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Article

E-Gastryal® + Magnesium Alginate Plus PPI vs. PPI Alone in GERD: Results from the GENYAL® Randomized Controlled Trial

by
Cristiano Spada
1,2,
Daniele Salvi
3,*,
Silvia Pecere
1,2,
Francesca Mangiola
1,2,
Simone Varca
1,2,
Serban Rosu
4,
Vora Prateek
5,
Petru Vasile Ciobanca
6,
Adrian Goldis
7,
Dionisio Franco Barattini
8 and
Guido Costamagna
1,2
1
Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy
2
Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, 00168 Rome, Italy
3
Department of Gastroenterology and Endoscopy, Fondazione Poliambulanza Istituto Ospedaliero, 25124 Brescia, Italy
4
University of Medicine and Pharmacy Victor Babes, Piața Eftimie Murgu 2, 300041 Timisoara, Romania
5
Medlife SA, Bld. Eroilor de la Tisa 28, 300551 Timisoara, Romania
6
Centrul Medical Salvosan Ciobanca, Str. Dumbrava 48, Bloc TCI, 45051 Zalau, Romania
7
Cabinet Particular Policlinic Algomed, Str. Blaga Lucian 4, 300002 Timisoara, Romania
8
Opera CRO, a TIGERMED Group Company, Str. Cozia 10, 300209 Timisoara, Romania
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2025, 14(13), 4794; https://doi.org/10.3390/jcm14134794
Submission received: 10 May 2025 / Revised: 30 June 2025 / Accepted: 3 July 2025 / Published: 7 July 2025
(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)
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Abstract

Background: Up to one-third of patients with gastroesophageal reflux disease (GERD) have persistent symptoms despite proton-pump inhibitor (PPI) therapy. E-Gastryal® + MgAlg (Aurora Biofarma, Italy) is a mucosal protective agent that enhances barrier function against acid and non-acidic reflux. This study assessed its efficacy in combination with omeprazole versus omeprazole alone and as maintenance therapy. Methods: Patients with symptomatic GERD and Grade A reflux esophagitis confirmed by endoscopy were randomized to receive omeprazole 20 mg plus E-Gastryal® + MgAlg or omeprazole 20 mg alone. The primary endpoint was the number of rescue medications used over 28 days. Secondary endpoints included symptom relief and quality-of-life assessments using the Reflux Symptom Index (RSI), Gastroesophageal Reflux Disease Impact Scale (GIS), GERD-Health-Related Quality of Life (GERD-HRQL), and Global Assessment of Performance (IGAP). Results: Ninety-six patients were included. The combination group used significantly fewer rescue medications (mean: 21 vs. 40.9 tablets; p = 0.002). At week 4, the combination group showed greater improvement in RSI, GIS, and GERD-HRQL scores (p < 0.001). Symptom relief was sustained during weeks 5–26 with E-Gastryal® + MgAlg alone. Conclusions: E-Gastryal® + MgAlg combined with omeprazole improves symptom control compared to PPI monotherapy. Continued use as maintenance therapy supports its role in long-term GERD management (NCT04130659).
Keywords: medical device; proton-pump inhibitor; gastroesophageal reflux disease; sodium alginate; mucosal protective agent medical device; proton-pump inhibitor; gastroesophageal reflux disease; sodium alginate; mucosal protective agent

Share and Cite

MDPI and ACS Style

Spada, C.; Salvi, D.; Pecere, S.; Mangiola, F.; Varca, S.; Rosu, S.; Prateek, V.; Ciobanca, P.V.; Goldis, A.; Barattini, D.F.; et al. E-Gastryal® + Magnesium Alginate Plus PPI vs. PPI Alone in GERD: Results from the GENYAL® Randomized Controlled Trial. J. Clin. Med. 2025, 14, 4794. https://doi.org/10.3390/jcm14134794

AMA Style

Spada C, Salvi D, Pecere S, Mangiola F, Varca S, Rosu S, Prateek V, Ciobanca PV, Goldis A, Barattini DF, et al. E-Gastryal® + Magnesium Alginate Plus PPI vs. PPI Alone in GERD: Results from the GENYAL® Randomized Controlled Trial. Journal of Clinical Medicine. 2025; 14(13):4794. https://doi.org/10.3390/jcm14134794

Chicago/Turabian Style

Spada, Cristiano, Daniele Salvi, Silvia Pecere, Francesca Mangiola, Simone Varca, Serban Rosu, Vora Prateek, Petru Vasile Ciobanca, Adrian Goldis, Dionisio Franco Barattini, and et al. 2025. "E-Gastryal® + Magnesium Alginate Plus PPI vs. PPI Alone in GERD: Results from the GENYAL® Randomized Controlled Trial" Journal of Clinical Medicine 14, no. 13: 4794. https://doi.org/10.3390/jcm14134794

APA Style

Spada, C., Salvi, D., Pecere, S., Mangiola, F., Varca, S., Rosu, S., Prateek, V., Ciobanca, P. V., Goldis, A., Barattini, D. F., & Costamagna, G. (2025). E-Gastryal® + Magnesium Alginate Plus PPI vs. PPI Alone in GERD: Results from the GENYAL® Randomized Controlled Trial. Journal of Clinical Medicine, 14(13), 4794. https://doi.org/10.3390/jcm14134794

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