Objectives: To investigate the effect of probiotic compared with placebo in decreasing the duration of crying in infants with colic. Design: A single blind randomized clinical trial. Setting and conduct: The eligible infants with colic referred to pediatric clinic of Kashan Shahid Beheshti Hospital will be enrolled into the trial. Inclusion criteria: Well babies aged 1-3 months, Having Wessel criteria, Birth weight more than 2500 grams, Gestational age of 37-42 weeks, 5-minute Apgar score more than 7. Exclusion criteria: Chronic gastrointestinal diseases, Immune deficiency, A history of antibiotic or probiotics therapy, Acute disease, Allergies to materials used in the study. Intervention group: Pedilact 5 drops daily for 21 days. Control group Placebo 5 drops daily for 21 days. Primary outcome: Duration of infantile crying in 24 hours before the intervention and 7th, 14th and 21th days after intervention through the recording of crying time by mother.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015031611145N16
Registration date:2015-12-05, 1394/09/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-05, 1394/09/14
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic compared with placebo in decreasing the duration of crying in infants with colic
Public title
The effect of probiotic in treatment of infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Well babies aged 1-3 months; Having Wessel criteria; Birth weight more than 2500 grams; Gestational age of 37-42 weeks; 5-minute Apgar score more than 7; Parental consent
Exclusion criteria: Chronic gastrointestinal diseases; Immune deficiency; A history of antibiotic or probiotics therapy; Acute disease; Allergies to materials used in the study; Lack of parental involvement
Age
From 1 month old to 3 months old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Contact details : Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2015-11-19, 1394/08/28
Ethics committee reference number
IR.KAUMS.REC.1394.110
Health conditions studied
1
Description of health condition studied
Infantile colic
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
Duration of infantile crying in 24 hours
Timepoint
Before the intervention and 7th, 14th and 21th days after intervention
Method of measurement
Recording of crying time by mother
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pedilact 5 drops daily for 21 days