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Polaprezinc (Zinc L-carnosine) in Infants With Gastroesophageal Reflux
Sponsor: University of Roma La Sapienza
Summary
The goal of this clinical trial is to evaluate efficacy and safety of Zinc-L carnosine/Polaprezinc in infants with GER. Researchers will compare Zinc-L carnosine/Polaprezinc to a placebo (a look-alike substance that contains no drug) to see if Zinc-L carnosine/Polaprezinc works to treat infants with GER. Participants will: Take drug Zinc-L carnosine/Polaprezinc or a thickened formula every day for 8 weeks Visit the clinic once every 4 weeks for checkups and questionnaires
Official title: Efficacy and Safety of Polaprezinc/Zinc L-carnosine (Hepilor) in Infants With Gastroesophageal Reflux
Key Details
Gender
All
Age Range
1 Month - 12 Months
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-12-01
Completion Date
2025-07-01
Last Updated
2024-11-12
Healthy Volunteers
No
Conditions
Interventions
Zinc-L carnosine/Polaprezinc
This will be a randomised, single blind, controlled, multicenter study, designed to evaluate efficacy and safety of Zinc-L carnosine/Polaprezinc in infants (1-12 months of age) with symptoms suggestive of GER. This study will include a 2-week screening period, and a 8-week treatment period. After the screeing phase, eligible patients will be randomly assigned to either Zinc-L carnosine/Polaprezinc (Hepilor Liquido, Azienda Farmaceutica Italiana, Italy) twice a day or thickened formula, in a 1:1 ratio, for 8 weeks. Study visits will be conducted every 4 weeks during the treatment period.
Thickened formula
This will be a randomised, single blind, controlled, multicenter study, designed to evaluate efficacy and safety of Zinc-L carnosine/Polaprezinc in infants (1-12 months of age) with symptoms suggestive of GER. This study will include a 2-week screening period, and a 8-week treatment period. After the screeing phase, eligible patients will be randomly assigned to either Zinc-L carnosine/Polaprezinc (Hepilor Liquido, Azienda Farmaceutica Italiana, Italy) twice a day or thickened formula, in a 1:1 ratio, for 8 weeks. Study visits will be conducted every 4 weeks during the treatment period.