test

Intervention Type: PROCEDURE

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

Children receiving Placebo

1/3 patients with CAP

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo TID x 10days

Lactulose Breath Test

Intervention Type: PROCEDURE

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

Interventions

Lactulose Breath Test

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

Intervention Type: PROCEDURE

xifaxan

xifaxan 550mg TID x10days

Intervention Type: DRUG

placebo

placebo TID x 10days

Intervention Type: DRUG

Lactulose Breath Test

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

Intervention Type: PROCEDURE

Eligibility 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 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Brynie Collins

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brynie S Collins, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Childrens Hospital Los Angeles

Los Angeles, California, United States

Countries

United States

References

Collins BS, Lin HC. Double-blind, placebo-controlled antibiotic treatment study of small intestinal bacterial overgrowth in children with chronic abdominal pain. J Pediatr Gastroenterol Nutr. 2011 Apr;52(4):382-6. doi: 10.1097/MPG.0b013e3181effa3b.

Reference Type: DERIVED

PMID: 21240023 (View on PubMed)

Other Identifiers

CCI-06-00146

Identifier Type: -

Identifier Source: org_study_id