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

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Assessment of the Effects of Postbiotic Supplementation with Lactobacillus rhamnosus CRL 1505 and Lactobacillus acidophilus (Johnsonii) La1, with a Focus on Interferon-Gamma; Impact on Upper Respiratory Tract Infection Incidence

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100119003106N47
Enrollment
150
Registered
2024-04-03
Start date
2024-03-10
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

The Effects of Postbiotic Supplementation with Lactobacillus rhamnosus CRL 1505 and Lactobacillus acidophilus (Johnsonii) La1, with a Focus on Interferon-gamma

Interventions

Intervention 1: Intervention group: All individuals receive a once-daily dose. A capsule of postbiotic that is prescribed after breakfast for a duration of 12 weeks. Intervention 2: Control group: All

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adult men and women aged between 18 and 65 years who enter the study must have a thorough comprehension of the potential risks and benefits. They are required to sign informed consent forms before participating.

Exclusion criteria

Exclusion criteria: Reluctance to continue or participate in the study As diagnosed with decreased immunity due to any chronic illness Gastrointestinal ulcers, liver and kidney dysfunction HIV (Human Immunodeficiency Virus), autoimmune disorders, malignancies, or any history of malignancy Diagnosed respiratory illnesses with symptoms resembling cold or influenza Severe conditions such as asthma and severe allergies Pregnancy, breastfeeding Substance abuse or alcohol addiction Use of any immune-suppressing or immune-modulating agents Patients with known allergic reactions to intervention drugs

Design outcomes

Primary

MeasureTime 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 cell. 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.;Highly-sensitive 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.;Ferritin blood test. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Blood sample analysis.;Plasmacytoid dendritic cells (CD 86, HLA-DR). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Flow cytometry.;IFN-gamma. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: ELISA.

Secondary

MeasureTime frame
Quality of life. Timepoint: Weekly. Method of measurement: SF-36 Quality of life Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahshad Shabani

Islamic Azad University

mahshad.shabani@gmail.com+98 22640056

Outcome results

None listed

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