The effect of probiotics as an adjunctive therapy with mortality outcome, length and rate of hospitalization in Intensive Care Unit in patients with COVID-19
Investigation the effect of probiotics as an adjunctive therapy with mortality outcome, length and rate of hospitalization in Intensive Care Unit in patients with COVID-19
Design
This three-blind and parallel clinical trial study will be conducted on two groups of 30 patients with corona virus hospitalized in Razi Medical Education Center in Rasht.
Settings and conduct
Corona patients hospitalized in Razi Hospital, Rasht, in a three-blind manner and in two groups of 30 people randomly receive standard treatment with or without Lactocare probiotic.
Participants/Inclusion and exclusion criteria
Inclusion: Patients who are hospitalization due to COVID-19. Patients should be 18 years old and older. Patients should have clinical symptoms and pneumonia of covid in chest radiography or CT scan. Patients should not particitaion in other clinical trials at the same time.
exclusion: COPD,cancer, Liver disease or cirrhosis
Intervention groups
Experimental group standard treatment and lactocare
control group standard treatment and placebo
Main outcome variables
Admission to ICU, need to intubation, mortality, vital signs, cough, dyspnea, diarrhea, abdominal pain, length of hospitalization, o2 saturation, Hb, Platelet, ESR, CRP, WBC,lymphocyce, NLR,CPK, ALT, AST, fibrinogen, D-dimer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220124053820N1
Registration date:2022-09-19, 1401/06/28
Registration timing:registered_while_recruiting
Last update:2022-09-19, 1401/06/28
Update count:0
Registration date
2022-09-19, 1401/06/28
Registrant information
Name
Shadi Dehghanzadeh
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3344 5689
Email address
shadidehghan90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-06, 1401/06/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotics as an adjunctive therapy with mortality outcome, length and rate of hospitalization in Intensive Care Unit in patients with COVID-19
Public title
Investigation the effect of probiotics in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are hospitalization due to COVID-19. Patients should be 18 years old and older. Patients should have clinical symptoms and pneumonia of covid in chest radiography or CT scan. Patients should not particitaion in other clinical trials at the same time.
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To equalize the number of patients in two groups, block randomization method is used. For randomization, random fixed block method is used in blocks of 4. In such a way that two samples from the experimental group and two samples from the control group are allocated in each block.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients in two groups do not know which group they are in. For this reason, placebo is used to pay attention to the psychological aspect and acceptance of the patient.
The infectious disease specialist who is in charge of treating the patients also does not know which group the patient belongs to.
The patient assessor, who collects data related to the disease and outcomes, does not know which group the patient belongs to.
Patients (experimental group or control group) receive the medicine in sealed envelopes that are coded. Coding is done by one of the collaborators of the project and the patient, doctor and evaluator are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Thics committee of Lahijan Islamic azad University
Street address
Islamic azad University Lahijan branch, 45 meter university Blvd, lahijan
City
lahijan
Province
Guilan
Postal code
44169-39515
Approval date
2022-06-12, 1401/03/22
Ethics committee reference number
IR.IAU.LIAU.REC.1401.027
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
COVID-19
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Need to admission to ICU
Timepoint
Daily
Method of measurement
By evaluator using patient's file and ward's information
2
Description
Need to intubation
Timepoint
Daily
Method of measurement
By evaluator using patient's file and ward's information
3
Description
Mortality
Timepoint
Daily
Method of measurement
By evaluator using patient's file and ward's information
4
Description
Vital signs
Timepoint
Three times a day
Method of measurement
By evaluator using mercury sphygmomanometer and tاermometer
The intervention group receives probiotic Lactocare 500 mg capsules produce by Zist Takhmir company twice a day in addition to the treatment prescribed by the infectious disease specialist.
Category
Treatment - Drugs
2
Description
The control group receives the treatment prescribed by the infectious disease specialist along with the placebo capsules produced by Zist Takhmir company twice a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Dr Shadi dehghanzadeh
Street address
Rasht Islamic azad University, Pole taleshan, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3344 5689
Email
shadidehghan90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Rasht Islamic Azad University and Zist Takhmir company
Full name of responsible person
Dr Alireza Seidavi
Street address
Rasht Islamic Azad University, Pole taleshan, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 911 331 3073
Email
alirezaseidavi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Rasht Islamic Azad University and Zist Takhmir company
Proportion provided by this source
20
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
Rasht Islamic Azad University
Full name of responsible person
Dr Shadi dehghanzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rasht Islamic Azad University,Pole taleshan, rasht
City
Rasht
Province
Guilan
Postal code
۵۴۹۱۹-۴۱۴۷۶
Phone
+98 54 9194 1476
Email
shadidehghan90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Aydin Pourkazemi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Guilan University of Medical Sciences, Parastar Ave, Rasht
City
Rasht
Province
Guilan
Postal code
4193713111
Phone
+98 13 3332 6061
Email
Aydinpourkazemi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht Islamic Azad University
Full name of responsible person
Dr Shadi dehghanzadeh
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rasht Islamic Azad University, Pole taleshan, Rasht
City
Rasht
Province
Guilan
Postal code
۵۴۹۱۹-۴۱۴۷۶
Phone
+98 13 3344 5689
Email
shadidehghan90@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available