Compare the effect of probiotics "(Bifidobacterium Infantis, Lactobacillus Reuteri, Lactobacillus Rhamnosus)" and placebo in the treatment of infantile colic
Infantile colic is a benign and common disorder. The disease occurs in the first 3-4 months of age. The disease presents with strong crying and irritability. This study was a randomized double-blind placebo-controlled trial. In the study, 70 Infants aged 21 days to 4 months with Wessel criteria that referred to Bahrami Children’s Hospital in Tehran, were enrolled. The main inclusion criteria include: the infants with crying at least 3 hours a day; for at least 3 days a week;
The main exclusion criteria include: the children with organic gastrointestinal disorders; consumption of any antibiotic, probiotics and formula containing probiotics and other madications for colic before entering the study;
The infantiles were randomly divided in two groups (case and control groups). The first group (case group) was given probiotic from Bifidobacterium Infantis, Lactobacillus Reuteri, and Lactobacillus Rhamnosus strain (Pedilact® brand manufactured by Iranian company, Zist Takhmir) with dose 5 drops per day orally for 4 weeks. The second group (control group) received placebo for the same period. Patients were followed up on days 7, 21 and 30 after initiation of treatment. In the follow up period these items were recorded: duration of crying, number of crying attacks per day, crying day in week and drug side effects. The purpose of the study was to evaluate the effect of probiotics in treatment of infantile colic.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120818971N4
Registration date:2016-12-27, 1395/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-27, 1395/10/07
Registrant information
Name
Kambiz Eftekhari
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7301 3000
Email address
k-eftekhari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Tehran University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of probiotics "(Bifidobacterium Infantis, Lactobacillus Reuteri, Lactobacillus Rhamnosus)" and placebo in the treatment of infantile colic
Public title
The effect of probiotics in the treatment of infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
The main inclusion criteria include: the infants with crying at least 3 hours a day; for at least 3 days a week;
The main exclusion criteria include: the children with organic gastrointestinal disorders; consumption of any antibiotic, probiotics and formula containing probiotics and other madications for colic before entering the study;
Age
From 21 days old to 4 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2016-11-13, 1395/08/23
Ethics committee reference number
IR-TUMS-MEDICINE.REC.1395.1015
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 crying
Timepoint
on days 7, 21 and 30 after initiation of treatment
Method of measurement
Questionnaire
2
Description
Crying day in week
Timepoint
on days 7, 21 and 30 after initiation of treatment
Method of measurement
Questionnaire
3
Description
Number of crying and irritability attacks per day
Timepoint
on days 7, 21 and 30 after initiation of treatment
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Vomiting
Timepoint
On days 7, 21 and 30 after initiation of treatment
Method of measurement
Questionnaire
2
Description
Constipation
Timepoint
On days 7, 21 and 30 after initiation of treatment
Method of measurement
Questionnaire
3
Description
Skin reactions
Timepoint
On days 7, 21 and 30 after initiation of treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
The first group (interventional group) was given Pedilact with dose 5 drops per day orally for 4 weeks.
Category
Treatment - Drugs
2
Description
The second group (control group) received placebo with dose 5 drops per day orally for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahrami Children's Hospital
Full name of responsible person
Kambiz Eftekhari
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhondzadeh
Street address
Tehran University of Medical Sciences
City
Tehran
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Kambiz Eftekhari
Position
Assistant professor of pediatric Gastroenterology
Other areas of specialty/work
Street address
Bahrami Children's Hospital
City
Tehran
Postal code
Phone
+98 21 7301 3210
Fax
Email
k-eftekhari@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kambiz Eftekhari
Position
Assistant professor of Pediatric Gastroenterology
Other areas of specialty/work
Street address
Bahrami Children's Hospital
City
Tehran
Postal code
Phone
+98 21 7301 3210
Fax
Email
k-eftekhari@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kambiz Eftekhari
Position
Assistant professor of Pediatric Gastroenterology
Other areas of specialty/work
Street address
Bahrami Children's Hospital
City
Tehran
Postal code
Phone
+98 21 7301 3210
Fax
Email
k-eftekhari@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)