Protocol summary

Study aim
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.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
All individuals receive a daily dose of either a postbiotic or placebo capsule after breakfast for 12 weeks.
Main outcome variables
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

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100119003106N46
Registration date: 2024-04-02, 1403/01/14
Registration timing: registered_while_recruiting

Last update: 2024-04-02, 1403/01/14
Update count: 0
Registration date
2024-04-02, 1403/01/14
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-10, 1402/12/20
Expected recruitment end date
2024-07-10, 1403/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
It Is 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-Beta and Interleukin 6 ; Impact on Upper Respiratory Tract Infection Incidence
Public title
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 6 ; Impact on Upper Respiratory Tract Infection Incidence.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adult men and women aged between 18 and 65 years who have a thorough comprehension of the potential risks and benefits. They are required to sign informed consent forms before participating.
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 flulike symptoms Severe diseases such as asthma and severe allergies Pregnancy, breastfeeding Drug or alcohol addiction Taking any immunosuppressants or immunomodulators
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
More than 1 sample in each individual
Number of samples in each individual: 2
From each participant, blood samples are taken twice: once at the beginning of the study and once after 12 weeks.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using random number generator software. In this way, each participant is assigned a number. People who have received an even number will receive code A, and those who have an odd number will receive code B.
Blinding (investigator's opinion)
Triple blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, Tehran Medical Branch
Street address
No.99 Yakhchal Street, Shariati Avenue, 1941933111, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2024-01-17, 1402/10/27
Ethics committee reference number
IR.IAU.TMU.REC.1402.232

Health conditions studied

1

Description of health condition studied
The effect of postbiotic supplementation on upper respiratory tract infection with a focus on beta interferon and interleukin 6.
ICD-10 code
J06.9
ICD-10 code description
Acute upper respiratory infection, unspecifiedUpper respiratory:disease, acuteinfection NOS

Primary outcomes

1

Description
Assessment of the health of the upper respiratory system
Timepoint
Every day
Method of measurement
Wisconsin Upper Respiratory Symptom Survey (WURSS)

2

Description
Complete blood count
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
Blood sample analysis

3

Description
Band cells
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
Blood sample analysis

4

Description
Neutrophil-to-lymphocyte ratio (NLR)
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
Blood sample analysis

5

Description
High-sensitivity C-reactive protein (hs-CRP)
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
Blood sample analysis

6

Description
Erythrocyte sedimentation rate (ESR)
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
Blood sample analysis

7

Description
Serum ferritin
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
Blood sample analysis

8

Description
Plasmacytoid dendritic cells (CD 86, HLD-DR)
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
Flow cytometry

9

Description
Interferon Beta
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
ELISA

10

Description
Interleukin-6
Timepoint
At the beginning of the study and after 12 weeks
Method of measurement
ELISA

Secondary outcomes

1

Description
Quality of life assessment
Timepoint
Weekly
Method of measurement
Quality of life questionnaire (SF-36)

Intervention groups

1

Description
Intervention group: All individuals receive a capsule of postbiotic that is prescribed after breakfast for a duration of 12 weeks.
Category
Prevention

2

Description
Control group: All individuals receive a capsule of placebo that is prescribed after breakfast for a duration of 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Tehran Medical Branch
Full name of responsible person
Dr. Farshad Hashemian
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
hashemian.f@iaups.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Masoud Parsania
Street address
No. 99, Yakhchal Street, Shariati Avenue.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
Masoud_parsania@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nazanin Zahra Behboodi
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Kerman street
City
Tehran
Province
Tehran
Postal code
۱۶۳۴۶۴۹۱۸۳
Phone
+98 21 2631 5739
Email
Nazaninbehboodii@icloud.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Position
professor/clinical pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
99 yasaman, Yakhchal St, Shariati Av.
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 9802122640056
Fax
+98 21 8857 7961
Email
hashemian.f@iaups.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nazanin Zahra Behboodi
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Kerman street
City
Tehran
Province
Tehran
Postal code
۱۶۳۴۶۴۹۱۸۳
Phone
+98 21 2631 5739
Email
Nazaninbehboodii@icloud.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It is 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-Beta and Interleukin 6 ; Impact on Upper Respiratory Tract Infection Incidence
When the data will become available and for how long
Immediately after publication
To whom data/document is available
For all researchers
Under which criteria data/document could be used
There is no further information.
From where data/document is obtainable
There is no further information.
What processes are involved for a request to access data/document
There is no further information.
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