Functional dyspepsia Digestive System
Conditions
Interventions
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 Asperg
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 t
Sponsors
Istituto Nazionale Biostrutture e Biosistemi
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Aged 59 years 2. Have a medical history or condition that could affect the subject's safety or negatively impact the validity of the study results 3. Pregnant or breastfeeding women 4. Cognitive impairments which could hinder the response to questionnaires 5. History of allergy to ingredients contained in the study treatments (dietary supplement and placebo) 6. Using drugs that could interfere with gastrointestinal motility, except those used in the treatment of functional dyspepsia itself (drug intake has been recorded) 7. Other pathologies of the gastrointestinal system (gastroesophageal reflux, irritable bowel syndrome [IBS], small intestinal bacterial overgrowth [SIBO]) 8. Malabsorption 9. History of addiction or abuse of medications or drugs 10. Continued to abuse alcohol over time (alcoholics), smokers or ex-smokers who have quit less than a year ago 11. Celiac disease 12. Eating disorders 13. Heart disease 14. Chronic hepatic, biliary and pancreatic pathologies, neoplastic pathologies, genetic-metabolic diseases or diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional dyspepsia symptoms measured using the Nepean Dyspepsia Index-SF (NDI-SF) at baseline (t0), 30 days (t1), 60 days of treatment (t2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Index (PSQI) at baseline (t0), 30 days (t1), 60 days of treatment (t2) | — |
Countries
Italy
Contacts
Public ContactAlessandra Baldi
Outcome results
None listed