Omeprazole for Gastroesophageal reflux disease | Cow's milk protein allergy

Inclusion criteria

• {"criterion_text":"- Age under 1 year\n- Diagnosed with GERD: 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.\n- >1 month old at start of the treatment"}

Exclusion criteria

• {"criterion_text":"- Children with a syndrome, or suspected syndrome/genetic disorder\n- Metabolic diseases\n- Congenital malformations (minor malformations in extremities excluded).\n- Abdominal surgery\n- Other major diseases (cardial, gastroenterologic, nefrologic, oncologic etc.)\n- Prior treatment with PPI (with in the last week)\n- Allergy to PPI\n- Already diagnozed with to cow's milk protein allergy\n- Children already on cow's milk free diet"}

Primary endpoints

• {"endpoint_text":"- Parent-reported reduction in the weekly number of reflux-episodes (compared to run-in) after four weeks treatment, in the active groups, compared to the control group (placebo). The outcome is registered daily in an App.","definition_or_measurement_approach":"Change from baseline in the weekly number of reflux episodes at week 4 as reported daily by parents and registered in an App."}

Secondary endpoints

• {"endpoint_text":"- Reduction of number of reflux episodes (compared to run-in) in the PPI group, compared to the diet group.","definition_or_measurement_approach":"Comparison of change from run-in in number of reflux episodes between PPI and diet groups, parent-reported (MyCap App)."}
• {"endpoint_text":"- Change from baseline in weight after 4 weeks. A nurse or physician will perform the measurement on a weight in the clinic/hospital. Measurement unit: gram.","definition_or_measurement_approach":"Weight measured by nurse or physician in clinic/hospital; change from baseline at 4 weeks (grams)."}
• {"endpoint_text":"- 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. [Time Frame: 1,2,3,4 weeks]","definition_or_measurement_approach":"Parent-reported weekly count of reflux episodes with visible blood, recorded in MyCap App at weeks 1–4; change from baseline."}
• {"endpoint_text":"- 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.[Time Frame: 1,2,3,4 weeks]","definition_or_measurement_approach":"Parent-reported weekly counts of episodes with crying 5 minutes after feeding, recorded in MyCap App at weeks 1–4; change from baseline."}
• {"endpoint_text":"- 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. [Time Frame: 1,2,3,4 weeks]","definition_or_measurement_approach":"Parent-reported weekly counts of refusal of breast/bottle, recorded in MyCap App at weeks 1–4; change from baseline."}
• {"endpoint_text":"- 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. [Time Frame: 1,2,3,4 weeks]","definition_or_measurement_approach":"Parent-reported weekly counts of short breathing pauses, recorded in MyCap App at weeks 1–4; change from baseline."}
• {"endpoint_text":"- 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. [Time Frame: 1,2,3,4 weeks]","definition_or_measurement_approach":"Parent-reported weekly counts of paleness/blue color in face or lips, recorded in MyCap App at weeks 1–4; change from baseline."}
• {"endpoint_text":"- 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. [Time Frame: 1,2,3,4 weeks]","definition_or_measurement_approach":"Parent-reported weekly counts of troublesome breathing/cough episodes, recorded in MyCap App at weeks 1–4; change from baseline."}
• {"endpoint_text":"- Change from baseline in the number of episodes with discomfort. Parent reported weekly episodes with discomfort 5 min after feeding. Registered in MyCap App. [Time Frame: 1,2,3,4 weeks]","definition_or_measurement_approach":"Parent-reported weekly counts of discomfort episodes 5 min after feeding, recorded in MyCap App at weeks 1–4; change from baseline."}
• {"endpoint_text":"- 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. [Time Frame: 4 weeks after treatment is started]","definition_or_measurement_approach":"Blood test for specific IgE to cow's milk protein at 4 weeks; positivity threshold >0.35 kU/l."}
• {"endpoint_text":"- Adverse events to trial medicine in the proton pump inhibitor group and the control (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. [Time Frame: 1,2,3,4 weeks]","definition_or_measurement_approach":"Parent-reported adverse events collected weekly for Omeprazole and placebo groups; recorded by parents (weekly)."}
• {"endpoint_text":"- Confirmation of 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. A nurse records any symptoms experienced during the first few hours of the test, and the parents are required to monitor and report any late symptoms via phone call 48 hours after the test.","definition_or_measurement_approach":"Oral provocation test in hospital after 4 weeks of diet for responders; nurse records immediate symptoms and parents report late symptoms by phone 48 hours post-test."}
• {"endpoint_text":"- Change from baseline in the size of reflux episodes. Registered in MyCap App daily.","definition_or_measurement_approach":"Parent-reported daily registration in MyCap App of size of reflux episodes; change from baseline."}

Denmark

Earliest CTIS Part Ii Submission Date

23-10-2024

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

520

Number Of Sites

4

Number Of Participants

96

Primary sponsor

Full Name

Odense University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":["1","7","8"],"organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Oresund Pharma ApS","duties_or_roles":["14"],"organisation_type":"Pharmaceutical company"}