Cow's-milk-protein-free diet versus omeprazole for reflux in infants
Treatment of Gastroesophageal Reflux Disease in Infants- a Randomized Controlled Trial
This test compares a cow's-milk-protein-free diet to the medicine omeprazole for infants under one year who have troublesome gastroesophageal reflux.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 1 Month to 1 Year |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 3 sites (Aabenraa, Region Syddanmark and 2 other locations) |
| Trial ID | NCT06255886 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Infants aged 1 to 11 months with diagnosed gastroesophageal reflux disease who have at least three reflux episodes per day and troublesome symptoms are ideal candidates.
Not a fit: Infants with known cow's milk protein allergy, recent PPI treatment, major congenital or metabolic disorders, or those already on a cow's-milk-free diet may not benefit from enrollment.
Why it matters
Potential benefit: If successful, this could reduce unnecessary PPI use and offer a safer dietary option that lowers symptoms and side effects in infants with GERD.
How similar studies have performed: Previous randomized studies in infants under one year are few and generally have not shown clear symptom benefit from PPIs, and recommendations for cow's-milk-protein-free diets are based on weak evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aabenraa, Region Syddanmark and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.