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

NCT06678997 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-05

No results posted yet for this study

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

Conditions

  • Gastroesophageal Reflux (GER)
  • Infants

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

  • Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

    collaborator OTHER

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-05-01
Completion
2025-07-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06678997 on ClinicalTrials.gov