Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth? (CAP&SIBO)
Primary Purpose
Chronic Abdominal Pain, Small Intestinal Bacterial Overgrowth
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lactulose Breath Test
xifaxan
placebo
Lactulose Breath Test
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Abdominal Pain
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 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
Sites / Locations
- Childrens Hospital Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Healthy Control
Children receiving Rifaximin
Children receiving Placebo
Arm Description
Healthy controls
2/3 Patients with CAP
1/3 patients with CAP
Outcomes
Primary Outcome Measures
The Number of Participants at Baseline With SIBO
Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT00619970
First Posted
January 25, 2008
Last Updated
February 15, 2017
Sponsor
Children's Hospital Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT00619970
Brief Title
Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?
Acronym
CAP&SIBO
Official Title
Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Abdominal Pain, Small Intestinal Bacterial Overgrowth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Control
Arm Type
Active Comparator
Arm Description
Healthy controls
Arm Title
Children receiving Rifaximin
Arm Type
Active Comparator
Arm Description
2/3 Patients with CAP
Arm Title
Children receiving Placebo
Arm Type
Placebo Comparator
Arm Description
1/3 patients with CAP
Intervention Type
Procedure
Intervention Name(s)
Lactulose Breath Test
Intervention Description
Healthy controls will receive one lactulose breath test to assess for SIBO
Intervention Type
Drug
Intervention Name(s)
xifaxan
Intervention Description
xifaxan 550mg TID x10days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo TID x 10days
Intervention Type
Procedure
Intervention Name(s)
Lactulose Breath Test
Intervention Description
Children with CAP will receive one lactulose breath test to assess for SIBO and one after receiving either Rifaximin or Placebo
Primary Outcome Measure Information:
Title
The Number of Participants at Baseline With SIBO
Time Frame
upon enrollment
Title
Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment
Time Frame
baseline (week 0) and at 2 weeks post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brynie S Collins, MD
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21240023
Citation
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.
Results Reference
derived
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Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?
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