Cow's-milk-protein-free diet versus omeprazole for reflux in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Infants under one year with gastroesophageal reflux disease are assigned to a cow's-milk-protein-free diet, omeprazole treatment, or placebo, with symptoms and feeding/weight outcomes tracked during the treatment period. Inclusion requires at least three reflux episodes per day and presence of troublesome symptoms such as unexplained crying, poor weight gain, or back-arching. Exclusions include recent PPI use, diagnosed cow's milk protein allergy, certain congenital or metabolic conditions, and infants already on a cow's-milk-free diet. The trial compares symptom change, adverse events, and growth to see which approach reduces troublesome reflux while minimizing side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Paediatric Department, Hospital of Southern Jutland
  Aabenraa, Region Syddanmark, Denmark Recruiting
• Børnelægecentret v/Kasper Dalby
  Odense, Region Syddanmark, Denmark Not yet recruiting
• H.C Andersen Childrens' Hospital
  Odense, Region Syddanmark, Denmark Not yet recruiting

Study contacts

• Study coordinator: Natalia K Barkholt, MD
• Email: Natalia.Barkholt@rsyd.dk
• Phone: +4521787136

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.