Double-Center, Randomized, Double-Blind, Placebo-Controlled Study on the Effects of Postbiotic Supplementation with Lactobacillus rhamnosus CRL 1505 and Lactobacillus johnsonii La1 (La1), with a Focus on IL-10; Impact on Upper Respiratory Tract Infection and Vaginitis Incidence

Evaluate the impact of each of the postbiotic supplements, Lactobacillus rhamnosus CRL 1505 heat-killed and Lactobacillus johnsonii La1 (La1), on reducing upper respiratory tract infection and vaginitis, considering changes in the blood level of IL10,during a 12-week intervention period.

Present study is a multi-center, randomized, double-blind, placebo-controlled trial with a 12-week postbiotic intervention. All postbiotic products, except for the tested formulation, are prohibited throughout the study.

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 johnsonii La1 (La1)) and one placebo group. Random selection of participants is done using software.

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.

All subjects receive a once-daily dose. One postbiotic or placebo capsule is administered one hour before or after breakfast for 12 weeks.

* Evaluation of upper respiratory symptoms using the Wisconsin Upper Respiratory Symptom Survey (WURSS) *Blood Analysis *Quality of life assessment using quality of life questionnaire (SF-36)

Two groups of cans were prepared, in one group, postbiotic pills and in the other group, a placebo in the amount necessary for the patients to consume for three months. The cans have a label containing post-biotic / placebo, drug code, expiration date, and instructions for use, and their coding was done by a third person who was not involved in the study. She noted the codes in the table and decoded them at the end of the study. The cans containing medicine and placebo were similar in every respect and could not be distinguished by the participants, the main researcher, the attending physician, the data collector and the data analyst. Therefore, all the mentioned people were blinded to the studied groups

Two groups of cans were prepared (A & B coded), in one group, postbiotic pills and in the other group, a placebo in the amount necessary for the patients to consume for three months. The cans have a label containing post-biotic / placebo, drug code, expiration date, and instructions for use, and their coding was done by a third person who was not involved in the study. She noted the codes in the table and decoded them at the end of the study. The cans containing medicine and placebo were similar in every respect and could not be distinguished by the participants, the main researcher, the attending physician, the data collector and the data analyst. Therefore, all the mentioned people were blinded to the studied groups.

All data can potentially be shared after de-identifying individuals.

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