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Study aim
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Evaluate the impact of each of the postbiotic supplements, Lactobacillus rhamnosus CRL 1505 heat-killed and Lactobacillus acidophilus (Johnsonii) LA1, on reducing upper respiratory tract infections, considering changes in the blood level of Interferon-Beta and Interleukin 6, among healthy adults aged 18 to 65 during a 12-week intervention period.
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Design
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This study is a multi-center, randomized, double-blind, placebo-controlled trial with a 12-week postbiotic intervention. All postbiotic products, except for the studied formulation, are prohibited throughout the study.
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Settings and conduct
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In each group, 150 participants are randomly assigned to receive either postbiotics or placebos for 12 weeks. The study includes two probiotic groups (Lactobacillus rhamnosus CRL 1505 and Lactobacillus acidophilus (Johnsonii) La1) and one placebo group. Random selection of participants is done using software.
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Participants/Inclusion and exclusion criteria
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Eligible participants: Adults aged 18-65 providing informed consent. Discontinuation criteria: Unwillingness, withdrawal of consent, diagnosed immunodeficiency, gastrointestinal ulcers, liver/kidney dysfunction, HIV, autoimmune disorders/malignancies, respiratory illnesses resembling cold/flu, severe conditions (asthma/allergies), pregnancy/substance abuse, breastfeeding, use of immune-suppressing agents, or known allergies to intervention drugs.
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Intervention groups
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All individuals receive a daily dose of either a postbiotic or placebo capsule after breakfast for 12 weeks.
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Main outcome variables
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Questionnaire: Evaluation of upper respiratory symptoms using the Wisconsin Upper Respiratory Symptom Survey (WURSS), a disease-specific quality of life assessment tool designed to assess the negative impact of acute upper respiratory tract infections. Blood sample Analysis Weekly Questionnaire