The effect of probiotic on therapy of thermal burn in children
Design
A prospective , with controlled parallel group, randomized , double- blind clinical trial, phase 2 of 100 patients. For randomization we used rand function of Excel software
Settings and conduct
This is a prospective , randomized , double- blind clinical trial in which patients and investigator are bind to content of packages. By random allocation , the patients will divide to two group (n=50)
Participants/Inclusion and exclusion criteria
Inclusion criteria
- Children between 1-15 years old
- Total body surface of burn 10-50%
- Deep area of burn 5-10%
Exclusion criteria
- Children with history of chronic GI diseases
- Children with history of chronic diseases for example diabetes
- Children with upper respiratory tract burn and inhalation injury
- Children with known hereditary and immunodeficiency
- Children with electrical and chemical burn
Intervention groups
Case group will take probiotic
Control group will take placebo
Main outcome variables
The main outcomes of this study including decrease in infection rate; the length of hospital stay; the need to skin graft and mortality in children with thermal burn
General information
Reason for update
Acronym
پروبیوتیک در سوختگی
IRCT registration information
IRCT registration number:IRCT20210708051822N1
Registration date:2021-08-02, 1400/05/11
Registration timing:prospective
Last update:2021-08-02, 1400/05/11
Update count:0
Registration date
2021-08-02, 1400/05/11
Registrant information
Name
Hossein Masoumi-Asl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4438 0119
Email address
masoumiasl.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotics in the therapy of Pediatrics thermal Burn: A prospective double- blind, controlled clinical trial
Public title
Effect of probiotics in the therapy of Pediatrics Burn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children between 1-15 years old
Burn with total body surface area 10-50%
Burn with deep area between 5-10%
Exclusion criteria:
Children with chronic GI diseases
Children with chronic diseases for example diabetes
Children with upper respiratory tract or inhalation injury
Children with hereditary and congenital immune system disorders
children with chemical and electrical burn
Age
From 1 year old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After hospitalization, patients will be divided in two group of case (probiotic) and control(placebo) by simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The packages of probiotic and placebo will be designed in the same form.
Only principle investigator knows the content of packages . Patient and investigator or clinician are blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
Ethics Committees of Iran University of Medical Sciences, Central building of Iran University of Medical Sciences, next to Milad tower, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-06-12, 1400/03/22
Ethics committee reference number
IR.IUMS.REC.1400.277
Health conditions studied
1
Description of health condition studied
Thermal Burn in children
ICD-10 code
T20-T32
ICD-10 code description
Burn and corrosion
Primary outcomes
1
Description
The rate of infection in thermal burn of children
Timepoint
Zero (admission day), 4, 7 and 14 day and until one year after hospitalization
Method of measurement
To calculate the number of positive culture reported by laboratory in thermal burn of children according to patients file.
2
Description
The length of hospital stay in thermal burn of children
Timepoint
Time of discharge or death
Method of measurement
To calculate the length of hospital stay on the time of discharge or death according to patients file.
3
Description
The need to skin graft in thermal burn of children
Timepoint
From discharge until one year
Method of measurement
To calculate the number of skin graft from discharge until one year according to patients file.
4
Description
Mortality due to thermal burn of children
Timepoint
From hospitalization until one year
Method of measurement
The mortality rate ( the proportion of death to number of hospitalized patients) in thermal burn of children
Secondary outcomes
1
Description
Length of hospital stay
Timepoint
Date of discharge and one year after burn
Method of measurement
Number of hospitalized days
2
Description
The need to skin graft
Timepoint
From discharge until one year after burn
Method of measurement
The number of skin grafts
Intervention groups
1
Description
Intervention group: Probiotic supply group that will receive oral package including 1- lactobacillus rhamnosus 2- lactobacillus rotteri 3- lactobacillus acidophilus 4-lactobacillusbulgaricus 5- lactobacillus casei 6-Bifidobacterium infantis 7-Bifidobacterium breve 8-Bifidobacterium bifidum 9-Bifidobacterium lactis 10- Streptococcus thermophilus with density of CFU 109 plus prebiotic of Fructooligosaccharides. This package is Gluten free and produced by Farabiotic Company . This oral powder will be used twice daily for 14 days by 50 cases of control group.
Category
Treatment - Other
2
Description
Control group: They will receive a package of placebo including food material and in the same form of probiotic package. The oral placebo is produced by Farabiotic company and will be used by 50 cases of control group twice daily for 14 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Burn Hospital
Full name of responsible person
Hossein Masoumi Asl
Street address
Shahid Motahari Burn Hospital Yasami Ave, Valiasr St, Tehran
City
تهران
Province
Tehran
Postal code
1196714353
Phone
+98 21 8888 4275
Fax
+98 21 8888 4275
Email
burncenter.iran@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motavalian
Street address
Research and Technology deputy, Iran University of Medical Sciences, next to Milad tower, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hossein Masoumi Asl
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
No 9, Frereshte yekom Ave, Fereshteghak St, Marzdaran Blv, Tehran
City
تهران
Province
Tehran
Postal code
1463774188
Phone
+98 21 4438 0119
Email
masoumiasl.h@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Masoumi Asl
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
No. 9, Fereshte yekom, fereshteghan st. , Marzdaran Blv, Tehran
City
Tehran
Province
Tehran
Postal code
1463774188
Phone
+98 21 4438 0119
Email
masoumiasl.h@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Masoumi Asl
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
No 9, Frereshte yekom Ave, Fereshteghak St, Marzdaran Blv, Tehran
City
Tehran
Province
Tehran
Postal code
1463774188
Phone
+98 21 4438 0119
Email
masoumiasl.h@iums.ac.ir
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