MATTEO INNOCENTI1*, ROMANO SILVESTRI2, MAURIZIO CERACCHI3, BRUNO SILVESTRINI4
*Corresponding author
1. Department of Drug Chemistry and Technologies, Sapienza University of Rome, Rome, Italy
2. Laboratory affiliated with the Institute Pasteur Italy and Cenci Bolognetti Foundation,
Department of Drug Chemistry and Technologies, Sapienza University of Rome, Rome, Italy
3. CMV-Stat Statistician, Rome, Italy
4. Fondazione di Noopolis, Rome, Italy

Abstract

Current treatments for functional dyspepsia (FD) are based on neutralizing gastric acidity, which favors food digestion and sterilization. Hence, the risk of negative consequences. This study was aimed at assessing the ability of a food supplement, based on hydrolyzed collagen and tricalcium phosphate, to ameliorate FD symptoms.
Methods: 22 patients were recruited according to the Rome IV criteria. Subjects were neither pregnant nor breastfeeding. They had a normal upper endoscopy prior to enrolment, with no current of antacid, antisecretory, prokinetic, antidepressant and anxiolytic use. Individuals with kidney, biliary and pancreatic diseases were excluded.
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. The main symptoms that decreased were abdominal pain and eructation (-0.9 ± 1.6 p-value 0.0161). The nutritional supplement was found to be safe and well tolerated.
Conclusion: Dyspeptic symptoms were reduced in all patients, representing the effectiveness and safety of the nutritional supplement.

INTRODUCTION
Dyspepsia refers to chronic or recurrent pain in the upper abdominal region, associated with heartburn, bloating, belching, nausea, gastro esophageal reflux (1-3). Dyspepsia is a public health issue due to the high prevalence and chronic or recurrent symptomatology, which affects quality of life.

All forms of dyspepsia have in common two factors: an excessive secretion of hydrochloric acid by parietal cells and a reduction of the mucus that covers and protects the internal surface of the stomach. Ulcerative forms from non-steroidal anti-inflammatory drugs (NSAIDs) are a typical example of the second factor. Rather than increasing the acid secretion (4), they depress the prostaglandin-related mucus secretion in the stomach (5). Hence, a risk of low acidity dyspepsia, eventually associated with ulcers, perforations and gastrointestinal bleeding (6-11).

Organic causes of dyspepsia include Helicobacter pylori infection, peptic ulcer, esophagitis, or cancer. Less likely causes are pancreatic or hepatobiliary diseases and duodenal micro-inflammation (12).

Approximately 80% of patients wi ...