To evaluate the efficacy of probiotics compared with routine treatment of infantile colic 60 infants between 0 to 3 months,will be randomly assigned .First group recieved routine treatment and second group received probiotics and routine treatment.Symptoms will be evaluated by physician at baseline,second week and 4th week.The daily number of crying episodes,sleep duration,crying duratin and other clinical symptoms were assessed by a questionnaire.The questionnare filled and reported by mother,was used to evaluate the response of treatment of infantile colic symptoms
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409015330N8
Registration date:2015-11-06, 1394/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-06, 1394/08/15
Registrant information
Name
Mandana Rafeey
Name of organization / entity
Liver and gastrointestinal research center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1331 4135
Email address
rafieem@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
VICE-CHANCELLOR FOR REASEARCH OF TABRIZ UNIVERCITY OF MEDICAL SCIENCES
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of probiotics in infantile colic
Public title
Survey in efficacy of probiotics in infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :Babies with infantile colic aged 0 to 2 months
Exclusion criteria:malnutrition;using antibiotics;cow's milk protein allergy
Age
From 1 month old to 3 months old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Our study is simple sampling randomised with accidental numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of tabriz university of medical sciences
Street address
Tabriz university of medical sciences,Golgasht Av,Tabriz
City
Tabriz
Postal code
Approval date
2015-01-03, 1393/10/13
Ethics committee reference number
9431/4/5
Health conditions studied
1
Description of health condition studied
Infantile colic
ICD-10 code
k93.8
ICD-10 code description
Disorders of other specified digestive organs in diseases classified elsewhere
Primary outcomes
1
Description
Daily time crying
Timepoint
Baseline,week2,week4
Method of measurement
Mother report
2
Description
Sleep duration
Timepoint
Baseline,week2,week4
Method of measurement
Mother report
3
Description
Feeding changes
Timepoint
Baseline,week2,week4
Method of measurement
mother report
4
Description
Defication frequency
Timepoint
Baseline,week2,week4
Method of measurement
Mother report
Secondary outcomes
1
Description
Pediatric visits
Timepoint
Baseline,week2,week4
Method of measurement
Mother report
2
Description
Emergency department accesses
Timepoint
Baseline,week2,week4
Method of measurement
Mother report
3
Description
Loss of parents working days
Timepoint
Baseline,week2,week4
Method of measurement
Mother report
4
Description
Use of multiple drugs
Timepoint
Baseline,week2,week4
Method of measurement
Mother report
Intervention groups
1
Description
Interventional group received 1 sachet of supplement protexin daily and routine drugs
Category
Treatment - Drugs
2
Description
Control group recieve routine drugs for colic.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz children hospital
Full name of responsible person
Dr Mandana Rafeey
Street address
Children Hospital,Sheshgelan,Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
VICE-CHANCELLOR FOR RESEARCH OF TABRIZ UNIVERCITY OF MEDICAL SCIENCES
Full name of responsible person
Dr Mohammad reza Rashidi
Street address
Tabriz univercity of medical science
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
VICE-CHANCELLOR FOR RESEARCH OF TABRIZ UNIVERCITY 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
Tabriz university of medical sciences
Full name of responsible person
Dr Mandana Rafeey
Position
Professor
Other areas of specialty/work
Street address
Children Hospital,Sheshgelan,Tabriz
City
Tabriz
Postal code
5136735886
Phone
+98 41335262250
Fax
+98 41 3526 2280
Email
Rafeem@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz univercity of medical sciences
Full name of responsible person
Dr Mandana Rafeey
Position
Proffesor of pediatric gastroentrology
Other areas of specialty/work
Street address
Children hospital,Sheshgelan,Tabriz
City
Taabriz
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
+98 41 3526 2280
Email
mrafeey@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz univercity of medical sciences
Full name of responsible person
Farnaz Golshaeian
Position
Resident
Other areas of specialty/work
Street address
Children Hospital,Sheshgelan,Tabriz
City
Tabriz
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
+98 41 3526 2280
Email
f.golshaeian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)