Evidence mapPaperPMID 39940951Full record

ArticleInternational journal of molecular sciences2025

A Non-Pharmacological Paradigm Captures the Complexity in the Mechanism of Action of Poliprotect Against Gastroesophageal Reflux Disease and Dyspepsia.

Sara Caterbi, Claudio Buttarini, Stefano Garetto, Isabelle Franco Moscardini, Stefano Ughetto, Angela Guerrini, Elena Panizzi, Cristiano Rumio, Laura Mattioli, Marina Perfumi and 7 more

Abstract read
In one paragraph

Article in International journal of molecular sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Natural Compounds for Counteracting GI and Liver Diseases.International journal of molecular sciences · 2026
    Article
  2. Molecules (Basel, Switzerland) · 2026
    Article
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

17 authors.

Sara CaterbiBios-Therapy, Physiological Systems for Health S.p.A., Località Aboca 20, 52037 Sansepolcro, Italy.
Claudio ButtariniBios-Therapy, Physiological Systems for Health S.p.A., Località Aboca 20, 52037 Sansepolcro, Italy.
Stefano GarettoBios-Therapy, Physiological Systems for Health S.p.A., Località Aboca 20, 52037 Sansepolcro, Italy.
Isabelle Franco MoscardiniBios-Therapy, Physiological Systems for Health S.p.A., Località Aboca 20, 52037 Sansepolcro, Italy.
Stefano UghettoBios-Therapy, Physiological Systems for Health S.p.A., Località Aboca 20, 52037 Sansepolcro, Italy.
Angela GuerriniBios-Therapy, Physiological Systems for Health S.p.A., Località Aboca 20, 52037 Sansepolcro, Italy.
Elena PanizziBios-Therapy, Physiological Systems for Health S.p.A., Località Aboca 20, 52037 Sansepolcro, Italy.
Cristiano RumioDepartment of Pharmacology and Biomolecular Sciences, University of Milan, Via Trentacoste 2, 20134 Milan, Italy.ORCID 0000-0002-2593-7620
Laura MattioliDepartment of Experimental Medicine and Public Health, University of Camerino, Via Madonna delle Carceri 9, 62032 Camerino, Italy.
Marina PerfumiDepartment of Experimental Medicine and Public Health, University of Camerino, Via Madonna delle Carceri 9, 62032 Camerino, Italy.
Anna MaidecchiAboca S.p.A, Società Agricola, Località Aboca 20, 52037 Sansepolcro, Italy.
Andrea CossuAboca S.p.A, Società Agricola, Località Aboca 20, 52037 Sansepolcro, Italy.
Stanislas Bruley des VarannesDepartment of Gastroenterology Hepatology and Clinical Oncology, Institut des Maladies de l'Appareil Digestif, Universitary Hospital, 44000 Nantes, France.
Jaroslaw RegulaDepartment of Oncological Gastroenterology, Maria Sklodowska-Curie National Research Institute of Oncology, 00-001 Warsaw, Poland.ORCID 0000-0001-7071-3151
Peter MalfertheinerLMU Klinikum Medizinische Klinik und Poliklinik II, Campus Großhadern, Marchioninistr. 15, 81377 München, Germany.
Claudia SardiBios-Therapy, Physiological Systems for Health S.p.A., Località Aboca 20, 52037 Sansepolcro, Italy.
Jacopo LucciBios-Therapy, Physiological Systems for Health S.p.A., Località Aboca 20, 52037 Sansepolcro, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

When the protective mechanisms of the gastroesophageal mucosa are overwhelmed by injurious factors, the structural and functional mucosal integrity is compromised, resulting in a wide spectrum of disorders. Poliprotect has recently been shown to be non-inferior to standard-dose omeprazole for the treatment of endoscopy-negative patients with heartburn and/or epigastric pain or burning. Here, we provide preclinical data describing the mechanism of action of the Poliprotect formulation, a 100% natural, biodegradable, and environmental friendly medical device according to EU 2017/745 and containing UVCB (unknown or variable composition, complex-reaction products, or biological materials) substances of botanical and mineral origin, according to the REACH and European Chemical Agency definitions. Different in vitro assays demonstrated the capability of Poliprotect to adhere to mucus-secreting gastric cells and concomitantly deliver a local barrier with buffering and antioxidant activity. In studies conducted in accordance with systems biology principles, we evaluated the effects of this barrier on human gastric cells exposed to acidic stress. Biological functions identified via Ingenuity Pathway Analysis highlighted the product's ability to create a microenvironment that supports the mucosal structural and functional integrity, promotes healing, and restores a balanced mucosal inflammatory status. Additionally, transepithelial electrical resistance and an Ussing chamber showed the product's capability of preserving the integrity of the gastric and esophageal epithelial barriers when exposed to an acid solution. Two in vivo models of erosive gastropathy further highlighted its topical protection against ethanol- and drug-induced mucosal injury. Overall, our findings sustain the feasibility of a paradigm shift in therapeutics R&D by depicting a very innovative and desirable mode of interaction with the human body based on the emerging biophysical, rather than the pharmacological properties of these therapeutic agents.

Indexed as

DyspepsiaGastroesophageal RefluxAnimalsGastric MucosaHumansMiceOmeprazoleOmeprazolebiophysical propertiesdyspepsiaemerging propertiesgastroesophageal reflux diseasemedical deviceNeoBianacidnon-pharmacological mechanismnovel R&D paradigmPoliprotect

Identifiers

PMID39940951
PMCPMC11818618

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.