Investigating the effect of probiotic in preventing jaundice in newborns.
Design
Clinical trials with control group and parallel groups, double blinded and randomization is done by using table of numbers, and 100 infants in each group
Settings and conduct
The study was conducted double blindly and infants who were born in Ghaem Hospital of Mashhad included, taking the drug will Start first day of the birth.
Participants/Inclusion and exclusion criteria
inclusion criteria: Infants with pregnancy age greater than 37 weeks, Birth weight is more than 2500 grams, Parental Satisfaction
Intervention groups
In the Intervention group infants will use a daily yummy capsule (containing 250 mg dry yeast or 1010 Bullardian Saccharomyces organisms for 5 days and in control group placebo capsule will be used in the same way.
Main outcome variables
Amount of bilirubin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130308012743N2
Registration date:2019-10-05, 1398/07/13
Registration timing:retrospective
Last update:2019-10-05, 1398/07/13
Update count:0
Registration date
2019-10-05, 1398/07/13
Registrant information
Name
Ezat Khodashenas
Name of organization / entity
Mashhad University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 51 1727 3943
Email address
khodashenase@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of probiotics in preventing jaundice in newborns.
Public title
Study the effect of Probiotics on Neonatal Jaundice Prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Infants with pregnancy age greater than 37 weeks
Birth weight is more than 2500 grams
Parental Satisfaction
Exclusion criteria:
risk factor for jaundice
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization is performed using random number table through www.randomazation.com and sealed envelope. First, the purpose of the study is explained to the person who meets the requirements, and if the person wishes to sign an informed consent form, they will remove an envelope and place it in the intervention or control group based on the contents of the envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blind and after full explanation for the newborn's parents and informed consent, they were placed in the intervention and control groups without knowing which group they were in, The person who intervenes does not know which person belongs to which group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی مشهد
Street address
Ghoreishi building, Daneshgah AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Approval date
2018-02-14, 1396/11/25
Ethics committee reference number
IR.MUMS.fm.REC.1396.810
Health conditions studied
1
Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Amount of bilirubin
Timepoint
Before the intervention and 3 and 5 days after taking the probiotic capsule
Method of measurement
Skin bilirubinometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Infants will use a daily yummy capsule (containing 250 mg dry yeast or 1010 Bullardian Saccharomyces organisms) for 5 days.
Category
Prevention
2
Description
Control group: Infants in the control group will take one daily capsule of placebo for 5 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Ezzat Khodashenase
Street address
Ahmad abad AVE, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2780
Email
khodashenase@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghoreishi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Robabeh moosavinesuad chenarani
Position
Non-faculty specialist
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ahmadabad AVE Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2780
Email
moosavinesuad_s@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ezzat khodashenase
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Ahmadabad AVE Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2780
Email
khodashenase@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ezzat Khodashenase
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Ahmadabad AVE Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2780
Email
khodashenase@mums.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