Effect of probiotic consumption versus placebo in lactating mothers with low birth weight or very low birth weight infants on weight gain, serum bilirubin level and the incidence of necrotizing enterocolitis: a triple-blind randomized clinical trial
To assess the effect of probiotic consumption versus placebo in lactating mothers with low birth weight or very low birth weight infants on weight gain, serum bilirubin level and the incidence of necrotizing enterocolitis
Design
This is a triple-blind randomized clinical trial with control group, phase III, in which eligible 60 eligible lactating mothers with low birth weight or very low birth weight infants will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Fatemieh Hospital in Hamadan city on 60 eligible lactating mothers with low birth weight or very low birth weight infants. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be triple-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 15 to 45 years
Mothers with low birth weight or very low birth weight infants
Exclusion criteria:
A baby who is not able to feed with breast milk
Intervention groups
Intervention group:
Oral Kidilact sachet (probiotic + prebiotic) 1 gr once daily for 28 days
Control group:
Oral placebo (starch) sachet once daily for 28 days
Main outcome variables
Primary outcome:
The mean weight of the baby, the mean serum bilirubin
Secondary outcome:
occurrence of necrotizing enterocolitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N466
Registration date:2023-03-30, 1402/01/10
Registration timing:prospective
Last update:2023-03-30, 1402/01/10
Update count:0
Registration date
2023-03-30, 1402/01/10
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2024-04-03, 1403/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic consumption versus placebo in lactating mothers with low birth weight or very low birth weight infants on weight gain, serum bilirubin level and the incidence of necrotizing enterocolitis: a triple-blind randomized clinical trial
Public title
Effect of probiotic consumption versus placebo in lactating mothers with low birth weight or very low birth weight infants on weight gain, serum bilirubin level and the incidence of necrotizing enterocolitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 15 to 45 years
Mothers with low birth weight or very low birth weight infants
Exclusion criteria:
A baby who is not able to feed with breast milk
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drugs will be given in coded envelopes. Therefore, patients will be unaware of the type of intervention. The person who gives the medicine and the one who examines the patients will be different thus the physician who will examine the patients will not be aware of the intervention. The groups under study are entered in the software in coded form and analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-02-20, 1401/12/01
Ethics committee reference number
IR.UMSHA.REC.1401.1003
Health conditions studied
1
Description of health condition studied
Low birth weight
ICD-10 code
P07.0
ICD-10 code description
Extremely low birth weight newborn
Primary outcomes
1
Description
The mean weight of the newborns
Timepoint
Before the intervention and on the 14th and 28th days after the intervention
Method of measurement
Using weights
2
Description
The mean serum bilirubin level of newborns
Timepoint
Before the intervention and on the 14th and 28th days after the intervention
Method of measurement
Using a laboratory test
Secondary outcomes
1
Description
Occurrence of necrotizing enterocolitis
Timepoint
28 days after the intervention
Method of measurement
By taking history and clinical examination
Intervention groups
1
Description
Intervention group: Oral Kidilact sachet (probiotic + prebiotic) 1 gr once daily for 28 days
Category
Treatment - Drugs
2
Description
Control group: Oral placebo (starch) sachet once daily for 28 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Fatemeh Sharaflari
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sarasharaflari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Sharaflari
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sarasharaflari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Maryam Ahmadi
Position
Gynecologist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ahmadi_1011@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
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