Treatment of Gastroesophageal Reflux Disease in Infants- a Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 1
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Paediatric Department, Hospital of Southern Jutland
RECRUITING
Aabenraa
Børnelægecentret v/Kasper Dalby
NOT_YET_RECRUITING
Odense
H.C Andersen Childrens' Hospital
NOT_YET_RECRUITING
Odense
Contact Information
Primary
Natalia K Barkholt, MD
Natalia.Barkholt@rsyd.dk
+4521787136
Backup
Gitte Zachariassen, Professor
Gitte.Zachariassen@rsyd.dk
+4565413809
Time Frame
Start Date: 2025-10-27
Estimated Completion Date: 2026-12-26
Participants
Target number of participants: 96
Treatments
Active_comparator: Proton pump inhibitor
Omeprazole 1 mg/ kg and continuing nutrition containing cow's milk protein
Active_comparator: Mother or infant diet
Mother on cow milk-protein-free diet if breastfeeding and infant on a hypoallergenic formula if bottle-fed.
Placebo_comparator: Placebo
Placebo medicine (appearing substantially like Omeprazole) 1mg/kg and continuing nutrition containing cow's milk protein
Sponsors
Leads: Odense University Hospital

This content was sourced from clinicaltrials.gov