How Reflux Medications Affect the Microbiome of Infants
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|ClinicalTrials.gov Identifier: NCT03747991|
Recruitment Status : Completed
First Posted : November 20, 2018
Last Update Posted : August 21, 2019
|Condition or disease|
Gut microbiota dysbiosis is associated with diseases ranging from localized gastrointestinal disorders to neurologic, respiratory, metabolic, hepatic, and cardiovascular illnesses. The microbial colonization of the infant gut is known to play a key role in immunologic and metabolic pathways impacting on human health. Disruptions during the complex process of microbial colonization have been shown to increase disease susceptibility during life. A variety of factors are known to influence the gut microbiota, including mode of delivery of neonate, host genetic factors, hose immune response, diet, xenobiotics and other drugs, infections, and environmental microbial exposures.
The diagnosis of gastroesophageal reflux disease in the infant population has increased during the past two decades. Acid suppression medications are used commonly in infants for gastroesophageal reflux disease and other acid-related conditions despite little evidence of their efficacy. Multiple studies have shown adverse effects in pediatric patients using either proton pump inhibitors or H2 receptor antagonists, the two classes of acid suppression medications that are most frequently used in children. Some of these adverse effects may result from alterations in the microbiome caused by these medications. Prior studies have demonstrated significant changes in microbial composition of both gastric and intestinal microbiota with proton pump inhibitor use (5), but to the investigators' knowledge, no prior studies have looked at the effect of H2 receptor antagonists on the microbiome in healthy, full term infants.
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||Effect of Histamine-2 Receptor Antagonists on the Microbiome of Full Term Infants|
|Actual Study Start Date :||August 13, 2018|
|Actual Primary Completion Date :||April 30, 2019|
|Actual Study Completion Date :||July 31, 2019|
Infants ages 2 months to 12 months who are not on H2RA medication.
Infants ages 2 months to 12 months who are taking H2RA medication.
- Microbiome taxa [ Time Frame: At time of sampling - once at enrollment ]16S Metagenomic taxonomy of gut microbiome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747991
|United States, Delaware|
|Alfred I. duPont Hospital for Children|
|Wilmington, Delaware, United States, 19803|
|Principal Investigator:||Matthew Di Guglielmo, MD PhD||Nemours|