Protocol summary

Summary
This clinical trial was carried out to assess the effects of probiotics in the treatment of infantile colic in 84 breast fed and formula fed infants that have age less than 13 weeks who referred to Arak AmirKabir hospital Based on inclusion criteria: infantile colic (crying and restlessness more than 3 hours a day for more than 3 days a week); age less than 3 months, more than 36 weeks gestational age at birth, birth weight greater than 2500 g and Exclusion criteria: growth retardation, medical problems( immune compromise, genetic disorders) or taking solids, antibiotics or kidilact. Children were Randomly assigned in two groups, case groups: (treated with 5 drops once daily dose of probiotic Pedilact and voice and vocal technique recommended to reduce colic include: rhythmic rocking motion, walking, mild tremor, etc.) and the control group (only recommend techniques for reducing colic), respectively. Clinical improvement of infants was assessed within 28 days after start of intervention. Outcome variables were crying attacks, restlessness, and crying time in infants within 24 hours.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111023876N3
Registration date: 2017-03-11, 1395/12/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-11, 1395/12/21
Registrant information
Name
Fatemeh Dorreh
Name of organization / entity
Arak University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 86334172517
Email address
doreh.f@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-06-24, 1394/04/03
Expected recruitment end date
2015-12-24, 1394/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic in treatment of infantile colic in children
Public title
The effect of probiotic in treatment of infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: infantile colic (crying and restlessness more than 3 hours a day for more than 3 days per week); age < 3 months, more than 36 weeks gestational age at birth, birth weight greater than 2500 g Exclusion criteria: growth retardation , medical problems (immune compromise genetic disorders or significant growth retardation), taking solids, antibiotics or kidilact
Age
To 3 months old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
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 the Arak University of Medical Sciences
Street address
Arak, Street Rahe Ahan,Alley Maskan
City
Arak
Postal code
Approval date
2013-05-22, 1392/03/01
Ethics committee reference number
15-152-92

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
The number of episodes of crying
Timepoint
24 hours on days 7, 14, 21 and 28
Method of measurement
questionnaire

Secondary outcomes

1

Description
Crying time
Timepoint
24 hours on days 7, 14, 21 and 28
Method of measurement
questionnaire

Intervention groups

1

Description
Case Groups:  5 drops once daily probiotic drug treatment Pdylakt for 28 days and recommended technique for reducing colic, including voice and singing soothing, rhythmic rocking motion, walking, mild tremor and ...
Category
Treatment - Drugs

2

Description
Control group : only recommend techniques for reducing colic, including voice and singing soothing, rhythmic rocking motion, walking, mild tremor and ...
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak AmirKabir Hospital
Full name of responsible person
Dr. Fatemeh Dorreh
Street address
Arak, Street RahAhan, Amir Kabir Hospital
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiee
Street address
School of Medicine
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Arak 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
Arak University of Medical sciences
Full name of responsible person
Dr. Fatemeh Dorreh
Position
Pediatrician
Other areas of specialty/work
Street address
Arak Amirkabir Hospital
City
Arak
Postal code
Phone
+98 86 3313 5075
Fax
Email
Dorreh.f@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Dorreh
Position
Pediatrician
Other areas of specialty/work
Street address
Arak Amirkabir Hospital
City
Arak
Postal code
Phone
+98 86 3313 5075
Fax
Email
dorreh.f@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Dorreh
Position
Pediatrician
Other areas of specialty/work
Street address
Arak Amirkabir Hospital
City
Arak
Postal code
Phone
+98 86 3313 5075
Fax
Email
Dorreh.f@arakmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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