A multistrain probiotic formulation to enhance resistance to common infectious diseases in flu-vaccinated health free-living elderly subjects, modulating gut microbiota diversity

Complife Italia Srl0 个研究点目标入组 75 人开始时间: 2020年11月12日最近更新: 2022年9月5日

适应症

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35744774/ (added 24/08/2022)

•1. Aged between 60 and 80 years on the day of inclusion
•2. Able to comply with all the trial procedures
•3. Inoculated with an influenza vaccine
•4. Body Mass Index (BMI) between 18.5 and 24.99
•5. Willing to not vary the normal daily routine (such as lifestyle and physical activity)
•6. Willing to not alter their usual diet or fluid intake during the trial periods
•7. Willing to follow the proposed alimentary supplement for all the study time
•8. Willing to use during all the study period only the product to be tested
•9. Willing to not use products likely to interfere with the product to be tested
•10. Aware of the study procedures and signed an informed consent form

•1. Recently involved in any other similar study
•2. Contraindications to influenza vaccinations
•3. Undergoing treatment related to immune system modulation in the past 4 weeks
•4. Therapy for immunosuppressants for >2 weeks, either currently or stopped <3 months before inclusion
•5. Received an influenza vaccination <1 year before inclusion
•6. Current antibiotic treatment
•7. History of chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency
•8. Probiotic treatment within the 6 months before enrollment
•9. Severe concurrent diseases
•10. Drug abuse and/or alcohol abuse
•11. Use of fiber products within the last 6 weeks
•12. Dietary intake exceptionally high in plant-based, high fiber foods (such as fruits, vegetables, beans, whole grains, and 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)

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