TerminatedNot Applicable

Effect of Acid Suppression Medication on Pediatric Microbiome

Stopped: Lack of funding

United States7 participantsStarted 2014-11

Plain-language summary

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.

Who can participate

Age range0 Years – 4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Fecal Microbiome Diversity, Assessed by Bray-Curtis Index Comparing Those Who Received Acid Suppression Medications to Those Who Received Lifestyle Modifications

Timeframe: From week 12 to week 4

Trial details

NCT IDNCT02016820

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01

Results submitted2023-12-05