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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06255886
Other study ID # OUH-HCA006
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2024
Est. completion date June 1, 2025

Study information

Verified date March 2024
Source Odense University Hospital
Contact Natalia K Barkholt, MD
Phone +45 50276171
Email Natalia.Barkholt@rsyd.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Description:

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Study Design


Intervention

Drug:
Protein pump inhibitor. Continuing nutrition containing cows' milk protein.
1 mg/kg /day
Behavioral:
Mother or infant diet
Mother on cow milk protein diet or infant on hypoallergenic formula in case of bottle fed
Drug:
Placebo
Placebo medicine (appearing substantially like Omeprazole) 1mg/ ml, and continuing nutrition containing cows' milk protein

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Odense University Hospital Hospital of Southern Jutland

Outcome

Type Measure Description Time frame Safety issue
Other Adverse events to trial medicine in the proton pump inhibitor group and the placebo group Any parent-reported adverse events to the trial medicine (both Omeprazole and placebo) are registered weekly.
There are several well-known side effects; 1-10 % experience symptoms from the gastrointestinal tract (i.e., stomach pain, nausea, and constipation), skin, airways, and increased susceptibility to infections.
1,2,3,4 weeks
Other Cows milk allergy? After 4 weeks´ of cows milk protein-free diet, an oral provocation test with cow's milk is conducted on all infants in the diet group, who experienced effect of the diet. The test will be carried out in the hospital. During the test, the infants are given increasing doses of fresh cow's milk every 30 minutes until they reach a maximum of 200 ml.
A nurse records any symptoms experienced during the first few hours of the test, and the parents are required to monitor and report any symptoms at home. Additionally, the parents inform the physician of any late symptoms via phone call 48 hours after the test.
4 weeks
Primary Change from baseline in reflux episodes Parent-reported reduction in the weekly number and size of reflux-episodes compared to placebo or the other active group, after four weeks of treatment. The outcome is registered daily in an App. Baseline and daily in 4 weeks.
Secondary Immunoglobulin E level Blood positive/negative for specific immunoglobulin E for cows milk protein. Values above 0,35 kU/l are considered positive for cows' milk allergy. 4 weeks after treatment is started
Secondary Change from baseline in weight A nurse or physician will perform the measurement on a weight in the clinic/hospital. Measurement unit: gram. Baseline and 4 weeks
Secondary Change from baseline in the number of reflux episodes with visible blood Parent reported weekly number of reflux episodes with visible blood. Registered in MyCap App. 1,2,3,4 weeks
Secondary Change from baseline in the number of episodes with discomfort Parent reported weekly episodes with discomfort 5 min after feeding. Registered in MyCap App 1,2,3,4 weeks
Secondary Change from baseline in the numbers of episodes with crying Parent reported weekly numbers of episodes with crying 5 minutes after feeding. Registered in MyCap App 1,2,3,4 weeks
Secondary Change from baseline in the number of episodes of refusing breast/ bottle Parent reported weekly numbers of episodes of refusing breast/bottle. Registered in MyCap App 1,2,3,4 weeks
Secondary Change from baseline in the number of episodes with short breathing pauses Parent-reported weekly numbers of episodes with short breathing pauses. Registered in MyCap App 1,2,3,4 weeks
Secondary Change from baseline in the number of episodes with paleness/blue color in face or lips Parent reported weekly numbers of episodes with paleness/blue color in face. Registered in MyCap App 1,2,3,4 weeks
Secondary Change from baseline in the number of episodes with troublesome breathing/cough Parent reported weekly numbers of episodes with troublesome breathing/cough. Registered in MyCap App 1,2,3,4 weeks
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