After randomization and providing patients with the medications, mothers’ ages, body mass index (BMI), and gestational ages will be calculated and documented. The infants’ gender and feeding pattern distribution will also be documented in the first physical examination session. During a 5-month follow-up period, infants will repetitively be examined by the blinded pediatrics assistant (every two weeks by 60 days of age and every 30 days for the rest of the follow-up). Should any of the infants be diagnosed with infantile colic during the follow-up period, the assistant will document it and assess the signs of infantile colic and its severity.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Pregnant women; with the age of 18-49 years old; at last 4 weeks of pregnancy who HIV infection, renal and hepatic diseases, diabetes mellitus, and anemia are rulled out for them and absence of a history of smoking 10 or more cigarettes/day; absence of a history of using other probiotics; absence of any sign of present infection or antibiotic usage in the recent 30 days; absence of twin pregnancy
Exclusion criteria
Hypersensitivity to any components of drug, those who are being treated with anti-allergen drugs; patients unwilling to continue pregnancy or preterm labor; patients who do not receive international drug properly.
Intervention groups
Intervention to investigate the efficacy of L..Reuteri at the last month of pregnancy on prevention of infant colic in two groups of case with probiotic and control with placebo
Main outcome variables
infantile colic; severity of infantile colic
General information
Reason for update
Acronym
L. Reuteri (Lactobacillus Reuteri)
IRCT registration information
IRCT registration number:IRCT20131004014882N7
Registration date:2019-09-08, 1398/06/17
Registration timing:registered_while_recruiting
Last update:2019-09-08, 1398/06/17
Update count:0
Registration date
2019-09-08, 1398/06/17
Registrant information
Name
Fatemeh Famouri
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3663 7291
Email address
famouri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-29, 1398/06/07
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effectiveness of preinatal administration Lactobacillus Reuteri on prevention of Infantile Colic
Public title
Effect of prenatal administration of Lactobacillus Reuteri on prevention of Infantile Colic
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The last 4 weeks of pregnancy
The absence of a history of maternal immunocompromising conditions such as HIV
The absence of maternal diabetes, hepatic and renal diseases, anemia (hemoglobin less than 10), bacterial or fungal infections, twins, maternal smoking history of 10 cigarettes per day, or administration of other probiotics
Maternal age between 18 and 49 years old
All pregnant mothers who have informed consent to participate in the study.
Exclusion criteria:
Mother hypersensitivity to any component of drug
Mothers who are not willing to continue pregnancy or who have had an early pregnancy due to complications of pregnancy
Preterm labor
Mothers who do not receive the drug properly
The mothers and the pediatric assistant who will repeatedly examine the infants on account of infantile colic, are blinded from the treatment groups.
Placebo
Used
Assignment
Parallel
Other design features
Our goal is to give the pregnant mother the medicine at the end of pregnancy and its effect on the symptoms of colic in her infant after birth.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.MUI.MED.REC.1397.248
Health conditions studied
1
Description of health condition studied
Infantile colic is an “irritable/uncontrollable/compulsive/inconsolable crying” for more than 3 hours a day, at least for three days a week, and for a week or longer in an infant without any distinct cause or failure to thrive. The onset and impoverishment of the symptoms must occur under 5 months of age in order for the condition to be definite as infantile colic.
ICD-10 code
K59.9
ICD-10 code description
Functional intestinal disorder, unspecified
Primary outcomes
1
Description
The severity of colic
Timepoint
From birth to 5 months
Method of measurement
For the assessment colic severity, we used a validated Iranian questionnaire previously suggested by Famoori et al.
2
Description
infantile colic and severity
Timepoint
From birth to 5 months
Method of measurement
ِDefined by Wessel et al. and modified by ROME IV criteria as “irritable/uncontrollable/compulsive/inconsolable crying” for more than 3 hours a day, at least for three days a week, and for a week or longer in an infant without any distinct cause or failure to thrive. The onset and impoverishment of the symptoms must occur under 5 months of age in order for the condition to be definite as infantile colic.
Secondary outcomes
1
Description
prevention or reduction of severity of infantile colic
Timepoint
Birth to 5 months
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Mothers who receive probiotics:87 pregnant mother at the last 4 weeks of pregnancy enter to the study. The probiotic drug (containing 100 million live L. Reuteri from Gostaresh Milad Pharmed® Prokid™ drop). All patients were informed how and to use the medication (5 drops of the drug daily ) up to end of pregnancy.
Category
Treatment - Drugs
2
Description
Control group: placebo consumption: Control group treated with placebo drops (including sugar and carbohydrates), exactly the same as the original drug developed by Gostaresh Milad Poya Co., with 5 drops until delivery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti Hospital of Isfahan medical science
Full name of responsible person
Dr.Maryam Hajihashemi
Street address
Felezi Bridge, Motahari Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3236 7001
Fax
Email
dean@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohamadali Pourmirzaei
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Fateme Famoori
Position
associateProfessor
Latest degree
Subspecialist
Other areas of specialty/work
gastroenterology, hepatology and nutrition
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
fat.famoori@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan univercity of medical science
Full name of responsible person
Dr. Mohamadali Pourmirzaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
pourmirzaei_1347@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vida Moazeni
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
W.moazeni65@gmail.com
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