How Reflux Medications Affect the Microbiome of Infants

NCT03747991 | Completed

• 1 other identifier: 1231469
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

GERD; Dysbiosis

Keywords

Infant GERD; H2RA medication

Outcome Measures

Primary Outcomes (1)

• Microbiome taxa

  16S Metagenomic taxonomy of gut microbiome

  At time of sampling - once at enrollment

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Dysbiosis

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Di Guglielmo, MD PhD

  Nemours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of General Academic Pediatrics

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 20, 2018
• Study Start: August 13, 2018
• Primary Completion: April 30, 2019
• Study Completion: July 31, 2019
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: At conclusion of the study.
• Access Criteria: To be determined.

Locations

US (1)