Effect of Acid Suppression Medication on Pediatric Microbiome
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 4 |
| Updated: | 4/2/2016 |
| Start Date: | November 2014 |
| End Date: | December 2016 |
| Contact: | Daniel E Freedberg, MD, MS |
| Email: | def2004@cumc.columbia.edu |
| Phone: | 212-342-0238 |
Effect of Proton Pump Inhibitors on the Colonic Microbiome in Children
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.
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.
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.
Inclusion Criteria:
- Zero to 4 years old
- Being considered for PPI or H2RA treatment for refractory GERD
- Parent is able to give informed consent
Exclusion Criteria:
- Prevalent C. difficile infection (excluded via stool PCR at week 0)
- Use of systemic antibiotics within the past 90 days
- Use of acid suppression medications within the past 90 days (antacids allowed if none
within the last 7 days)
- Increased risk for fracture due to vitamin D deficiency or other causes
- Chronic gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease,
microscopic colitis, malabsorptive conditions, short gut syndrome)
- Congenital deficiency in immunity (e.g., such as IgA deficiency)
- Cystic fibrosis
- Significant dynamic or uncontrolled comorbidity such as HIV or malignancy
- Use of medications with potential interaction with PPIs
We found this trial at
1
site
Click here to add this to my saved trials
