Actively Recruiting
Treatment of Gastroesophageal Reflux Disease in Infants
Led by Odense University Hospital · Updated on 2025-11-20
96
Participants Needed
3
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Treatment of Gastroesophageal Reflux Disease in Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants diagnosed with gastroesophageal reflux disease (GERD)
- Age less than 1 year at the time of referral
- Age greater than 1 month at start of treatment
- At least 3 reflux episodes daily on average
- Presence of at least one troublesome symptom such as unexplained crying, irritability, poor weight gain or weight loss, refusal of breast or bottle, apnea, or back-arching
You will not qualify if you...
- Children with diagnosed or suspected syndrome or genetic disorder
- Presence of congenital malformations (minor deformities excepted)
- History of abdominal surgery
- Metabolic disease
- Treatment with proton pump inhibitors within the last week
- Allergy to proton pump inhibitors
- Allergy to cow milk protein
- Infants currently on a cow's milk protein-free diet
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Paediatric Department, Hospital of Southern Jutland
Aabenraa, Region Syddanmark, Denmark, 6200
Actively Recruiting
2
Børnelægecentret v/Kasper Dalby
Odense, Region Syddanmark, Denmark, 5000
Not Yet Recruiting
3
H.C Andersen Childrens' Hospital
Odense, Region Syddanmark, Denmark, 5000
Not Yet Recruiting
Research Team
N
Natalia K Barkholt, MD
CONTACT
G
Gitte Zachariassen, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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