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

NCT00619970 | Completed Results DMC

• 1 other identifier: CCI-06-00146
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Healthy Control

ACTIVE COMPARATOR

Healthy controls

Procedure: Lactulose Breath Test

Children receiving Rifaximin

ACTIVE COMPARATOR

2/3 Patients with CAP

Drug: xifaxan; Procedure: Lactulose Breath Test

Children receiving Placebo

PLACEBO COMPARATOR

1/3 patients with CAP

Drug: placebo; Procedure: Lactulose Breath Test

Interventions

Lactulose Breath Test PROCEDURE

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

Healthy Control

xifaxan DRUG

xifaxan 550mg TID x10days

Children receiving Rifaximin

placebo DRUG

placebo TID x 10days

Children receiving Placebo

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (1)

• 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.

  PMID: 21240023 DERIVED

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Brynie Slome Collins MD
• Organization: CHLA

bcollins@chla.usc.edu

323 361 2181

Study Officials

• Brynie S Collins, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 16, 2017
• Results First Posted: February 16, 2017

Record last verified: 2017-02

Locations

US (1)