Investigating the effect of mouthwash containing an acidophilic strain of Lactobacillus brevis enriched with selenium on the microbial flora of the gastrointestinal tract and the healing of oral ulcers in ICU patients
Investigating the effect of mouthwash containing an acidophilic strain of Lactobacillus brevis enriched with selenium on the microbial flora of the gastrointestinal tract and the healing of oral ulcers in ICU patients of Shahid Bahonar Medical Center, Kerman.
Design
The number of patients studied in this project (sample size) will be at least sixty people who will be divided into three equal groups of twenty people (1. normal saline 0.9%, 2. chlorhexidine 0.12%, and 3. bacterial suspension enriched in normal solution Saline 0.9%)
This study is an interventional or clinical trial type and is conducted in a double blind method
Settings and conduct
This study is an interventional or clinical trial type and is conducted by double blind method (patient and caregiver and clinical outcome assessor) in the ICU department of Shahid Bahonar Medical Center in Kerman.
Participants/Inclusion and exclusion criteria
The criteria for entering the study are being hospitalized in the ICU department of Bahnar Hospital, not having sepsis, pneumonia or other active infection, and not having a known immunodeficiency. Also, according to the effect of obesity (body mass) and nutritional status of the patient (such as gavage tolerance) in the healing process of the wound, as well as the location of the wound, patients are matched (for intubated patients, cases where the intubation tube is cuffed are selected).
Intervention groups
The studied mouthwash group
Chlorhexidine mouthwash group
Normal saline mouthwash group (control)
Main outcome variables
Oral ulcer, digestive tract flora
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221221056887N1
Registration date:2023-03-06, 1401/12/15
Registration timing:prospective
Last update:2023-03-06, 1401/12/15
Update count:0
Registration date
2023-03-06, 1401/12/15
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
2023-04-21, 1402/02/01
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 mouthwash containing an acidophilic strain of Lactobacillus brevis enriched with selenium on the microbial flora of the gastrointestinal tract and the healing of oral ulcers in ICU patients
Public title
Investigating the effect of mouthwash containing an acidophilic strain of Lactobacillus brevis enriched with selenium on the microbial flora of the gastrointestinal tract and the healing of oral ulcers in ICU patients of Shahid Bahonar Medical Center, Kerman.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being hospitalized in the ICU department of Bahnar Hospital
No sepsis, pneumonia, or other active infection
No known immunodeficiency
For intubated patients, cases that the intubation tube is cuffed are selected
Exclusion criteria:
The patient was discharged from the ICU and anesthesia service of Bahnar Hospital
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
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 with conditions for entering the study will be divided into two equal groups, and the placement of people in these two groups will be in the form of block randomization with the blinding process (in If the total sample size is not available for block randomization at the beginning of the study, randomization using random number table method is used.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study has been double-blind, so that the patient, the clinical caregiver, the evaluator, and the outcome researcher do not know the type of mouthwash prescribed, and it is only prescribed based on mouthwash number 1, 2, and 3.
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
2023-02-06, 1401/11/17
Ethics committee reference number
IR.KMU.REC.1401.529
Health conditions studied
1
Description of health condition studied
oral ulcer
ICD-10 code
K12.1
ICD-10 code description
Other forms of stomatitis
2
Description of health condition studied
Changing the flora of the digestive tract
ICD-10 code
A09
ICD-10 code description
Infectious gastroenteritis and colitis, unspecified
Primary outcomes
1
Description
Oral ulcer
Timepoint
The entire duration of drug administration
Method of measurement
Observation and examination of the wound by the researcher(wound healing time AND Wound dimensions)
2
Description
Gastrointestinal flora
Timepoint
The beginning and the end of the study and according to the routine of the department
Method of measurement
The information available in the system and the response section of the patient's tests(Microbial flora of the pharynx)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The studied mouthwash (produced in Kerman University of Medical Sciences, Iran, where Lactobacillus isolated from dairy and edible products is cultured in an environment containing selenium salt to be enriched with selenium, and after laboratory approval of the bacteria for human use daily 4 50 cc of normal saline 0.9% containing 109 cfu of this probiotic for 30 seconds is prescribed for patients as a mouthwash for one week.
Category
Treatment - Drugs
2
Description
Intervention group: Chlorhexidine mouthwash (manufactured by Vi One-Iran, which is diluted to a concentration of 0.12% and then 50 cc of this mouthwash is prescribed to the patients 4 times a day for 30 seconds for a week)
Category
Treatment - Drugs
3
Description
Control group: normal saline 0.9% (manufactured by Iran-Iran company, which is used at a concentration of 0.9% and 50cc of this mouthwash is prescribed to patients 4 times a day for 30 seconds for a week)
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
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
2
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
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
Yes - There is 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