A selected probiotic formula to reduce flu-related symptoms in vaccinated elderly people

Not Applicable

Completed

• Conditions: Influenza, common infectious disease symptoms in flu-vaccinated elderly subjects; Respiratory

• Registration Number: ISRCTN93895684
• Lead Sponsor: Complife Italia Srl

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-05-13
• Study Start: 2020-11-12
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified