Poliprotect vs Omeprazole in the Relief of Heartburn, Epigastric Pain, and Burning in Patients Without Erosive Esophagitis and Gastroduodenal Lesions: A Randomized, Controlled Trial.

"CONFLICTS OF INTEREST Guarantor of the article: Enrico Stefano Corazziari, MD. Specific author contributions: E.S.C.: contributed for conceptualization, literature search, figures, study design, data collection, data analysis, writing first draft, and had access and verified data. A.G., L.D.'A., V.D.'O., O.R., S.P., B.A., M.C., A.R., G.B., C.C., A.D.S., M.N., M.C.B., E.R., P.I., and D.B.: contributed equally for resources, investigation, data collection, writing-review & editing. G.R., M.M., S.S.: contributed for microbiota analysis and interpretation, writing & editing. Financial support: This study received funding from Aboca S.p.A., the manufacturer of the medical device (i.e., the test product; brand name: neoBianacid). The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Potential competing interests: E.S.C. and B.A.: perform consultancies for Aboca S.p.A. Study HighlightsWHAT IS KNOWN✓ Mucosal protective agents (MPA) are widely used in the treatment of gastroesophageal reflux and functional dyspepsia but no study has so far compared their effectiveness with the reference standard Proton Pump Inhibitors (PPI) for these conditions.WHAT IS NEW HERE✓ The results of this RCT indicate that Poliprotect, an MPA made of natural substances, could be a valuable alternative to PPI in the treatment of heartburn, epigastric pain and burning in NonErosive Reflux Disease (NERD) and Epigastric Pain Syndrome (EPS) patients.✓ Of clinical interest is also the evidence that NERD and EPS patients are not clinically distinguishable and benefit from the same treatment."

"Financial support: This study received funding from Aboca S.p.A., the manufacturer of the medical device (i.e., the test product; brand name: neoBianacid). The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report."

"DISCUSSION:: Poliprotect proved noninferior to standard-dose omeprazole in symptomatic patients with heartburn/epigastric burning without erosive esophagitis and gastroduodenal lesions. Gut microbiota was not affected by Poliprotect treatment. The study is registered in Clinicaltrial.gov (NCT03238534) and the EudraCT database (2015-005216-15)."