The objective of this study was to investigate the probiotic efficacy in treatment of the infantile colic compared with placebo. The 15-120 day old , breastfed Infants crying for 3 hours or more per day and 3 days or more per week entered to the study. The exclusion criteria were consumption of formula or antibiotics or finding another etiology for the infant crying. About 60 infants were randomly divided into two groups. The first group received the probiotic mixture "Protexin" one sachet daily for 30 days . The second group received the placebo one sachet daily for 30 days . We recorded the daily crying time before start of the drug and on the 7th and 30th days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205209808N1
Registration date:2013-04-20, 1392/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-20, 1392/01/31
Registrant information
Name
Aminreza Amini
Name of organization / entity
Mashhad University of Medical Sciencs, Faculty of Health Science
Country
Iran (Islamic Republic of)
Phone
+98 51 1501 9748
Email address
aminiar901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Mashhad University of Medical Sciences
Expected recruitment start date
2010-01-03, 1388/10/13
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of probiotic efficacy compared with placebo in decreasing the crying time in infants involved with infantile colic
Public title
Investigation of the effects of Probiotics on Infantile Colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Infant ; birth weight between 2 and 4 Kg ; breast mother feeding ; no drug consumption ; diagnosis of the infantile colic (keep crying for 3 hours or more per day and 3 days or more per week)
Exclusion Criteria:
Infants with age less than 15 or more than 120 days ; birth weight less than 2 or more than 4 Kg ; formula consumption ;
antibiotic consumption ; finding another cause for the infant crying
Age
To 1 year old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mshhad University of Medical Sciences
Street address
Daneshgah Street- Ghoreyshi Building
City
Mashhad
Postal code
91375-345
Approval date
2009-12-29, 1388/10/08
Ethics committee reference number
88023
Health conditions studied
1
Description of health condition studied
Iinfantiel Colics
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal painAbdominal tenderness NOS
Primary outcomes
1
Description
duration and frequency of crying
Timepoint
7 and 30 days after intervention
Method of measurement
duration of crying is measured in minute, based on questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
In the probiotic group : administration of the probiotic mixture named “protexin” orally in amount of one sachet per day for 30 days
Category
Treatment - Drugs
2
Description
In the placebo group : administration of the placebo orally in amount of one sachet per day for 30 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr. Hamidreza Kianifar
Street address
Ahmadabad Street/Qaem Hospital
City
Mashhad
2
Recruitment center
Name of recruitment center
Dr. Sheikh Hospital
Full name of responsible person
Hamid Ahanchian
Street address
Motahari Street/Dr Sheikh Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghody
Street address
Vakil Abad Blvd- Mahshad University of Medical Sciences- School of Pharmacy, Department of Pharmaceutics
City
Mashhad
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Dr. Zeinab Noorbakhsh
Position
Pediatric Assistant
Other areas of specialty/work
Street address
No31,Aref the 3rd,Ahmadabad st
City
Mashhad
Postal code
Phone
+98 51 1843 2115
Fax
Email
Noorbakhsh1362@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Hamidreza Kianifar
Position
Assistant Professor of Pediatric
Other areas of specialty/work
Street address
Ahmadabad st- Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1840 0001
Fax
Email
KianifarHR@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Zeinab Noorbakhsh
Position
Resident of Pediatrics
Other areas of specialty/work
Street address
Ahmadabad Street/Qaem Hospital
City
Mashhad
Postal code
Phone
+98 84 00001
Fax
Email
Noorbakhsh1362@gmail.com
Web page address
www.mums.ac.ir/emamreza
Sharing plan
Deidentified Individual Participant Data Set (IPD)