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The effectiveness of two types of probiotics (lactobacillusRhamnosus and Lactobacillus Reuteri ) on the pulmonary function test of moderate asthmatic patients aged 10 – 18 years.

Protocol summary

Study aim
Determination and between-groups comparison of the mean FEV1, FVC, FEV1 / FVC, PEF, IL13, blood eosinophil percentage, and mean baseline asthma test (pre-test) • Determination and between-groups comparison of the mean FEV1, FVC, and other variables at post-test. • Determination and within-group comparison of the mean FEV1, FVC, and other variables in the study groups.
Design
Randomized clinical trial with control group, single-blind and parallel groups, phase 3 with 120 patients
Settings and conduct
120 eligible patients who will be referred to Shahid Mofteh Yasuj Children's Clinic will be examined. In the baseline, the dependent variables will be examined in the study groups and, after the intervention, the outcome variables will be measured again and compared in the groups.
Participants/Inclusion and exclusion criteria
Patients aged 10 - 18 years A well-known case of persistent moderate asthma All patients are taking fluticasone spray. No history of other respiratory illnesses Exclusion : • Immigration or death • Dissatisfaction with continuing the treatment. • In case of other infectious or chronic diseases during the research
Intervention groups
Intervention group 1. Lactobacillus Rhamnosus will be given 10 drops of this probiotic. Intervention group 2. Lactobacillus Ruteri 5 drops will be given daily and orally. Intervention group 3. The combined group will be given 10 drops of Lactobacillus Rhamnosus along with 5 drops of Lactobacillus Ruteri orally. Control group: For the control group, in the same color and similar glasses containing distilled water and orange essential oil, 10 and 5 drops will be given orally and daily.
Main outcome variables
Reduce asthma attacks, improving spirometry parameters

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220329054368N1
Registration date: 2022-05-21, 1401/02/31
Registration timing: prospective

Last update: 2022-05-21, 1401/02/31
Update count: 0
Registration date
2022-05-21, 1401/02/31
Registrant information
Name
Farnaz sadat Javanmardi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3229 8671
Email address
farnaz.javanmardi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of two types of probiotics (lactobacillusRhamnosus and Lactobacillus Reuteri ) on the pulmonary function test of moderate asthmatic patients aged 10 – 18 years.
Public title
The effectiveness of probiotics on asthmatic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 10 - 18 years A well-known case of persistent moderate asthma that has just been diagnosed and, has a medical record and approval from an asthma and allergy specialist. All patients are taking fluticasone spray. Have no history of other respiratory illnesses including interstitial pneumonia, cystic fibrosis, sickle cell disease, and primary ciliary dyskinesia
Exclusion criteria:
Immigration or death of the patient. Patient dissatisfaction in continuing the treatment. In case of other infectious or chronic diseases during the research period.
Age
From 10 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a random block method. The size of the blocks is chosen randomly (for example, blocks 4, 8, and 12) in which there is an equal number of each group in each block.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are unaware of their group and medications (drugs or placebo).
Placebo
Used
Assignment
Parallel
Other design features
According to our knowledge, the present study is the first clinical trial study in Iran on the effect of probiotics in asthmatic patients.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Science
Street address
Eram Street, Alley NO.8
City
Shiraz
Province
Fars
Postal code
7143838466
Approval date
2022-03-30, 1401/01/10
Ethics committee reference number
IR.YUMS.REC.1400.038

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45.3
ICD-10 code description
Mild persistent asthma

Primary outcomes

1

Description
Degree of asthma control, interleukin 13, blood eosinophil percentage, forced expiratory volume, peak expiratory flow, forced vital capacity
Timepoint
At the beginning of the study and two months after the intervention.
Method of measurement
Asthma control test(ACT), spirometry, CBC diff, IL13 human kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Lactobacillus rhamnosus probiotic group. The amount of 10 drops of this probiotic will be given daily and orally with the dropper.
Category
Treatment - Drugs

2

Description
Intervention group 2: Lactobacillus Rutri probiotic group. 5 drops will be given daily and orally.
Category
Treatment - Drugs

3

Description
Intervention group 3: Combination of Lactobacillus Rhamnosus and Lactobacillus Ruteri.10 drops of Lactobacillus Rhamnosus with 5 drops of Lactobacillus Ruteri will be given orally.
Category
Treatment - Drugs

4

Description
Control group: Placebo group.In glasses of the same color and similar to Lactobacillus Rhamnosus containing distilled water and orange essential oil, 10 drops will be given orally and daily.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mofteh Yasuj Children's Clinic
Full name of responsible person
Dr. Ali Fazel
Street address
Golestan NO.15, Pasdaran street.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
0743323515
Phone
+98 74 1222 3299
Fax
+98 74 3323 5153
Email
farnaz.javanmardi@yums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Amir Ghanbari
Street address
School of Medicine, Campus of University of Medical Sciences, Next to Imam Sajjad Hospital, Shahid Dr. Ghorban Ali Jalil St
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
0743323515
Phone
+98 74 3323 0290
Email
farnaz.javanmardi@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Faradaru company
Proportion provided by this source
50
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
Yasouj University of Medical Sciences
Full name of responsible person
Farnaz Sadat Javanmardi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Alley No. 8, Eram street
City
Shiraz
Province
Fars
Postal code
7143838466
Phone
+98 71 3229 8671
Fax
Email
farnaz.javanmardi@yums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Farnaz Sadat Javanmardi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Alley No. 8, Eram street
City
Shiraz
Province
Fars
Postal code
7143838466
Phone
+98 71 3229 8671
Fax
Email
farnaz.javanmardi@yums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Farnaz sadat Javanmardi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Alley No. 8, Eram street
City
Shiraz
Province
Fars
Postal code
7143838466
Phone
+98 71 3229 8671
Fax
Email
farnaz.javanmardi@yums.ac.ir

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
Only data can be shared without patient names.
When the data will become available and for how long
6 months after the publication of the article.
To whom data/document is available
Researchers
Under which criteria data/document could be used
Sharing results to improve children's health.
From where data/document is obtainable
FarnazSadat Javanmardi
What processes are involved for a request to access data/document
Formal request to be sent via email.
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