Effect of Probiotic on uremic toxins and quality of life in hemodialysis patients
Design
Trial has one group and intervention is the same for everyone
Settings and conduct
Sixty patients from chronic hemodialysis patients are selected from the hemodialysis center of Sina Hospital in Tabriz based on inclusion and exclusion criteria. Before starting the study, quality of life and assessment of the parameters listed above will be measured by taking 5cc of complete blood and then patients will recieve 1 Daily Yeast capsule each day for 4 months. At the end of the study, measurements of these parameters and patient's quality of life will be re-evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 18 years, Begining of hemodialysis from previous 3 months and three times a week; The ability to understand and sign the consent form; Use of biocompatible dialysis membrane; Properly functioning arteriovenous fistula or catheter
Exclusion criteria:
Pregnancy and lactation; Use of broad-spectrum antibiotics in the last 3 months or now; Allergy to probiotics, The presence of any chronic, active, uncontrolled or severe chronic inflammatory disease (autoimmune diseases, connective tissue disease, malignancy, HIV, liver disease and pulmonary disease); chronic or acute infection in a recent month; Co-administration in another trial; A history of stroke or myocardial infarction in the last 3 months; Receiving medications which are effective on inflammatory factors (corticosteroids or other immunosuppressive drugs, nonsteroidal anti-inflammatory drugs, contraceptives, pentoxifylline)
Intervention groups
Intervention group: Consists of 60 hemodialysis patients receiving 1 Daily Yeast 500mg produced by Zist takhmir factory once daily for 4 months
Main outcome variables
Serum Concentration of Indoxyl sulfate, p-Cresyl Sulfate, p-cresol and Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170609034406N4
Registration date:2020-02-07, 1398/11/18
Registration timing:retrospective
Last update:2020-02-07, 1398/11/18
Update count:0
Registration date
2020-02-07, 1398/11/18
Registrant information
Name
Afshin Gharekhani
Name of organization / entity
Faculty of Pharmacy/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1315
Email address
gharekhania@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-03, 1398/01/14
Expected recruitment end date
2019-06-04, 1398/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic (Saccharomycesboulardi) on uremic toxins and quality of life in patients with chronic hemodialysis.
Public title
The effect of probiotic on uremic toxins and quality of life in chronic hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Begining of hemodialysis from previous 3 months for three times a week
Ability to understand and sign a consent form
Use of biocompatible dialysis membrane
Properly functioning arteriovenous fistula or catheter
Exclusion criteria:
Pregnancy and lactation
Use of broad-spectrum antibiotics in the last 3 months or now
Allergy to probiotics
The presence of any chronic, active, uncontrolled or severe chronic inflammatory disease (autoimmune diseases, connective tissue disease, malignancy, HIV, liver disease and pulmonary disease)
The presence of chronic or acute infection in a recent month
Concurrently presence in another trial (drug or supplement)
A history of stroke or myocardial infarction in the last 3 months
Receiving medications which are effective on inflammatory factors (corticosteroids or other immunosuppressive drugs, nonsteroidal anti-inflammatory drugs, contraceptives, pentoxifylline)
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Center of Research and Technology, No 2 Central Building , Tabriz University of Medical Sciences , Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2019-01-07, 1397/10/17
Ethics committee reference number
IR.TBZMED.REC.1397.784
Health conditions studied
1
Description of health condition studied
hemodialysis patients
ICD-10 code
Z49.01
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
Serum level of Indoxyl Sulphate
Timepoint
Before intervention-At the end of intervention
Method of measurement
ELISA kit
2
Description
Serum level of P-cresyl sulphate
Timepoint
Before intervention-At the end of intervention
Method of measurement
ELISA kit
3
Description
Serum level of P-cresol
Timepoint
Before intervention-At the end of intervention
Method of measurement
ELISA kit
Secondary outcomes
1
Description
Quality of life
Timepoint
Before intervention-At the end of intervention
Method of measurement
Short form (36) quality of life survey
Intervention groups
1
Description
Intervention group: The treatment group consists of 60 patients receiving Daily Yeast 500 mg produced by Zist takhmir factory, once daily for 4 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Afshin Gharekhani
Street address
Sina Medical Research & Training Hospital, between Shahid montazeri & Hafez squares, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8342
Email
gharekhania@tbzmed.ac.ir
Web page address
https://sinahosp.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Abolghasem Jouyban
Street address
Drug Applied Research Center Medical Research and Development Complex, Daneshgah St., Tabriz-Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3335 5921
Email
gharekhania@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy-Tabriz university of medical science-Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3335 5921
Email
gharekhania@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy-Tabriz university of medical science-Daneshgah avenue-Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5153
Email
gharekhania@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy-Tabriz university of medical science- Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3335 5921
Email
gharekhania@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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