Treatment of Gastroesophageal Reflux Disease in Infants
Recruiting
Phase 4
Interventional Study
Gastroesophageal Reflux
Infant, Newborn, Diseases
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Month – 1
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 96 (estimated)
- Sponsor
- Odense University Hospital · Other
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About This Trial
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 …
Trial Locations
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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, dis…
Contacts