Treatment of Gastroesophageal Reflux Disease in Infants
Launched by ODENSE UNIVERSITY HOSPITAL · Feb 12, 2024
Trial Information
Current as of July 24, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how effective a cow-milk-protein-free diet is for treating gastroesophageal reflux disease (GERD) in infants compared to a common medication called omeprazole, which is a proton pump inhibitor that reduces stomach acid. GERD can cause uncomfortable symptoms in babies, like frequent crying, trouble gaining weight, and irritability. While current guidelines suggest a cow-milk-protein-free diet may help, there isn’t strong evidence to support this, so the study aims to find out which treatment works better.
To participate in the trial, infants must be under one year old and have been diagnosed with GERD, experiencing at least three reflux episodes a day along with some troubling symptoms. However, infants with certain conditions, like genetic disorders or recent surgeries, won’t be eligible. If you decide to take part, your child will be monitored to see how well each treatment works and what effects they may have. It's important to know that the study is not yet recruiting participants, so there will be a wait before it officially begins.
Gender
ALL
Eligibility 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
About Odense University Hospital
Odense University Hospital is a leading academic medical center located in Denmark, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital is committed to enhancing patient outcomes and fostering collaboration among multidisciplinary teams. With a focus on translating scientific discoveries into practical applications, Odense University Hospital leverages its state-of-the-art facilities and expertise to conduct rigorous trials across various medical fields, ensuring adherence to the highest ethical and regulatory standards. Through these efforts, the hospital aims to contribute significantly to the global body of medical knowledge and improve the quality of care for patients both locally and internationally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Gitte Zachariassen, Professor
Study Director
H.C Andersen Childrens Hospital, Odense University Hospital and Syddansk University (SDU)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported