Clinical study to investigate the efficacy of formulations containing prebiotics and probiotics on the intestinal microbiota and on the immune system of elderly subjects

Complife Italia Srl0 个研究点目标入组 75 人开始时间: 2020年2月7日最近更新: 2023年4月10日

适应症

试验速览

•1. Aged from 60 to 80 years on the day of inclusion
•2. Ability to comply with all the trial procedures
•3. Received an influenza vaccine more than 12 months prior to enrolment
•4. Body Mass Index (BMI) between 18.5 and 24.99
•5. Willingness to not vary the daily diet, fluid intake, and exercise routine during the trial period
•6. Willingness to follow the proposed alimentary supplement for the trial period
•7. Willingness to use only the supplement being tested during the trial period
•8. Willingness to not use products likely to interfere with the product to be tested
•9. Informed consent is given

•1. Contraindications to the influenza vaccine
•2. Immune system modulation treatment received within 4 weeks of the trial period
•3. Immunosuppressant therapy lasting more than 2 weeks or stopped less than 3 months prior to the trial period
•4. Influenza vaccination within one year of the trial period
•5. Current antibiotic treatment
•6. Known history of a chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency
•7. Treatment with probiotics within 6 months of the trial period
•8. Severe concurrent disease
•9. Drug abuse
•10. Alcohol abuse
•11. Use of fiber products within 6 weeks of the trial period
•12. Normal dietary intake exceptionally high in plant-based, high-fiber foods (fruits, vegetables, beans, whole grains, fortified foods), including those following a strict vegetarian diet
•13. Dietary intake of probiotics
•14. Pre-existing hypersensitivity to components contained in the probiotic
•15. Any condition that the principal investigator deems inappropriate for participation
•16. Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated).
•17. Subjects who have been recently involved in any other similar study

发起方