Evaluation of the Efficacy of Probiotic Supplementation on bio-markers of inflammation and oxidative stress in pediatric patients under treatment with hemodialysis: randomized double blind clinical trial
Study of the Effect of probiotic in pediatric patients under hemodialysis treatment
Design
Clinical trial with control group in patients under hemodialysis with parallel group in double-blind design and randomized
Settings and conduct
This clinical trial performed in hemodialysis pediatric patients in Doctor Sheikh hospital in a randomized double blind design
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Hemodialysis Patients during study period Two week after Discontinue antibiotics Two weeks after resolving acute inflammatory settings Two weeks after Discontinue probiotics
Exclusion Criteria Patients with Chronic Inflammatory Setting like glumerolonephritis or nephrotic syndrome Patients received antibiotic or under inflammatory setting like polmunary infection or gastroenteritis Candidate for transplantation Receiving immuno-suppressive drugs specially steroids Receiving probiotics for any reason
Intervention groups
Intervention group receive probiotics
Probiotic contain following strains : Lactobacillus casei ،Lactobacillus acidophilus ، Lactobacillus rhamnosus ، Lactobacillus bulgaricus، Bifidobacterium breve ، Bifidobacterium longum و Streptococcus thermophilus in the count of 109 CFU in 500 mg tablet from Zist Takhmir. Because these Bactria remain in the intestine and not absorb, nothing uptake during dialysis
Control group receive placebo
Main outcome variables
Total Antioxidant Capacity; Nuclear factor-kappa B, vascular cell adhesion molecule,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160206026390N11
Registration date:2019-06-10, 1398/03/20
Registration timing:retrospective
Last update:2019-06-10, 1398/03/20
Update count:0
Registration date
2019-06-10, 1398/03/20
Registrant information
Name
Ehsan Ghaedi
Name of organization / entity
Ahwaz Jundishapoor ,University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3285
Email address
ghaedi.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Efficacy of Probiotic Supplementation on bio-markers of inflammation and oxidative stress in pediatric patients under treatment with hemodialysis: randomized double blind clinical trial
Public title
Probiotics and children under hemodialysis treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodialysis Patients during study period
Two weeks after Discontinue antibiotics
Two weeks after resolving acute inflammatory settings
Two weeks after Discontinue probiotics
Exclusion criteria:
Patients with Chronic Inflammatory Setting like glumerolonephritis or nephrotic syndrome
Patients received antibiotic or under inflammatory setting like polmunary infection or gastroenteritis
Candidate for transplantation
Receiving immuno-suppressive drugs specially steroids
Receiving probiotics for any reason
Age
From 4 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization based on envelops
Allocation Concealment Sequentially numbered, opaque, sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding for patients performed based on placebo drugs which is based on placebo which is same in color, form and size
Physician is not informed about allocation in groups
Data analyzer do not know about groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Tohid Square, Taheri St. Shahid Gharani St. 6
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.204
Health conditions studied
1
Description of health condition studied
Pediatric under hemodialysis treatment
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
total Antioxidant Capacity
Timepoint
before and after intervention
Method of measurement
ELISA
2
Description
Nuclear Factor-kappa B
Timepoint
before and after intervention
Method of measurement
ELISA
3
Description
vascular cell adhesion molecule - 1
Timepoint
before and after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Timepoint
Method of measurement
2
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: Probiotic Intervention group receive probiotics Probiotic contain following strains : Lactobacillus casei ،Lactobacillus acidophilus ، Lactobacillus rhamnosus ، Lactobacillus bulgaricus، Bifidobacterium breve ، Bifidobacterium longum و Streptococcus thermophilus in the count of 109 CFU in 500 mg tablet from Zist Takhmir. Because these Bactria remain in the intestine and not absorb, nothing uptake during dialysis
Category
Treatment - Other
2
Description
Control group: placebo same in form, color and size
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor Sheikh Hospital
Full name of responsible person
Dr Mitra Naseri
Street address
Tohid Sqr., Taheri St., Gharani St., 6
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Tafaghodi
Street address
Razavi Khorasan, Mashhad, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
-
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
Mashhad University of Medical Sciences
Full name of responsible person
Mitra Naseri
Position
Pediatric Nephrologist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Mashahd, Daneshagah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Email
NaseriM@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bahareh Imani
Position
Pediatrician
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Mashhad, Daneshgah St.,
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Email
ImaniBH@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Ghaedi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Keshavarz Blvd., TUMS
City
Tehran
Province
Tehran
Postal code
14155-6617
Phone
+98 21 61111
Email
ehsanghaedi073@gmail.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
only with permission with supporter organization and also ethics committee would be shared.