Treatment of Gastroesophageal Reflux Disease in Infants

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Gastroesophageal Reflux, Infant, Newborn, Diseases

In brief

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)

Key facts

Study ID

NCT06255886

Run by

Odense University Hospital

People needed

96

Starts

2025-10-27

Expected to finish

2026-12-26

Last updated by the study team

2025-11-20

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants diagnosed with gastroesophageal reflux disease (GERD)
• Age < 1 year at the time of referral
• Age >1 month at start of treatment
• At least 3 reflux episodes/daily in average
• At least one of following troublesome symptoms are present: Crying of unknown reason, discomfort/irritability, problems gaining weight/ weightloss, rejects the breast or bottle, apnea, back-arching.

You may not qualify if…

• Children with diagnosed or suspected syndrome /genetic disorder
• Congenital malformations (minor deformities are excepted)
• Abdominal surgery
• Metabolic disease
• Treatment with proton pump inhibitor within the last week
• Allergy for proton pump inhibitors
• Allergy for cow milk protein
• Infants on Cow's milk free diet

Where it is running

• Paediatric Department, Hospital of Southern Jutland — Aabenraa, Region Syddanmark, Denmark (enrolling)
• Børnelægecentret v/Kasper Dalby — Odense, Region Syddanmark, Denmark
• H.C Andersen Childrens' Hospital — Odense, Region Syddanmark, Denmark

Full record on ClinicalTrials.gov

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