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Lack of funding
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The colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the pediatric colonic microbiome are unknown. This study will determine whether acid suppression with these medications affects the microbiome of otherwise healthy children who are prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the duration and magnitude of microbiome changes.
Otherwise healthy children age 0-4 years old who are being considered for acid suppressive therapy for GERD will be eligible for this study. Subjects donate samples before and after being treated with PPIs or H2RAs (must donate at least 2 baseline pre-PPI samples to be eligible for final analysis). 30 total children who complete the study (anticipated 10 who receive lifestyle modification and 20 who receive PPIs or H2RAs). All children will donate 6 stools on or about weeks 0, 4, 12, 20, 38, and 64. The primary outcome will be a significant change in the overall diversity of the colonic microbiome after 8 weeks of PPIs or H2RAs (i.e., from week 12 to week 4), compared to after 4 weeks of lifestyle management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omeprazole (suspension) | Experimental | Open-label, with all subjects receiving omeprazole |
|
| Lifestyle Modification | Other | Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole (suspension) | Drug | 1 mg/kg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fecal Microbiome Diversity, Assessed by Bray-Curtis Index Comparing Those Who Received Acid Suppression Medications to Those Who Received Lifestyle Modifications | From week 12 to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Subjects Eating High Fiber Diet | At each study visit, we will assess the effects of longterm diet on the microbiome by using the Harvard-Willett Food Frequency Questionnaire. Using this data, we will classify each subject as low vs high fiber. | Up to Week 64 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julian S Abrams, MD, MS | Columbia University | Principal Investigator |
| Daniel E Freedberg, MD, MS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morgan Stanley Children's Hospital | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omeprazole (Suspension) | Open-label, with all subjects receiving omeprazole Omeprazole (suspension): 1 mg/kg/day |
| FG001 | Lifestyle Modification | Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.) Lifestyle Modification: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omeprazole (Suspension) | Open-label, with all subjects receiving omeprazole Omeprazole (suspension): 1 mg/kg/day |
| BG001 | Lifestyle Modification | Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.) Lifestyle Modification: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed |
| 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 | Change in Fecal Microbiome Diversity, Assessed by Bray-Curtis Index Comparing Those Who Received Acid Suppression Medications to Those Who Received Lifestyle Modifications | Zero participants analyzed as only 1 participant completed. Data was not analyzed and is not included here to protect the confidentiality of this one participant. | Posted | From week 12 to week 4 |
|
64 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omeprazole (Suspension) | Open-label, with all subjects receiving omeprazole Omeprazole (suspension): 1 mg/kg/day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel E. Freedberg, MD, MS | Columbia University | def2004@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Lifestyle Modification | Other | Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Percent Subjects Eating High Fiber Diet | At each study visit, we will assess the effects of longterm diet on the microbiome by using the Harvard-Willett Food Frequency Questionnaire. Using this data, we will classify each subject as low vs high fiber. | Zero participants analyzed as only 1 participant completed. Data was not analyzed and is not included here to protect the confidentiality of this one participant. | Posted | Up to Week 64 |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Lifestyle Modification | Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.) Lifestyle Modification: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed | 0 | 4 | 0 | 4 | 0 | 4 |
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| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |