Polaprezinc (Zinc L-carnosine) in Infants With Gastroesophageal Reflux

What Was Tested

This registered not phased trial tested Carnosine.

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.

It had two arms (groups): Zinc-L carnosine/Polaprezinc (experimental) and Thickened formula (active comparator).

Infants will receive thickened but not hydrolyzed formula.

The registry classes the interventions as device and other.

More on the Plan

The study will include a 2-week screening period, and a 8-week parallel arms treatment period.

After the screening phase, eligible patients will be randomly assigned to either thickened formula or polaprezing twice a day, in a 1:1 ratio, for 8 weeks.

Study visits will be conducted every 4 weeks during the treatment period.

All the subjects will be blindly allocated by means of scratch cards to one of the two treatment groups according to a computer-generated randomisation list provided by their statistician.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 1 Month up to 12 months.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with infant regurgitation accoding to Rome IV criteria. Healthy infants aged 1-12 months. I-GERQ-R score ≥ 16 at baseline.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: organic disease; past history of preterm birth or atopy; absence of informed consent.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Random assignment meant chance, not the researchers, decided who got Carnosine and who got the comparison, which limits bias.

The Carnosine group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Carnosine was given.

Those kept unaware of assignments: investigator.

It started in 2024-12-01 with completion listed for 2025-05-01.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): I-GERQ-R questionnaire (time frame: From enrollment to the end of treatment at 8 weeks).

It also tracked 1 secondary outcome, for example Acceptability.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carnosine in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carnosine compound page, all human trials.