Chronic Abdominal Pain, Small Intestinal Bacterial Overgrowth
Conditions
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.
Interventions
PROCEDURELactulose Breath Test
Healthy controls will receive one lactulose breath test to assess for SIBO
DRUGxifaxan
xifaxan 550mg TID x10days
DRUGplacebo
placebo TID x 10days
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Control Healthy controls | 40 |
| Children Receiving Rifaximin 2/3 Patients with CAP | 49 |
| Children Receiving Placebo 1/3 patients with CAP | 26 |
| Total | 115 |
Baseline characteristics
| Characteristic | Healthy Control | Children Receiving Rifaximin | Children Receiving Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 40 Participants | 49 Participants | 26 Participants | 115 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 40 participants | 49 participants | 26 participants | 115 participants |
| Sex: Female, Male Female | 25 Participants | 37 Participants | 18 Participants | 80 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 8 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 49 | 0 / 26 |
| serious Total, serious adverse events | 0 / 40 | 0 / 49 | 0 / 26 |
Outcome results
Primary
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
Population: 1 patient from the treatment group withdrew from the study. Four additional children, 2 from the treatment group and 2 from the placebo group, did not show up for their follow up breath test
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healthy Control | Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment | At baseline | 44 Participants |
| Healthy Control | Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment | 2 weeks | 37 Participants |
| Children Receiving Rifaximin | Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment | At baseline | 24 Participants |
| Children Receiving Rifaximin | Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment | 2 weeks | 19 Participants |
Primary
The Number of Participants at Baseline With SIBO
Time frame: upon enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Control | The Number of Participants at Baseline With SIBO | 14 Participants |
| Children Receiving Rifaximin | The Number of Participants at Baseline With SIBO | 44 Participants |
| Children Receiving Placebo | The Number of Participants at Baseline With SIBO | 24 Participants |