Investigating the effect of probiotic on reducing the infantile colic
Design
This study was performed on 120 colic coliforms referred to the pediatric medical center of Tehran, randomly divided into two equal groups using randomized blocks.
The first group(A), which contains 60 infants, is given 5 drops of drop pedilact for 4 weeks (product of the zist takhmir company). The second group(B) is given 5 drops of placebo for 4 weeks (product of the zist takhmir company) . The method of selecting subjects in two groups (A and B) is completely randomized, based on blocks randomization. Demographic data including age, sex, maternal age, side effects, crying time duration, fecal consistency, before and every week after the start of the drug or placebo and the parents' satisfaction is recorded.
Settings and conduct
The place of study is the gastroenterology Clinic of the Children's Medical Center.
Participants/Inclusion and exclusion criteria
In this study, 120 full term infantile colic with birth weight greater than 2500 gram and 21 to 90 days of age who are breast fed without any underlying problem or disease, are included in the study. When taking antibiotics and probiotics by infant, or taking probiotics by mother, or getting acute and febrile illness, and ... are excluded.
Intervention groups
In this study, each of the infants in group A receive 5 drops of Pedi lact(manufactured by Zist- takhmir company) before feeding once a day for 4 weeks.
and each of infants in group B receive 5 drops of Placebo (manufactured by Zist- takhmir company) before feeding once a day for 4 weeks.
Main outcome variables
time of crying
General information
Reason for update
Acronym
The effect of probiotic on infantile colic
IRCT registration information
IRCT registration number:IRCT20151129025287N3
Registration date:2018-01-08, 1396/10/18
Registration timing:registered_while_recruiting
Last update:2018-01-08, 1396/10/18
Update count:0
Registration date
2018-01-08, 1396/10/18
Registrant information
Name
Shokufe Ahmadipour
Name of organization / entity
Lorestan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3341 1439
Email address
ahmadipour.sh@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
tehran university of medical science
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic in reducing infant colic compared to placebo
Public title
The effect of probiotic in reducing infant colic compared to placebo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of the infant 21 to 90 days
full term
birth weight> 2500 grams
breastfeed
Parental satisfaction to enter the study
Exclusion criteria:
any illness or digestive disorders
attending other clinical trials
acute illness, fever, diarrhea
Use of antibiotics or another probiotics by the infant
Probiotic use by the mother
formula feed
Age
From 21 days old to 3 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
infants are randomized (using randomized 2 blocks) to be divided into equal groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both infants' parents and doctors prescribing (drug or placebo drops) are completely unaware, but parents are told that they may randomly give the placebo drop to him/her infant
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Gharib Ave., End of Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1419733151
Approval date
2017-10-25, 1396/08/03
Ethics committee reference number
IR.TUMS.CHMC.REC.1396.3796
Health conditions studied
1
Description of health condition studied
Other and unspecified abdominal pain
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
crying hours
Timepoint
weekly
Method of measurement
Questionnaire
Secondary outcomes
1
Description
stool Consistency
Timepoint
weekly
Method of measurement
Questionnaire
Intervention groups
1
Description
In the intervention group, 5 drops of pediatric drops (made by zist- takhmir company) is given daily for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: 5 drops of placebo drops (made by the zist- takhmir company) is given daily for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Shokoufeh Ahmadipour
Street address
Children's Medical Center., Gharib Ave., End of Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2014
Email
ahmadipour_sh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Children's Medical Center., Gharib Ave., End of Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2014
Email
ahmadipour_sh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shokoufeh Ahmadipour
Position
Fellow of Pediatric's Gastroenterology
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center., Gharib Ave., End of Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2014
Fax
Email
ahmadipour_sh@yahooo.co
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Gholam hosein Fallahi
Position
Professor, Pediatric's Gastroenterologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center., Gharib Ave., End of Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2014
Fax
Email
dr.ghfallahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shokoufeh Ahmadipour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center., Gharib Ave., End of Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2014
Fax
Email
ahmadipour_sh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Some of the data, such as information on the main outcome, can be shared.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academia and scientific departments
Under which criteria data/document could be used
Understanding Data Analysis Method
From where data/document is obtainable
E-mail
What processes are involved for a request to access data/document
Through email with correspondence and providing a code of ethics certificate from his/her university