Comparison of the reduction of infant colic symptoms following casein-free diet in children with and without a history of parental atopy
Design
Non-randomized clinical trial, with parallel groups, without blinding, without control group, phase 3 on 206 patients.
Settings and conduct
All infants suffering from colic referred to Amirkabir Hospital in Arak will be included in the study. Parents of infants will be examined by an asthma and allergy specialist and any evidence of atopy including asthma, atopic dermatitis and allergic rhinitis will be reported by him. Patients will be divided into two groups with atopy and without atopy. Then, babies in both groups will be subjected to a casein-free diet (removing dairy products from the mother's diet) for one month. Blinding will not be done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 15 months to 3 months, suffering from infantile colic. Exclusion criteria: lack of parental consent.
Intervention groups
In the first intervention group, 103 breastfed children who have a history of atopy in their parents and are referred for the treatment of infantile colic are subjected to a casein-free diet (removing dairy products from the mother's diet) for one month. In the second intervention group, 103 breastfed children who have no history of atopy in their parents and are referred for the treatment of infantile colic are subjected to a casein-free diet (removal of dairy products from the mother's diet) for one month. Except for the casein-free diet, the rest of the treatment recommendations will be the same between people.
Main outcome variables
The general conditions of babies based on the mother's understanding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200702047986N2
Registration date:2023-04-26, 1402/02/06
Registration timing:prospective
Last update:2023-04-26, 1402/02/06
Update count:0
Registration date
2023-04-26, 1402/02/06
Registrant information
Name
Davoud Shabani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 3149
Email address
davoud9372@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the reduction of infant colic symptoms following casein-free diet in children with and without a history of parental atopy
Public title
Comparison of the reduction of infant colic symptoms following casein-free die
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15 days to 3 months
Having infantile colic
Exclusion criteria:
Lack of parental consent
Age
From 15 days old to 3 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
206
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Payambar-e-azam complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2023-01-22, 1401/11/02
Ethics committee reference number
IR.ARAKMU.REC.1401.327
Health conditions studied
1
Description of health condition studied
Infant colic
ICD-10 code
R10.83
ICD-10 code description
Colic
Primary outcomes
1
Description
The general conditions of babies based on the mother's understanding
Timepoint
Before the start of the intervention and one month after the start of the intervention
Method of measurement
Through a questionnaire that is filled by the mother
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: We put 103 breastfed children who have a history of atopy in their parents and referred for the treatment of infant colic under a casein-free diet (removing dairy products from the mother's diet) for one month. Except for the casein-free diet, the rest of the treatment recommendations will be the same between people.
Category
Treatment - Other
2
Description
Intervention group 2: We put 103 breastfed children who have no history of atopy in their parents and referred for the treatment of infant colic under a casein-free diet (removing dairy products from the mother's diet) for one month. Except for the casein-free diet, the rest of the treatment recommendations will be the same between people.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Roghayeh Ostadi
Street address
Shahid Shiroudi St., Parastar Sq.
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4715
Email
amirkabir-hospital@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahdi Salehi
Street address
Payambar-e-azam complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Roghayeh Ostadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
6341738481
Phone
+98 86 3417 3520
Email
Ostadi.r.m97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Roghayeh Ostadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
6341738481
Phone
+98 86 3417 3520
Email
Ostadi.r.m97@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Roghayeh Ostadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
6341738481
Phone
+98 86 3417 3520
Email
Ostadi.r.m97@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