Infantile colic is one of the most parental complaints in the first few months of life and sometimes it causes anxiety in family. As the pathophysiology of colic has been not known hence there is no efficient way for therapy. New researches have shown that changes in the micro flora can be revealed the symptoms of colic. The aim of this study is the effect of probiotic Lactobacillus Reuteri on the time of fuss and crying in colicky infant.
At least 30 infants in the single-blind trial, the inclusion criteria (infants 15 to 60 days...) and exclusion (of milk...) are selected. Then for 5 to 7 days five drops of placebo with label no.1 will be tried. We call the parents twice a day and check for the restlessness times. Then the drug with label no.2 (Bio Gaia drop that contains American type culture collection strain 55730 Lactobacillus Reuteri) will be started with 5 drops daily for two weeks. The mean of restlessness times before and after therapy will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012713489N2
Registration date:2014-07-04, 1393/04/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-04, 1393/04/13
Registrant information
Name
Zahra Akbarian Rad
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8284
Email address
z.akbarian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Babol University of Medical Sciences.
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness of probiotic Lactobacillus reuteri and Placebo in reducing the time of restlessness in infants with infantile colic
Public title
Effect of probiotic in infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Restless infants 15 to 60 days of age;With birth weight greater than 2500 g; Breast feeding; No signs or symptoms of chronic disease in history and initial examination; Normal urine analysis; Based on the criteria crying and agitation vessels at least 3 hours a day and more than 3 days a week
Exclusion criteria:
Use dry milk; use of antibiotics; Taking painkillers or carminative; chronic illnesses in infants
Age
From 15 days old to 2 months old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
At first drug and placebo will be prepared by physician’s assistant in similar vials and will be named with the labels 1 and 2. Physicians will give the drug and the placebo to patient. During 5-7 days, assistant calls the parents twice a day. Then we start with label 2 and record times of restlessness.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences.
Street address
Keshavarz street, Babol University of Medical Sciences
City
Babol
Postal code
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
2306/30/ژ/پ
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
Restlessness Times
Timepoint
Intervention every day starting two weeks after the intervention
Method of measurement
clinical
Secondary outcomes
empty
Intervention groups
1
Description
Probiotic Lactobacillus reuteri (American Type culture collection Strain 55730) produced by BioGaia company 5 drops orally,every days. until the day 14 of treatment.
Category
Treatment - Drugs
2
Description
Placebo,(distilled water) 5 drops orally every day for 5-7 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Aiatollah Rohani Hospital
Full name of responsible person
Yalda Taghipour
Street address
Ganjafroz street, Aiatollah Rohani Hospital
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Babol University of Medical Sciences
Full name of responsible person
Amrollah Mostafazadeh
Street address
Ganjafroz street, Babol University of Medical Sciences
City
Babol
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,Babol 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
Babol University of Medical Sciences
Full name of responsible person
Zahra Akbarian Rad
Position
Assistant professor/ Neonatologist
Other areas of specialty/work
Street address
Ganjafroz street, Aiatollah Rohani Hospital
City
Babol
Postal code
Phone
+98 11 1223 8284
Fax
Email
zhr_akbarian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zahra Akbarian Rad
Position
Assistant professor/ Neonatologist
Other areas of specialty/work
Street address
Aiatollah Rohani Hospital
City
Babol
Postal code
Phone
+98 11 1223 8284
Fax
Email
zhr_akbarian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zahra Akbarian Rad
Position
Resident of Pediatrics
Other areas of specialty/work
Street address
Ganjafroz street, Aiatollah Rohani Hospital
City
Babol
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)