CompletedNot Applicable

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

Italy60 participantsStarted 2024-12-01

Plain-language 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

Who can participate

Age range1 Month – 12 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

I-GERQ-R questionnaire

Timeframe: From enrollment to the end of treatment at 8 weeks.

Trial details

NCT IDNCT06678997

SponsorUniversity of Roma La Sapienza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-01

View on ClinicalTrials.gov More Gastroesophageal Reflux (GER) trials