Efficacy and safety of a new food supplement in the treatment of functional dyspepsia. An open study

Introduction: Current treatments for functional dyspepsia (FD) are based on neutralizing gastric acidity, which plays an important role in food digestion and sterilization. Hence, the risk of negative consequences, such cognitive decline. The aim of the study was to assess the ability of a novel food supplement based on hydrolyzed collagen and tricalcium phosphate to ameliorate FD symptoms. It mainly acts on the physical protection of the gastric mucosa, without blocking acidity. Methods: 22 patients with Rome IV criteria FD were recruited. All subjects were neither pregnant nor breastfeeding. They had a normal upper endoscopy prior to enrolment, with no current use or history of antacid, antisecretory, prokinetic, antidepressant and anxiolytic use. Individuals with kidney, biliary and pancreatic diseases were excluded. Patients were advised to take 1 tablet thrice a day of the food supplement. Gastrointestinal symptoms were measured by the Gastrointestinal Rating Scale (GSRS) questionnaire before and after 28-days of therapy. Adverse effects were monitored during and after the treatment. Results: Compared to baseline, a significant total score reduction (p = 0.0062) was recorded. GSRS total score at baseline was 27.9 ± 15.2, against 17.3 ± 13.6 at the end of the study, showing a decrease of -10.6 ± 11.6. The main symptoms that decreased were abdominal pain (-1.7 ± 1.6 p-value <0.0001), heartburn (-1.1 ± 1.8 p-value 0.0132), nausea (-1 ± 1.7 p-value 0.0142) and eructation (-0.9 ± 1.6 p-value 0.0161). Less significant changes were recorded concerning borborygmus (-0.2± 1.5 p-value 0.5757) constipation (-0.2± 1.3 p-value 0.4238) and troublesome solid stools (-0.1 ± 1.8 p-value 0.7269). The nutritional supplement was found to be safe and well tolerated during the study. Conclusion: Dyspeptic symptoms were reduced in all patients, demonstrating the effectiveness and safety of the nutritional supplement, as shown by FD symptoms improvement.