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How Reflux Medications Affect the Microbiome of Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03747991
Recruitment Status : Completed
First Posted : November 20, 2018
Last Update Posted : August 21, 2019
Information provided by (Responsible Party):
Nemours Children's Clinic

Brief Summary:
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.

Condition or disease
GERD Dysbiosis

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Control Infants
Infants ages 2 months to 12 months who are not on H2RA medication.
Treated Infants
Infants ages 2 months to 12 months who are taking H2RA medication.

Primary Outcome Measures :
  1. Microbiome taxa [ Time Frame: At time of sampling - once at enrollment ]
    16S Metagenomic taxonomy of gut microbiome

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infants must be healthy, male or female term infants (gestational age ≥37 weeks) who are at least 2 months old, on or off H2RA medication, who meet inclusion/exclusion criteria. Infants will be recruited from Nemours Children's Clinic and through local advertisements in the greater Wilmington / Northern Delaware area.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03747991

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United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Sponsors and Collaborators
Nemours Children's Clinic
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Principal Investigator: Matthew Di Guglielmo, MD PhD Nemours

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Responsible Party: Nemours Children's Clinic Identifier: NCT03747991     History of Changes
Other Study ID Numbers: 1231469
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 16S metagenomic sequence data, deidentified, will be made available through either the database of Genotypes and Phenotypes (dbGap) or Sequence Read Archive (SRA).
Supporting Materials: Analytic Code
Time Frame: At conclusion of the study.
Access Criteria: To be determined.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nemours Children's Clinic:
Infant GERD
H2RA medication
Additional relevant MeSH terms:
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Pathologic Processes