Vol. 33 | Vol. 33 (3) – 2022 | NOVEL FOOD

Efficacy and safety of a new food supplement in the treatment of functional dyspepsia: an open study

by 10 November 2022

M. Innocenti, R. Silvestri, M. Ceracchi, B. Silvestrini 10 November 2022

dyspepsia

FUNCTIONAL DYSPEPSIA

Gastrointestinal symptom rating scale

Hydrolyzed collagen

Novel food

Peer Reviewed

tricalcium phosphate

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.

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