How Reflux Medications Affect the Microbiome of Infants

Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Age Range:Any
Start Date:August 13, 2018
End Date:August 31, 2019
Contact:Brittany Parlow, MD

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Effect of Histamine-2 Receptor Antagonists on the Microbiome of Full Term Infants

The changes in the organisms making up the gut microbiota in infants who are taking anti-acid
reflux medications (histamine 2 receptor antagonists) as compared to infants who are not
taking these medications is not well-studied or understood. Whether these medications change
the gut microbiota and microbiome, and what that change may imply for children on these
medications, is the focus of this study.

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.

Inclusion Criteria:

- Full term, at least 2 months of age

- No exposure OR at least 14 days of exposure to H2-receptor antagonist medication

- No exposure to probiotics or antibiotics

Exclusion Criteria:

- Current or recent (within the past 14 days) gastrointestinal infection (viral,
bacterial, or fungal)

- Gastrointestinal mucosal disease, or have clinically significant constipation

- Any history of exposure to proton pump inhibitors

- Unvaccinated infants

- Infants with weight-for-length either below the 3rd percentile for age or above the
97th percentile for age

- Infants with rapid weight gain, defined as change in weight-for-length z-score
exceeding +0.67 from birth to 4 months of age or birth to 6 months of age
We found this trial at
1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Phone: 302-651-5928
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
Wilmington, DE
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