Poliprotect vs Omeprazole in the relief of heartburn, epigastric pain and burning in patients without erosive esophagitis and gastro-duodenal lesions: A Randomized, Controlled Trial

Background: In the treatment of upper GI endoscopy-negative patients with heartburn and epigastric pain or burning, antacids, anti-reflux agents, and mucosal protective agents (MPA) are widely used, alone or as add-on treatment to increase response to proton pump inhibitors, which are not indicated in infancy and pregnancy, and account for significant cost expenditure. Aims methods: In this randomized, controlled, double-blind, double-dummy, multicenter trial assessing the efficacy and safety of MPA Poliprotect (neoBianacid®) versus Omeprazole in the relief of heartburn and epigastric pain/burning, 275 endoscopy-negative outpatients were given a 4-week treatment with Omeprazole (20 mg q.d.) or Poliprotect (5 times a day for the initial 2 weeks, and on-demand thereafter), followed by an open-label 4-week treatment period with Poliprotect on demand. Gut microbiota change was assessed. Results: A 2-week treatment with Poliprotect proved non-inferior to Omeprazole for symptom relief (between-group difference in the change in VAS symptom score: [mean, 95% CI] -5.4, -9.9 to -0.1; -6.2, -10.8 to -1.6; ITT and PP populations, respectively).Poliprotect's benefit remained unaltered after shifting to on-demand intake, with no gut microbiota variation. The initial benefit of Omeprazole was maintained against significantly higher use of rescue medicine sachets (mean, 95% CI: Poliprotect 3.9, 2.8-5.0; Omeprazole 8.2, 4.8-11.6) and associated with an increased abundance of oral cavity genera in the intestinal microbiota. No relevant adverse events were reported in either treatment arm. Conclusions: Poliprotect proved non-inferior to standard-dose Omeprazole in symptomatic patients with heartburn/epigastric burning without erosive esophagitis and gastro-duodenal lesions. Gut microbiota was not affected by Poliprotect treatment. The study is registered in Clinicaltrial.gov (NCT03238534) and the EudraCT Database (2015-005216-15).