Assessment of the Effects of Postbiotic Supplementation with Lactobacillus rhamnosus CRL 1505 and Lactobacillus johnsonii La1 (La1), with a Focus on Interleukin 10 ; Impact on Upper Respiratory Tract Infection and vaginitis Incidence.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100119003106N48

Enrollment

150

Registered

2024-04-04

Start date

2024-04-20

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: upper respiratory tract infection. Condition 2: vaginitis. Acute upper respiratory infection, unspecified Acute vaginitis

Interventions

Intervention 1: Intervention group: All individuals receive a capsule of postbiotic that is prescribed one hour before or after breakfast for a duration of 12 weeks. Intervention 2: Control group: All

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: adult men or women between 18 and 65 years old who enter the study and have fully understood the risks and potential benefits of participating in the study and before entering the study, consent forms They have signed it knowingly.

Exclusion criteria

Exclusion criteria: Unwillingness to continue or participate in the study Diagnosis of immunodeficiency due to any diagnosed chronic disease Gastrointestinal ulcer Liver and kidney dysfunction Human immunodeficiency virus Autoimmune disorders Malignancy, or any history of malignancy Any diagnosis of respiratory diseases with cold or flu-like symptoms Severe diseases such as asthma and severe allergies Pregnancy, breastfeeding Drug or alcohol addiction Taking any immunosuppressants or immunomodulators

Design outcomes

Primary

Measure	Time frame
Assessment of the health of the upper respiratory system. Timepoint: Every day. Method of measurement: Wisconsin Upper Respiratory Symptom Survey (WURSS).;Complete blood count. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;Band cells. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;Neutrophil-to-lymphocyte ratio (NLR). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;High-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;Erythrocyte sedimentation rate (ESR). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;Serum ferritin. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;Plasmacytoid dendritic cells (CD 86, HLD-DR). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Flow cytometry.;Interleukin-10. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: ELISA.	—

Measure

Time frame

Assessment of the health of the upper respiratory system. Timepoint: Every day. Method of measurement: Wisconsin Upper Respiratory Symptom Survey (WURSS).;Complete blood count. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;Band cells. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;Neutrophil-to-lymphocyte ratio (NLR). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;High-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;Erythrocyte sedimentation rate (ESR). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;Serum ferritin. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;Plasmacytoid dendritic cells (CD 86, HLD-DR). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Flow cytometry.;Interleukin-10. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: ELISA.

—

Secondary

Measure	Time frame
Quality of life assessment. Timepoint: Weekly. Method of measurement: Quality of life questionnaire (SF-36).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSooroor Halvaei

Islamic Azad University

Shakilahalvaei@gmail.com+98 21 2260 0037

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026