Investigating the effect of an acidophilic Lactobacillus brevis strain enriched with selenium on bedsores of ICU(Intensive care unit) patients of Shahid Bahonar Medical Center, Kerman
Design
Initially, the initial sample size is 40 patients and they are divided into two groups of 20 subjects and controls. It is an intervention study or clinical trial
During hospitalization in the ICU(Intensive care unit) department, 109 CFU of Selenium-enriched Lactobacillus brevis is administered once a day for 2 weeks.
Settings and conduct
It is performed in a double blind method in the ICU(Intensive care unit) department of Shahid Bahonar Medical Center in Kerman, and the patient, clinical caregiver, and outcome evaluator are not informed about the type of capsule consumed.
Participants/Inclusion and exclusion criteria
The criteria for entering the study are having a bed sore (stage 1 and 2), not receiving other probiotics, being hospitalized in the ICU(Intensive care unit) department of Bahnar Hospital, not having sepsis, pneumonia, other active infection, and known immunodeficiency. The criterion for exiting the plan is the patient's exit from the ICU and anesthesia service of Bahonar Hospital
Intervention groups
In this plan, we have a control group (placebo) and a study group at the same time, and the intended placebo substance is maltodextrin.
Main outcome variables
bedsore
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221221056887N2
Registration date:2023-05-12, 1402/02/22
Registration timing:prospective
Last update:2023-05-12, 1402/02/22
Update count:0
Registration date
2023-05-12, 1402/02/22
Registrant information
Name
Farshid Ataollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 8942
Email address
farshid.ataollahi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of an acidophilic Lactobacillus brevis strain enriched with selenium on bedsores of ICU patients
Public title
Investigating the effect of an acidophilic Lactobacillus brevis strain enriched with selenium on bedsores of ICU patients of Shahid Bahonar Medical Center, Kerman
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having bedsores (stage 1 and 2)
Not receiving other probiotics
Being hospitalized in the ICU department of Bahnar Hospital
Not having sepsis, pneumonia, other active infection and known immunodeficiency
Exclusion criteria:
The patient was discharged from the ICU and anesthesia service of Bahnar Hospital
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
After examining the patients in terms of the criteria for entering the study and obtaining informed consent, the total number of people eligible to enter the study will be divided into two equal groups of 40 people, and the placement of people in these two groups will be done by block randomization along with the blinding process. It was like this that in the randomization, people are placed in two groups randomly and completely randomly, and in order to equalize the number of people in the two groups, block randomization will be done if needed (if the total sample size at the beginning of the study for If block randomization is not available, then randomization is used by the random number table method in such a way that we divide the number of people into two groups based on the random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study has been double-blind in that the patient himself does not know the type of capsule received, and also the treatment staff such as the clinical supervisor and project researchers such as the evaluator of the investigated factors and the outcome researcher do not know the type of capsule prescribed and only based on Capsule number 1 and 2 are prescribed and will be determined at the time of data analysis
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Jahad Blvd. Ebn Sina Avenue, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-05-01, 1402/02/11
Ethics committee reference number
IR.KMU.REC.1402.038
Health conditions studied
1
Description of health condition studied
bedsores
ICD-10 code
L89
ICD-10 code description
Pressure ulcer
Primary outcomes
1
Description
Bedsore
Timepoint
The entire duration of drug administration
Method of measurement
Observation and examination of the wound by the researcher (wound healing time, wound dimensions and wound stage)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: studied probiotic (probiotic capsule - containing 109 cfu of Lactobacillus isolated from dairy and edible products, which is cultured in an environment containing selenium salt to be enriched with selenium, and after laboratory confirmation of the bacteria, it is used in the study for human use - manufacturing Kerman University of Medical Sciences - Iran, which is prescribed to the patient once a day for 2 weeks, and if the patient is intubated, it is given to the patient through the NG tube, which is installed in the ward for patients with reduced level of consciousness.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Placebo capsule or placebo contains 50 grams of maltodextrin made in Iran, which is prescribed to the patient once a day for 2 weeks, and if the patient is intubated, it is inserted through the NG tube in the ward for patients with reduced level of consciousness. is given to the patient)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar hospital
Full name of responsible person
Farshid Ataollahi
Street address
Qorani St. - Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarhospital@kmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Biotechnology Development Headquarters
Full name of responsible person
Ruhollah Dehghani Firouzabadi
Street address
scientific and technological department of presidential office, No,. 20, Ladan alley, North Sheikh Bahayee St., MollaSadra St., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1991745681
Phone
+98 24 83539
Email
pr@isti.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Biotechnology Development Headquarters
Proportion provided by this source
50
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
Other
2
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Ebn-e-Sina St.,Jahad Blvd.,
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
kmu@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
50
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
Kerman University of Medical Sciences
Full name of responsible person
Farshid Ataollahi
Position
Non-faculty general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Qaraney St, Next to Shahid Bahonar Hospital, Upper Floor 0f Pharmacy No.2 , Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616911319
Phone
+98 34 3223 8942
Fax
+98 34 3223 8942
Email
farshid.ataollahi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farshid Ataollahi
Position
Non-faculty general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Qaraney St, Next to Shahid Bahonar Hospital, Upper Floor 0f Pharmacy No.2 , Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616911319
Phone
+98 34 3223 8942
Fax
+98 34 3223 8942
Email
farshid.ataollahi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farshid Ataollahi
Position
Non-faculty general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Qaraney St, Next to Shahid Bahonar Hospital, Upper Floor 0f Pharmacy No.2 , Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616911319
Phone
+98 34 3223 8942
Fax
+98 34 3223 8942
Email
farshid.ataollahi@gmail.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
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
Project data will be published without mentioning personal information and identification of study subjects
When the data will become available and for how long
Access starts from the publication of the final report
To whom data/document is available
The data that can be published is published in the form of a final report and is available to everyone
Under which criteria data/document could be used
The data that can be published will be announced in the final report of the plan
From where data/document is obtainable
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
What processes are involved for a request to access data/document