How Reflux Medications Affect the Microbiome of Infants

NCT ID: NCT03747991

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-13
• Study Completion Date: 2019-07-31

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.

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.

Conditions

GERD; Dysbiosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Control Infants

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

No interventions assigned to this group

Treated Infants

Infants ages 2 months to 12 months who are taking H2RA medication.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Matthew Di Guglielmo

Chief, Division of General Academic Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Di Guglielmo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Nemours

Locations

Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States

Countries

United States

Other Identifiers

1231469

Identifier Type: -

Identifier Source: org_study_id