The effect of probiotic on improvement of bacterial pneumonia in admitted patients to Shahid Beheshti hospital in Kashan
Specific goals include:
Determination of hospitalization duration, duration of dyspnea, tachypnea, cough, lung auscultation and reduction of fever in both groups.
Design
This study is a double-blind randomized clinical trial. Patients are randomly divided into case and control groups, each containing 50 patients.
Settings and conduct
Patients are randomly classified into two groups. Case group receive 2 sachets of probiotic /daily for 5 days and control group placebo. Patients in both groups receive same treatment protocol. This study is double blind randomized clinical trial. Probiotic and placebo are designed as medicinal sachets with same color and size. Numerical codes are recorded on each sachet from 1 to 100 and numbers for each group are determined using block randomization methods.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age over 12 years.
2. Early diagnosis is bacterial pneumonia.
3. Taking written consent from patients to entry the study.
4. The patient is able to eat probiotic or placebo.
5. Pneumonia is not very severe requiring admission in ICU.
Exclusion criteria:
1. No previous heart failure and pulmonary edema.
2. No underlying pulmonary disease.
3. Intolerance or allergy to probiotic.
Intervention groups
All patients with bacterial pneumonia admitted to infectious and pediatric ward of Shahid Beheshti hospital in Kashan during 2018.
Main outcome variables
The probiotic can be effective in reducing the duration of dyspnea, tachypnea, cough, fever and length of hospitalization.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200107046047N1
Registration date:2020-04-07, 1399/01/19
Registration timing:retrospective
Last update:2020-04-07, 1399/01/19
Update count:0
Registration date
2020-04-07, 1399/01/19
Registrant information
Name
Ahmad Najafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5533 0489
Email address
najafi-a@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-30, 1396/11/10
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
2018-01-30, 1396/11/10
Actual recruitment end date
2018-04-19, 1397/01/30
Trial completion date
2018-04-24, 1397/02/04
Scientific title
The effect of probiotic on improvement of pneumonia
Public title
Probiotic in treatment of pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 12 years.
Bacterial pneumonia is early diagnosis.
Taking written consent from the patient to participate in the study.
The patient is able to eat probiotic or placebo.
Pneumonia is not very severe requiring admission in ICU.
Exclusion criteria:
The patient has no previous heart failure and pulmonary edema.
No underlying pulmonary disease.
Intolerance or allergy to probiotic.
Dissatisfaction of patients for participating in study.
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
We divide each referral into two groups using a randomized table. This table is a collection of number. Consider numbers from 1 to 50 for intervention and numbers 51 to 100 for control . The lets move on one of the numbers and move in one of the preset directions and assign the numbers to one of the groups.Thus patients are completely randomly divided.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, principal investigator, clinical caregivers
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Third floor, Zagros building, Baran street, Shohada fin bozorg bulvard, Amerieh square, Amir Kabir street
City
Kashan
Province
Isfehan
Postal code
8718615699
Approval date
2018-01-29, 1396/11/09
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.101
Health conditions studied
1
Description of health condition studied
Bacterial pneumonia
ICD-10 code
J15
ICD-10 code description
Bacterial pneumonia, not elsewhere classified
Primary outcomes
1
Description
Duration of hospitalization
Timepoint
From hospitalization to discharge
Method of measurement
Number of days of hospitalization based on patient file and questionnaire
2
Description
Dyspnea duration
Timepoint
From hospitalization to discharge
Method of measurement
Completion of questionnaire and examination of patient
3
Description
Tachypnea duration
Timepoint
From hospitalization to discharge
Method of measurement
Completion of questionnaire and examination of patient
4
Description
Duration of cough
Timepoint
From hospitalization to discharge
Method of measurement
Completion of questionnaire and examination of patient
5
Description
Duration of lung auscultation rales
Timepoint
From hospitalization to discharge
Method of measurement
Patient examination and questionnaire completion
6
Description
Duration of fever
Timepoint
From hospitalization to discharge
Method of measurement
Patient examination and questionnaire completion
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Two sachets of probiotic daily for 5 days, product of Biology fermentation company
Category
Treatment - Drugs
2
Description
Control group: Two sachets of placebo daily for 5 days, product of Farabi company
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital of Kashan
Full name of responsible person
Dr Ahmad Najafi
Street address
Shahid Beheshti hospital, Ravandi boulevard
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5533 0489
Fax
+98 31 5554 8900
Email
najafi-a@kaums.ac.ir
Web page address
http://Beheshti.Kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Hamidreza Benafsheh
Street address
Deputy of research and technology, Kashan University of Medical Sciences, Ravandi boulevard
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
research@kaums.ac.ir
Web page address
https://research.kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Kashan University of Medical Sciences
Full name of responsible person
Dr َAhmad Najafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Third floor, Zagros building, Baran street, Shohada fin bozorg bulvard, Amerieh square, Amir Kabir street
City
Kashan
Province
Isfehan
Postal code
8718615699
Phone
+98 31 5533 0489
Email
a.najafi1975@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Ahmad Najafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Third floor, Zagros building, Baran street, Shohada fin bozorg bulvard, Amerieh square, Amir Kabir street
City
Kashan
Province
Isfehan
Postal code
8718615699
Phone
+98 31 5533 0489
Email
a.najafi1975@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr َAhmad Najafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Third floor, Zagros building, Baran street, Shohada fin bozorg bulvard, Amerieh square, Amir Kabir street
City
Kashan
Province
Isfehan
Postal code
8718615699
Phone
+98 31 5533 0489
Email
najafi-a@kaums.ac.ir
Web page address
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Journal file in website of deputy of research and technology of Kashan Medical Sciences
When the data will become available and for how long
since 2020
To whom data/document is available
Universities of Medical Science
Under which criteria data/document could be used
for the purpose of scientific exploitation
From where data/document is obtainable
Journal file in website of deputy of research and technology of Kashan Medical Sciences
What processes are involved for a request to access data/document
Search of journal title in website of deputy of research and technology of Kashan Medical Sciences