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

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.

Study Overview

• Status: Completed
• Conditions: Small Intestinal Bacterial Overgrowth; Chronic Abdominal Pain
• Intervention / Treatment: Procedure: Lactulose Breath Test; Procedure: Lactulose Breath Test; Drug: xifaxan; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Childrens Hospital Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Healthy Control; Healthy controls	Procedure: Lactulose Breath Test; Healthy controls will receive one lactulose breath test to assess for SIBO; 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
ACTIVE_COMPARATOR: Children receiving Rifaximin; 2/3 Patients with CAP	Procedure: Lactulose Breath Test; Healthy controls will receive one lactulose breath test to assess for SIBO; 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; Drug: xifaxan; xifaxan 550mg TID x10days
PLACEBO_COMPARATOR: Children receiving Placebo; 1/3 patients with CAP	Procedure: Lactulose Breath Test; Healthy controls will receive one lactulose breath test to assess for SIBO; 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; Drug: placebo; placebo TID x 10days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Number of Participants at Baseline With SIBO	upon enrollment
Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment	baseline (week 0) and at 2 weeks post treatment

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Brynie S Collins, MD, Children's Hospital Los Angeles

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (ACTUAL): September 1, 2008
• Study Completion (ACTUAL): September 1, 2008

Study Registration Dates

• First Submitted: January 25, 2008
• First Submitted That Met QC Criteria: February 7, 2008
• First Posted (ESTIMATE): February 21, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin; Lactulose
• Other Study ID Numbers: CCI-06-00146