CompletedNot Applicable

How Reflux Medications Affect the Microbiome of Infants

United States12 participantsStarted 2018-08-13

Plain-language 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.

Who can participate

Age range2 Months – 12 Months

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: * 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

What they're measuring

Microbiome taxa

Timeframe: At time of sampling - once at enrollment

Trial details

NCT IDNCT03747991

SponsorNemours Children's Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-04-30

View on ClinicalTrials.gov More GERD trials