MedTrace Logo

Treatment of Gastroesophageal Reflux Disease in Infants

NCT06255886 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-11-20

No results posted yet for this study

Summary

Gastroesophageal reflux disease in infants is not fully understood. Infants are prescribed medical treatments that may not be effective or that contribute to adverse side effects and lead to concerns and expenses for the parents and healthcare system. Current guidelines recommend cow-milk-protein free diet as a first-line treatment, but these recommendations are based on weak evidence. This study investigate the efficacy of a cow-milk-protein free diet compared to treatment with a proton pump inhibitor (omeprazole)

Conditions

  • Gastroesophageal Reflux
  • Infant, Newborn, Diseases

Interventions

DRUG

Protein pump inhibitor.

1 mg/kg /day

BEHAVIORAL

Mother or infant diet

Mother on cow milk protein diet or infant on hypoallergenic formula in case of bottle fed

DRUG

Placebo

Placebo medicine (appearing substantially like Omeprazole) 1mg/ ml, and continuing nutrition containing cows' milk protein

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Gitte Zachariassen, Professor · H.C Andersen Childrens Hospital, Odense University Hospital and Syddansk University (SDU)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2026-12-26
Completion
2026-12-26

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

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 NCT06255886 on ClinicalTrials.gov