Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255886
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-02-05
Brief Title:
Treatment of Gastroesophageal Reflux Disease in Infants
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Treatment of Gastroesophageal Reflux Disease in Infants- a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
An increasing number of infants less than one year of age have been referred to the pediatric departments with gastroesophageal reflux in the past decade Gastroesophageal reflux is a common condition in infants defined as the passage of gastric contents into the esophagus with regurgitation or vomiting Around 50 of infants younger than four months regurgitate or vomit regularly In most cases it is a harmless self-limiting condition in 90 of cases the symptoms diminish before 12 months However if reflux leads to troublesome symptoms or complications it is defined as gastroesophageal reflux disease Troublesome symptoms may include failure to thrive back arching food refusal regurgitation and irritability The prevalence of gastroesophageal reflux disease varies between studies Infants can be treated medically and proton pump Inhibitors have been recommended as the first choice However within the last few years there has been concern among pediatricians that too many infants are unnecessarily treated with this medication There are only a few randomized studies on proton pump inhibitor treatment in children under one year and most studies do not show a significant effect on symptoms Side effects of treatment with proton pump inhibitors include symptoms related to the gastrointestinal tract or airways increased susceptibility to infections and increased risk of developing allergy later in life Within the past years there has been attention to the overlapping of symptoms between gastroesophageal reflux disease and allergy to cow milk protein Cow-milk-protein allergy is the most common food allergy in early childhood with an estimated prevalence of 2-3 and presents with various symptoms predominantly from the skin and gastrointestinal tract Consequently cow-milk-protein allergy can be challenging to differentiate from gastroesophageal reflux disease Cow-milk-protein-allergy is an immune reaction and can be either immunoglobulin E-mediated presenting with immediate reaction including anaphylaxis or non-immunoglobulin E-mediated presenting with delayed symptoms In addition it is possible that cows milk can aggravate gastroesophageal reflux disease with a non-immunologic mechanism As there is no biomarker to differentiate non-immunoglobulin E-mediated cow-milk allergy from gastroesophageal reflux disease the diagnosis of non-immunoglobulin E-mediated cow-milk allergy can only be verified by an oral food challenge test preceded by a cow-milk-protein-elimination period Therefore in the updated international guidelines all children with gastroesophageal reflux disease should start with a 2-4-week cow-milk-protein-elimination diet before a proton pump inhibitor is prescribed However evidence is scarce on the effect of a cow-milk-protein-free diet in infants diagnosed with gastroesophageal reflux disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None