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

NCT06678997 | Completed

• 1 other identifier: HEPILOR PED
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gastroesophageal Reflux; Infants; Zinc-L carnosine/Polaprezinc

Outcome Measures

Primary Outcomes (1)

• I-GERQ-R questionnaire

  The primary outcome will be the quantitative improvement in Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) score from baseline to the end of the treatment period. The total score ranges from 0 to 42. A cut-off of ≥ 16 has been suggested to discriminate between GER and GER-disease.

  From enrollment to the end of treatment at 8 weeks.

Secondary Outcomes (1)

• Acceptability

  From enrollement to the end of treatment at 8 weeks.

Study Arms (2)

Zinc-L carnosine/Polaprezinc

EXPERIMENTAL

This group will receive Zinc-L carnosine/Polaprezinc (Hepilor Liquido) 1 hour after meals: 2.5 ml twice a day in infants weighing \<5 kg or 5 ml twice a day in infants weighing \>5 kg.

Device: Zinc-L carnosine/Polaprezinc

Thickened formula

ACTIVE COMPARATOR

Infants will receive thickened but not hydrolyzed formula

Other: Thickened formula

Interventions

Zinc-L carnosine/Polaprezinc DEVICE

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.

Also known as: Zinc-L carnosine/Polaprezinc (Hepilor Liquido)

Zinc-L carnosine/Polaprezinc

Thickened formula OTHER

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

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with infant regurgitation accoding to Rome IV criteria
• Healthy infants aged 1-12 months
• I-GERQ-R score ≥ 16 at baseline

You may not qualify if:

• Organic disease
• Current or pregress use of pharmacological treatment for gastric acid suppression or current use of thickened formula
• Past history of preterm birth or atopy
• Absence of informed consent

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: collaborator

Study Sites (1)

UOC Pediatria - Azienda Ospedaliero-Universitaria Sant'Andrea

Rome, Italy, 00189, Italy

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: December 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 5, 2026

Record last verified: 2024-11

Locations

IT (1)