ٍEffect of probiotic (Lactobacilus sporogenesis) in reducing PELD score in pediatric cholestatic liver disease: Randomized double blinded clinical trial
Design
The convince sampling method is goal-based. In this way, the researcher is present at the site during the study and starts sampling from the referring patients in an accessible way to get the total sample size. Randomization method: permutation block design or quadruple blocks will be used
Settings and conduct
Children with cirrhosis who refer to Shiraz pediatric liver Cirrhosis Cohort Center located in Motahhari clinic
Participants/Inclusion and exclusion criteria
Cirrhotic children who refereed to Motaharei clinic in Shiraz.
inclusion criteria: age 1-12 years. cholestatic liver disease. signed informed consent
Exclusion criteria:Taking antibiotics for four weeks before the study, history of gastrointestinal bleeding or SBP over the past two months, active microbial infection, taking immunosuppressive drugs or Immunosuppressed patients , renal failure (more creatinine From 1.5 mg) electronic imbalance (serum sodium <130 or> 150 meq / dl, serum potassium <3.0 or> 5.5 meq / dl), people with a history of allergies
Intervention groups
Lactobacilus sporogenesis probiotic is given in drops for 1 month (5 drops per day in 2 intervals) to treatment group.
Main outcome variables
PELD score: age, total Bili, Alb, INR, History of growth failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200628047940N1
Registration date:2020-07-21, 1399/04/31
Registration timing:prospective
Last update:2020-07-21, 1399/04/31
Update count:0
Registration date
2020-07-21, 1399/04/31
Registrant information
Name
Nasrin Motazedian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1529
Email address
nmotazedi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2021-01-04, 1399/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic (Lactobacilus sporogenesis) in reducing PELD score in pediatric cholestatic liver disease:Randomized double blinded clinical trial
Public title
Effect of probiotic in pediatric cholestatic liver disease
Taking antibiotics for four weeks before the study
Active microbial infection
History of gastrointestinal bleeding over the past two months
History of SBP over the past two months
Taking immunosuppressive drugs
Immunosuppressed patients
Renal failure ( creatinine> 1.5 mg)
Electronic imbalance (serum sodium <130 or> 150 meq / dl, serum potassium <3.0 or> 5.5 meq / dl)
History of Allergies
Age
From 1 year old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The convince sampling method is goal-based. In this way, the researcher is present at the site during the study and starts sampling from the referring patients in an accessible way to get the total sample size. Randomization method: permutation block design or quadruple blocks will be used
Blinding (investigator's opinion)
Double blinded
Blinding description
The physician will examine the patient and evaluate the laboratory tests under blinded conditions.The case and control groups are also unaware of the nature of the drops (probiotic, and placebo).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Ethics Commitee, Shiraz University of Medical Sciences, Zand Street, Beside Helal Ahmar, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2020-06-02, 1399/03/13
Ethics committee reference number
IR.SUMS.REC.1399.277
Health conditions studied
1
Description of health condition studied
Cholestatic liver disease in children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in Pediatric End-Stage Liver Disease (PELD) score
Timepoint
The results of Lab test for calculation of Pediatric End-Stage Liver Disease (PELD) score will be evaluated one month, three months after finishing the intervention.
Method of measurement
Pediatric End-Stage Liver Disease (PELD) Score = 0.480 × Loge (bilirubin mg/dL) + 1.857 × Loge (INR) - 0.687 × Loge (albumin g/dL) + 0.436 (if the patient is less than 1 year old) + 0.667 if the patient has growth failure (< -2 Standard deviation). Then multiply the score by 10 and round to the nearest whole number.
Secondary outcomes
1
Description
Improvement in growth and development
Timepoint
Three months after finishing the study
Method of measurement
Measuring weight by scale and height by stadiometer
Intervention groups
1
Description
Intervention group: The treatment group will be received Lactobacilus sporogenesis probiotic is given in drops for 1 month (5 drops per day in two intervals)
Category
Treatment - Drugs
2
Description
Control group: placebo drops is given in drops for 1 month (5 drops per day in two intervals) to control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Transplant Research Center
Full name of responsible person
Nasrin Motazedian
Street address
Seventh floor, Transplant Research Center, Research Tower, Mollasadra St., Khalili Ave., Shiraz, IR Iran.
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3628 1529
Email
motazediann@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Motazedian
Street address
Seventh floor, Transplant Research Center, Research Tower, Mollasadra St., Khalili Ave., Shiraz, IR Iran.
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3628 1529
Email
motazediann@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Shiraz University ofMedical Sciences
Proportion provided by this source
60
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
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Motazedian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Seventh floor, Transplant Research Center, Research Tower, Mollasadra St., Khalili Ave., Shiraz, IR Iran.
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3628 1529
Email
motazediann@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Motazedian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Seventh floor, Transplant Research Center, Research Tower, Mollasadra St., Khalili Ave., Shiraz, IR Iran.
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3628 1529
Email
motazediann@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Motazedian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Seventh floor, Transplant Research Center, Research Tower, Mollasadra St., Khalili Ave., Shiraz, IR Iran.
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3628 1529
Email
motazediann@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
The patients selected by convince sampling
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
gender
age
underlying disease
drugs
INR
AST
ALT
growth and development chart
When the data will become available and for how long