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GERD Infant Feeding Therapeutics Trial (GIFT Trial)

NCT06114836 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2026-05-05

No results posted yet for this study

Summary

The goal of this investigator-initiated, single-center, randomized controlled trial (RCT) is to compare the effects of four weeks of three therapies on clinical and mechanistic outcomes based on pH-Imp testing using a three-arm parallel design in NICU infants with objective GERD diagnosis. The three therapies being compared are natural maturation, proton pump inhibitor (PPI) use, and added rice (AR) formula use. The main goals are:

* to evaluate and compare the efficacy of the three commonly used treatment interventions used in the NICU for GERD in a randomized controlled manner with the primary endpoint of oral feeding success and absence of troublesome symptoms (as defined below).
* to characterize the mechanisms of primary end point (success or failure) using pH-Impedance metrics.

Conditions

  • GERD in Infants

Interventions

DRUG

Omeprazole

Omeprazole will be the PPI prescribed for 4 weeks.

OTHER

AR formula

Added rice formula will be ordered for 4 weeks.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
8 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06114836 on ClinicalTrials.gov