Evaluation of whether probiotic use is associated with prevention/reduction of GVHD and predicting GVHD in these patients
Determining the effect of using familact probiotic drug in preventing and predicting GVHD
Design
A randomized controlled clinical trial in 2 groups and randomized in two groups.On the one hand, blind
Settings and conduct
This treatment is performed in the transplant department of Taleghani Hospital in collaboration with the Iranian Blood Transfusion Organization-
Intervention patients (n = 20) were given a probiotic capsule capsule daily before transplantation (-21 to transplant day) for 21 days and blood samples were collected in 5 CCs in 2 times. Indicates that Tregulatory testing and ST-2 and REG-3a plasma biomarkers will be tested. Each patient will be followed for up to 100 days.No control was used for the control group and only sampling would be performed on these two occasions
Participants/Inclusion and exclusion criteria
Patients who are candidates for allogeneic bone marrow transplant
1- Patient consent and consent provided with the approval of the Ethics Committee form
2- 20 to 50 years
3. The source of the transplanted tissue of all patients is peripheral blood stem cells
4 - The connective tissue for HLA is fully compatible with the patient's HLA
5. The prophylaxis diet should be the same to prevent their GVHD
6. All patients use blood and radiation products
Exclusion criteria:
1. The patient's withdrawal from continuing study and drug use
2. The incidence of severe blood infection and severe diarrhea in patients
3. Fever above 38.5 degrees
4. Absolute neutrophil count less than 500 (ANC <500)
Intervention groups
Intervention group: Patients who have undergone bone marrow allogeneic transplantation and received a food-licensed probiotic drug as a supplement
Control group: No medication
Main outcome variables
GVHD prevention, GVHD prediction,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190914044766N1
Registration date:2020-01-28, 1398/11/08
Registration timing:registered_while_recruiting
Last update:2020-01-28, 1398/11/08
Update count:0
Registration date
2020-01-28, 1398/11/08
Registrant information
Name
Ehsan Yazdandoust
Name of organization / entity
High institute for research and education in transfusion medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 4446 0620
Email address
e.yazdandoust@tmi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Graft versus host disease prevention/reduction by microbiome and patient blood management in allogeneic hematopoietic stem cell transplant patients
Public title
Graft versus host disease prevention/reduction by microbiome and patient blood management in allogeneic hematopoietic stem cell transplant patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for allogeneic bone marrow transplant who have been referred for transplantation to Taleghani Hospital for treatment of blood malignancies
Age 20 to 50 years
The source of the transplanted tissue of all patients is peripheral blood stem cells
HLA transplanted tissue to be fully compatible with patient HLA (fully compatible with primary HLA A , B and DR-B1 )
The prophylaxis diet should be the same to prevent GVHD
All patients use irradiated blood and products
Exclusion criteria:
Patients who did not have allogeneic bone marrow transplantation
Patient dissatisfaction
Having an infection or fever above 38.5 ° C before entering the study
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
The intervention group received 20 capsules of familact probiotic orally daily and the control group received no medication. Blood samples are taken from both groups twice
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into control and intervention groups
Based on random number table
We assign a number to each patient based on the time patients visit and perform randomization using a random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of High Institute for Education and Research in Transfusion Medicine
Street address
ehran Province, Tehran, District 2, Hemmat Expy
City
Tehran
Province
Tehran
Postal code
115714665
Approval date
2019-12-16, 1398/09/25
Ethics committee reference number
IR.TMI.REC.1398.023
Health conditions studied
1
Description of health condition studied
graft versus host disease
ICD-10 code
D89.81
ICD-10 code description
Graft-versus-host disease
2
Description of health condition studied
acute graft versus host disease
ICD-10 code
D89.810
ICD-10 code description
Acute graft-versus-host disease
Primary outcomes
1
Description
Occurrence of graft-versus-host disease (GVHD)
Timepoint
They are followed up clinically for up to 100 days after transplantation
Method of measurement
Using clinical evidence that occurs in the patient and the physician's opinion
2
Description
The grade and severity of graft-versus-host disease
Timepoint
They are followed up clinically for up to 100 days after transplantation
Method of measurement
Using clinical evidence that occurs in the patient and the physician's opinion
3
Description
The rate and percentage of regulatory T in patients
Timepoint
Day 7 and 28 after transplantation
Method of measurement
روش آزمایشگاهی فلوسایتومتری
4
Description
Plasma levels of reg3a and ST-2
Timepoint
Day 7 and 28 after transplantation
Method of measurement
ELISA Laboratory Method
Secondary outcomes
1
Description
Improve and reduce gastrointestinal complications
Timepoint
Up to 10 days after transplant
Method of measurement
Patient clinical statements
Intervention groups
1
Description
Intervention group: Intervention group:20 Patients reported for allogeneic bone marrow transplantation: who consume one day of graft probiotic capsule daily for 21 days before transplantation until the day of transplantation./It should be noted that familact is a probiotic and prebiotic compound containing 7 strains of beneficial bacteria (Lactobacillus, Bifidobacteria and Streptococcus thermophilus) plus Prebiotic Fructoaligosaccharide)
Category
Treatment - Drugs
2
Description
Control group: 20 patients reported for allogeneic bone marrow transplantation and not taking any additional medication
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bone Marrow Transplantation Department of Taleghani Hospital
Full name of responsible person
DR Abbas Hajifathali
Street address
Taleghani Educational Hospital, Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran,
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
taleghanihospital@sbmu.ac.ir
Web page address
http://taleghani.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
High Institute for Research and Education in Transfusion Medicine
Full name of responsible person
Mahtab Maghsudlu
Street address
High Institute for Research and Education in Transfusion Medicine, Shahid Hemmat, Next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1157-14665
Phone
+98 21 8860 1501
Email
Maghsudlu@ibto.ir
Web page address
https://tmi.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
High Institute for Research and Education in Transfusion Medicine
Proportion provided by this source
80
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
high institute for research and education in transfusion medicine
Full name of responsible person
Ehsan Yazdandoust
Position
phd candidate
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
high institute for research and education in transfusion medicine , hemmat,Next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1157-14665
Phone
+98 21 8860 1586
Fax
+98 21 8806 0717
Email
yazdandouste@gmail.com
Web page address
https://tmi.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
high institute for research and education in transfusion medicine
Full name of responsible person
Ehsan Yazdandoust
Position
phd candidate
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
high institute for research and education in transfusion medicine, Floor 7, Quality Assurance Division
City
Tehran
Province
Tehran
Postal code
1157-14665
Phone
+98 21 8670 5503
Email
yazdandouste@gmail.com
Web page address
https://tmi.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
High institute for research and education in transfusion medicine
Full name of responsible person
Ehsan Yazdandoust
Position
phd student
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
High institute for research and education in transfusion medicine, Floor 7, Quality Assurance Division
City
Tehran
Province
Tehran
Postal code
1157-14665
Phone
+98 21 4446 0620
Email
yazdandouste@gmail.com
Web page address
https://tmi.ac.ir/
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
Information on the main outcome is added and published
When the data will become available and for how long
The publication begins after the paper is published after the research is completed
To whom data/document is available
Information will be made available to all researchers
Under which criteria data/document could be used
Use of published articles from this study , For more details and details, please contact the corespondent author of the paper published in this research
From where data/document is obtainable
Ehsan Yazdandoust
yazdandouste@gmail.com
09107434515
Corresponding author of published research articles
What processes are involved for a request to access data/document
After contacting the information provider, the information will be made available to the applicant within two weeks. This will be the posting of the information after the articles are published
Comments
Most of the essential information was provided to the researchers by the publication of the article