Evidence map›Paper›PMID 32210642›Full record

ArticleMedical devices (Auckland, N.Z.)2020

Evaluation of Human Esophageal Epithelium Permeability in Presence of Different Formulations Containing Hyaluronic Acid and Chondroitin Sulphate.

Gaia Pellegatta, Marco Spadaccini, Laura Lamonaca, Vincenzo Craviotto, Ferdinando D'Amico, Laura Ceriotti, Marisa Meloni, Alessandro Repici

Abstract read
In one paragraph

Article in Medical devices (Auckland, N.Z.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Safety and efficacy of substance-based medical devices: Design of anFrontiers in drug safety and regulation · 2023
    Article
  5. Article
  6. 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

8 authors.

Gaia PellegattaHumanitas Clinical and Research Center and Humanitas University, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, MI, Italy.
Marco SpadacciniHumanitas Clinical and Research Center and Humanitas University, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, MI, Italy.
Laura LamonacaHumanitas Clinical and Research Center and Humanitas University, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, MI, Italy.
Vincenzo CraviottoHumanitas Clinical and Research Center and Humanitas University, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, MI, Italy.
Ferdinando D'AmicoHumanitas Clinical and Research Center and Humanitas University, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, MI, Italy.
Laura CeriottiVitroScreen, Milano, Italy.
Marisa MeloniVitroScreen, Milano, Italy.ORCID 0000-0001-6170-1001
Alessandro RepiciHumanitas Clinical and Research Center and Humanitas University, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, MI, Italy.ORCID 0000-0002-1621-6450

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeNew medical devices that contain hyaluronic acid (HA) and chondroitin sulphate (CS), with or without antacid components, have been developed for the treatment of gastroesophageal reflux disease (GERD) with the aim of improving oesophageal mucosal defences by creating a film on the oesophageal mucosa and acting as a mechanical barrier against the noxious components of refluxate, both acidic and basic.

methodsThe film-forming and protective efficacy of medical device A based on HA and CS plus aluminium hydroxide, device B combining HA and CS with magnesium trisilicate and device C with only the combination of HA and CS was tested on a reconstructed human oesophageal epithelium (HO2E/S/5) as a biological model in 2 different pH environments, neutral and acidic, to mimic realistic conditions. Caffeine penetration kinetics and Lucifer yellow (LY) permeability modifications induced by these products were compared to those induced by a negative control series (saline solution, code NC) and positive control series (white Vaseline, code V) under neutral and acidic pH conditions.

resultsUnder neutral and acidic pH conditions, compared to the negative control, all the products tested reduced (>80% and 85-90%, respectively) the caffeine passage, and no significant difference was observed among the products tested. Under neutral and acidic conditions, the LY permeabilities registered with device A and device C were not different from that registered with the negative control, while an LY flux% increase was calculated after 2 hrs of treatment (21.1%) with device B under acidic conditions.

conclusionThese results confirm the ability of the products tested to interact with the oesophageal epithelium in order to adhere and create a stable protective film for at least 2 hours after their homogeneous distribution on the epithelium surface. Further clinical studies are needed to test these devices in the topical treatment of gastroesophageal reflux symptoms.

Indexed as

antacidcaffeinechondroitin sulphategastroesophageal reflux diseasehyaluronic acidLucifer yellow

Identifiers

PMID32210642
PMCPMC7069498

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Registered trials

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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 OpenQuestion graph.