Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control | Active Comparator | Healthy controls |
|
| Children receiving Rifaximin | Active Comparator | 2/3 Patients with CAP |
|
| Children receiving Placebo | Placebo Comparator | 1/3 patients with CAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactulose Breath Test | Procedure | Healthy controls will receive one lactulose breath test to assess for SIBO |
|
| Measure | Description | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded if they:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brynie S Collins, MD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21240023 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Control | Healthy controls |
| FG001 | Children Receiving Rifaximin | 2/3 Patients with CAP |
| FG002 | Children Receiving Placebo | 1/3 patients with CAP |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Control | Healthy controls |
| BG001 | Children Receiving Rifaximin | 2/3 Patients with CAP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants at Baseline With SIBO | Posted | Count of Participants | Participants | upon enrollment |
|
8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Control | Healthy controls |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brynie Slome Collins MD | CHLA | 323 361 2181 | bcollins@chla.usc.edu |
Not provided
| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| xifaxan | Drug | xifaxan 550mg TID x10days |
|
| placebo | Drug | placebo TID x 10days |
|
| Lactulose Breath Test | Procedure | Children with CAP will receive one lactulose breath test to assess for SIBO and one after receiving either Rifaximin or Placebo |
|
| BG002 |
| Children Receiving Placebo |
1/3 patients with CAP |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment | 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 | Posted | Count of Participants | Participants | baseline (week 0) and at 2 weeks post treatment |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Children Receiving Rifaximin | 2/3 Patients with CAP | 0 | 49 | 0 | 49 |
| EG002 | Children Receiving Placebo | 1/3 patients with CAP | 0 | 26 | 0 | 26 |
Not provided
Not provided
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| 2 weeks |
|
|