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

Not Applicable

Completed

• Conditions: Functional dyspepsia; Digestive System

• Registration Number: ISRCTN67691215
• Lead Sponsor: Istituto Nazionale Biostrutture e Biosistemi

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37976892/ (added 29/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-28
• Study Completion: 2023-09-01
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

1. Aged <18 and >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified