Immune modulation and quality of life in healthy adults. Other
Conditions
Interventions
Participants are randomly assigned (1:1) to receive either the probiotic product or a placebo for 90 days. The experimental group receives one oral capsule daily before meals containing Bacillus coagu
Sponsors
Nutris We Care About You
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female volunteers aged 18–65 years 2. Individuals following a balanced diet according to standard nutritional guidelines 3. Participants performing at least 30 minutes of daily physical activity 4. Good personal hygiene and general health status 5. No psychological or psychiatric disorders 6. No family history of genetically heritable diseases 7. Able to understand the study information and comply with study requirements 8. Willing to provide written informed consent before participation
Exclusion criteria
Exclusion criteria: 1. Diagnosis of diabetes mellitus 2. Pregnant or breastfeeding women 3. Presence of autoimmune disease (e.g. Addison’s disease, celiac disease, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, type I diabetes, etc.) 4. Current or recent treatment with immunosuppressive drugs 5. Presence of any chronic disease or acute respiratory infection (including common cold, flu, or COVID-19). 6. Use of antibiotics within 10 days prior to study start 7. Intake of probiotics or immune-boosting supplements (e.g. vitamin C, echinacea, royal jelly, multivitamins) within 10 days prior to study start 8. History of drug, alcohol, or substance abuse 9. Participation in another clinical trial within the previous 3 months 10. Any medical or social condition that, in the investigator’s opinion, could interfere with study participation or data reliability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of immunological markers (immunoglobulin A [IgA], immunoglobulin G [IgG], interferon-? [IFN-?], and total leukocyte count) measured by blood analysis at baseline (Day 1) and after 90 days of supplementation (Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life measured using the SF-36 questionnaire at baseline (Day 1) and after 90 days of supplementation (Day 90) 2. Safety and tolerability assessed through participant reports and clinical evaluation at each visit and via follow-up phone call (around Day 45) | — |
Countries
Spain
Contacts
Public ContactVeronica Gallo
Outcome results
None listed