Evidence map›Paper›PMID 42093671›Full record

Trial reportFrontiers in pediatrics2026

Zinc-L-Carnosine (Polaprezinc) in managing infant regurgitation: a two-center randomized controlled trial.

Marisa Piccirillo, Maurizio Mennini, Enrico Felici, Angela Mauro, Luca Bernardo, Maria Elisabetta Baldassarre, Erika Renzi, Corrado De Vito, Silvia Furio, Marco Graziani and 3 more

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Frontiers in pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06678997 (Efficacy and Safety of Polaprezinc/Zinc L-carnosine), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06678997 nacompletednot on this map

Efficacy and Safety of Polaprezinc/Zinc L-carnosine (Hepilor) in Infants With Gastroesophageal Reflux

TypeinterventionalSponsorUniversity of Roma La SapienzaRan2024 to 2025Enrolled60ConditionsGastroesophageal Reflux (GER), InfantsArmsZinc-L carnosine/Polaprezinc, Thickened formula
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Marisa Piccirillo *Department of Neurosciences, Mental Health and Sensory Organs (NESMOS), Faculty of Medicine and Psychology, Sapienza University of Rome, Rome, Italy.
Maurizio Mennini *Department of Neurosciences, Mental Health and Sensory Organs (NESMOS), Faculty of Medicine and Psychology, Sapienza University of Rome, Rome, Italy.
Enrico FeliciPediatric Unit, Children's Hospital, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.
Angela MauroRheumatology Unit, Department of Childhood and Developmental Medicine, ASST Fatebenefratelli-Sacco, Milano, MI, United States.
Luca BernardoRheumatology Unit, Department of Childhood and Developmental Medicine, ASST Fatebenefratelli-Sacco, Milano, MI, United States.
Maria Elisabetta BaldassarreDepartment of Interdisciplinary Medicine, Neonatology and Neonatal Intensive Care Unit, "Aldo Moro" University of Bari, Bari, Italy.
Erika RenziDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.
Corrado De VitoDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.
Silvia FurioDepartment of Neurosciences, Mental Health and Sensory Organs (NESMOS), Faculty of Medicine and Psychology, Sapienza University of Rome, Rome, Italy.
Marco GrazianiDepartment of Neurosciences, Mental Health and Sensory Organs (NESMOS), Faculty of Medicine and Psychology, Sapienza University of Rome, Rome, Italy.
Giovanna QuatraleDepartment of Neurosciences, Mental Health and Sensory Organs (NESMOS), Faculty of Medicine and Psychology, Sapienza University of Rome, Rome, Italy.
Alessandro FerrettiDepartment of Neurosciences, Mental Health and Sensory Organs (NESMOS), Faculty of Medicine and Psychology, Sapienza University of Rome, Rome, Italy.
Giovanni Di NardoDepartment of Neurosciences, Mental Health and Sensory Organs (NESMOS), Faculty of Medicine and Psychology, Sapienza University of Rome, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Gastroesophageal reflux (GER) is a common physiological phenomenon in infants, typically self-limited, but often a source of parental concern. When non-pharmacological measures fail to improve symptoms, thickened formulas are commonly used. Zinc-L-carnosine (Polaprezinc) is a mucosal protectant with anti-inflammatory and antioxidant properties. It is widely used in gastrointestinal disorders in adults but has not yet been extensively studied in infants. We aim to evaluate the clinical effectiveness and cost impact of a Zinc-L-carnosine-based supplement (Hepilor liquido®) compared to thickened formula in infants with persistent regurgitation. Methods: This was a two-center, prospective, single-blind, randomized, non-inferiority study conducted in two Italian pediatric hospitals. Infants aged 4 weeks to 7 months with persistent regurgitation despite appropriate nutritional and behavioral management were randomized to receive either Hepilor liquido® or thickened formula for 8 weeks. The primary outcome was symptom improvement based on the I-GERQ-R (Infant Gastro-Esophageal Reflux Questionnaire-Revised) score. Secondary outcomes included a reduction in regurgitation frequency and treatment cost analysis. Results: Sixty infants aged 4 weeks to 7 months were randomized to receive either Hepilor liquido® ( Conclusions: Zinc-L-carnosine is a safe and effective alternative to thickened formula in treating persistent infant regurgitation, after the failure of non-pharmacological measures. Its lower cost and promising clinical effect support further investigation in larger pediatric cohorts. Clinical Trial Registration: https://clinicaltrials.gov/study/NCT06678997, identifier: NCT06678997.

Indexed as

gastroesophageal refluxinfant regurgitationpolaprezincthickened formulaZinc-L-carnosine

Identifiers

PMID42093671
PMCPMC13139114

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.