The beneficial effect of ingestion of a food supplement based on a pool of digestive enzymes in people with functional dyspepsia

INTERVENTION: The subjects recruited in the present clinical study will consume a food supplement based on a pool of digestive enzymes derived from fungal microorganisms (amylase, protease, and lactase from Aspergillus oryzae, cellulase from Trichoderma reesei, lipase form Rhizopus oeyzae) or a placebo for 60 days based on the randomization group. The randomization sequence will be generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC) and the randomization list will be kept hidden. The participants will be assigned to each of the two treatment groups (food supplement or placebo) casually and by simple randomization (1:1 allocation ratio). The randomization code will consist of a three‐digit number as indicated in the respective Case Report Form (CRF). In the clinical study, 120 participants will be enrolled and divided into two groups (60 for each group): Group 1: food supplement containing the pool of digestive enzymes. Group 2: placebo. The supplementation consists of two capsules/day for a total dosage of 400 mg/die of the digestive enzyme pool. Participants will undergo four visits (baseline = t0; after 30 days of treatment = t1; after 60 days of treatment = t2) in an outpatient setting. After each clinical visit, all data are filled in the CRF by physicians. During the screening visit, subjects will undergo the following investigation to understand if they meet the study participation requirements: Functional dyspepsia diagnosis confirmation, using Rome IV criteria, which predict, in an individual who does not present organic causes, the occurrence of at l CONDITION: Functional dyspepsia ; Digestive System PRIMARY OUTCOME: ; Functional dyspepsia symptoms measured using the Nepean Dyspepsia Index‐SF (NDI‐SF) at baseline (t0), 30 days (t1), 60 days of treatment (t2); SECONDARY OUTCOME: ; 1. Perceived general pain measured using the Visual Analog Scale (VAS) at baseline (t0), 30 days (t1), 60 days of treatment (t2); 2. Sleep quality measured using the Pittsburgh Sleep Quality Inde X(PSQI) at baseline (t0), 30 days (t1), 60 days of treatment (t2); INCLUSION CRITERIA: 1. Aged 18‐59 years of both sexes 2. Diagnosis of functional dyspepsia according to the Rome IV criteria 3. Have not taken antibiotics or other drugs whose primary site of action is the gastrointestinal tract in the month prior to screening, except those used in the treatment of functional dyspepsia itself (drug intake has been recorded) 4. Have agreed not to significantly modify their normal eating habits during the study period 5. Not using other food supplements throughout the study period 6. Able to understand and sign the informed consent