Gastroesophageal Reflux (GER)GERNCT06678997
Polaprezinc (Zinc L-carnosine) in Infants With Gastroesophageal Reflux
A study testing Zinc-L carnosine/Polaprezinc and Thickened formula in people with Gastroesophageal Reflux (GER) and Infants, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Gastroesophageal Reflux (GER), Infants
- What is being tested?
- Zinc-L carnosine/Polaprezinc and Thickened formula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with infant regurgitation accoding to Rome IV criteria
- Healthy infants aged 1-12 months
- I-GERQ-R score ≥ 16 at baseline
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
UOC Pediatria - Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, Italy, 00189
About this study
Official title: Efficacy and Safety of Polaprezinc/Zinc L-carnosine (Hepilor) in Infants With Gastroesophageal Reflux
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
Read the detailed description
This will be a randomised, single blind, controlled, study, designed to evaluate efficacy and safety of Zinc-L carnosine/Polaprezinc in infants (1-12 months of age) with symptoms suggestive of GER. 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 our statistician. A validated program will be used by an independent statistician to generate a randomisation list with blocks, block size=4, pre-allocated to centres. Only study investigators will be blinderd to the randomisation codes. The codes will be kept confidential until the end of the study when the randomisation code will be broken after the database lock. All subjects will undergo a formal clinical assessment. The protocol will be approved by and indipendent etichs committee and conducted according to the Declaration of Helsinki and the principles of good clinical practice.
Eligible patients with symptoms meeting Rome IV criteria for diagnosis of Infant Regurgitation will be recruited from Sant'Andrea University Hospital and from Children Hospital SS Antonio E Biagio E C. Arrigo.
The estimated total sample size that was aimed was 48 (24 children per arm) with the power of 80% (alpha of 5%). We estimated a dropout rate of 20% and aimed to recruit 60 participants to provide at least 48 evaluable assessments.
Efficacy analysis will be performed on ITT population. A sensitivity analysis on PP population will be carried out only if 5% or more ITT subjects are excluded from PP population.
Comparison between the two groups will be performed according to ANCOVA model. For all ANCOVA models, the assumptions of normality and homogeneity of variance will be investigated. Violation of these assumptions will be overcome by performing a non-parametric test (the Wilcoxon Rank Sum test).
Statistical analysis will be performed using the computer software SPSS 25.0
- Conditions
- Gastroesophageal Reflux (GER), Infants
- Being tested
- Zinc-L carnosine/Polaprezinc, Thickened formula
- Keywords
- Gastroesophageal Reflux, Infants, Zinc-L carnosine/Polaprezinc
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc-L carnosine/PolaprezincDevice
Also called Zinc-L carnosine/Polaprezinc (Hepilor Liquido)
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 formulaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Zinc-L carnosine/Polaprezinc |
| Thickened formula | Active comparator | Infants will receive thickened but not hydrolyzed formula Receives: Other: Thickened formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 8 weeks.
Secondary outcomes (1)
Acceptability
Secondary outcome will be the evaluation of product acceptability according to a five-point Likert scale, ranges from 1 (very poor) to 5 (very good)
Measured: From enrollement to the end of treatment at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Dec 2024
- Primary completion1 May 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux (GER)Studies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Responsible party
- Principal investigator, Prof. Giovanni Di Nardo, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678997
- Sponsor's protocol ID
- HEPILOR PED
- Acronym
- GER
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Piccirillo M, Mennini M, Felici E, Mauro A, Bernardo L, Baldassarre ME, Renzi E, De Vito C, Furio S, Graziani M, Quatrale G, Ferretti A, Di Nardo G. Zinc-L-Carnosine (Polaprezinc) in managing infant regurgitation: a two-center randomized controlled trial. Front Pediatr. 2026 Apr 21;14:1754324. doi: 10.3389/fped.2026.1754324. eCollection 2026.
PubMed 42093671
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Polaprezinc/Zinc L-carnosine (Hepilor) in Infants With Gastroesophageal Reflux
- ClinicalTrials.gov ID
- NCT06678997
- Acronym / sponsor ID
- GER / HEPILOR PED
- Conditions
- Gastroesophageal Reflux (GER), Infants
- Keywords
- Gastroesophageal Reflux, Infants, Zinc-L carnosine/Polaprezinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This will be a randomised, single blind, controlled, study, designed to evaluate efficacy and safety of Zinc-L carnosine/Polaprezinc in infants (1-12 months of age) with symptoms suggestive of GER. 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 our statistician. A validated program will be used by an independent statistician to generate a randomisation list with blocks, block size=4, pre-allocated to centres. Only study investigators will be blinderd to the randomisation codes. The codes will be kept confidential until the end of the study when the randomisation code will be broken after the database lock. All subjects will undergo a formal clinical assessment. The protocol will be approved by and indipendent etichs committee and conducted according to the Declaration of Helsinki and the principles of good clinical practice.
Eligible patients with symptoms meeting Rome IV criteria for diagnosis of Infant Regurgitation will be recruited from Sant'Andrea University Hospital and from Children Hospital SS Antonio E Biagio E C. Arrigo.
The estimated total sample size that was aimed was 48 (24 children per arm) with the power of 80% (alpha of 5%). We estimated a dropout rate of 20% and aimed to recruit 60 participants to provide at least 48 evaluable assessments.
Efficacy analysis will be performed on ITT population. A sensitivity analysis on PP population will be carried out only if 5% or more ITT subjects are excluded from PP population.
Comparison between the two groups will be performed according to ANCOVA model. For all ANCOVA models, the assumptions of normality and homogeneity of variance will be investigated. Violation of these assumptions will be overcome by performing a non-parametric test (the Wilcoxon Rank Sum test).
Statistical analysis will be performed using the computer software SPSS 25.0
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc-L carnosine/Polaprezinc | Experimental | Device: Zinc-L carnosine/PolaprezincThis 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. |
| Thickened formula | Active comparator | Other: Thickened formulaInfants will receive thickened but not hydrolyzed formula |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with infant regurgitation accoding to Rome IV criteria
- Healthy infants aged 1-12 months
- I-GERQ-R score ≥ 16 at baseline
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc-L carnosine/PolaprezincAlso: Zinc-L carnosine/Polaprezinc (Hepilor Liquido)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. | Device | Zinc-L carnosine/Polaprezinc |
| Thickened formulaThis 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 |
Primary outcome
I-GERQ-R questionnaire
Time frame: From enrollment to the end of treatment at 8 weeks.
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.
1 secondary outcome
Acceptability
Time frame: From enrollement to the end of treatment at 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 42093671Piccirillo M, Mennini M, Felici E, Mauro A, Bernardo L, Baldassarre ME, Renzi E, De Vito C, Furio S, Graziani M, Quatrale G, Ferretti A, Di Nardo G. Zinc-L-Carnosine (Polaprezinc) in managing infant regurgitation: a two-center randomized controlled trial. Front Pediatr. 2026 Apr 21;14:1754324. doi: 10.3389/fped.2026.1754324. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc-L carnosine/Polaprezinc and Thickened formula in people with Gastroesophageal Reflux (GER) and Infants, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-GERQ-R questionnaire (time frame: From enrollment to the end of treatment at 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06678997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.