The comparison of the efficacy of a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus” with dimeticone drop in the treatment of infantile colic
A therapeutic goal including :"Comparing the efficacy of a synbiotic drop with dimeticone drop in the treatment of infantile colic".
Design
Design: A randomized tripple blind clinical trial
Settings and conduct
Participants: 70 infants with inclusion criteria of the new Rome IV for diagnosis of infantile colic, refering to Bahrami Hospital.
Setting and conduct:The infants will be randomly assigned into two groups. Each group containes 35 infants.
Intervention: Infants in group A will receive nonpharmacological treatment + Pedilact drop(containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”); 5 drops every 6 hours and Infants in group B will receive nonpharmacological treatment + dimeticone drop ; 7-10 drops every 6 hours.
Length of Intervention:The rate of clinical manifestations and side effects of each drug will be recordedon the 7th and 30th day after intervention.The data will be recorded in seperate questioners for each infant and then will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Breast-fed infants under 5 months of age fulfilling the new Rome IV criteria for diagnosis of infantile colic.
Exclusion criteria: 1-any acute or chronic diseases, especially GI tract problems 2- Recieving antibiotics or supplements containing probiotics or prebiotics 1 week prior to the study 3- Parents' unwilling to participate in the study4-Protein milk allergic cases
Intervention groups
1-Group A intervention: They will recieve nonpharmacological treatment + a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”.
2-Group B intervention: They will recieve nonpharmacological treatment + "dimeticone drop”
Main outcome variables
Recovery rate of clinical manifestations of infantile colic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160827029535N6
Registration date:2019-09-13, 1398/06/22
Registration timing:prospective
Last update:2019-09-13, 1398/06/22
Update count:0
Registration date
2019-09-13, 1398/06/22
Registrant information
Name
Peymaneh Alizadeh Taheri
Name of organization / entity
Tehran University of Medical Sciences, Bahrami Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 7301 3420
Email address
alizadep@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the efficacy of a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus” with dimeticone drop in the treatment of infantile colic
Public title
The comparison of the efficacy of a synbiotic drop with dimeticone drop in the treatment of infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Any healthy infant
Under 5 months of age
Diagnosed as colic according to the new Rome IV criteria
Exclusion criteria:
Any acute or chronic diseases, especially GI tract conditions
Taking antibiotics or supplements of probiotics or prebiotics since 1 week prior to the study
Not fulfilling the new Rome IV criteria
Parents' unwilling to participate in the study.
Protein milk allergy
Age
To 5 months old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
35
Any healthy infant under 5 months of age with the diagnosis of colic according to the new Rome IV criteria who has not received antibiotics or supplements of probiotics or prebiotics since1 week prior to the study
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The caregivers who administeres the drug, the researcher who completes the questionnaires and collected the data, and the statistician who analyzed the data are blinded throughout the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran university Of Medical Sciences, Pursina Street, Ghods Avenue, Enghelab Square
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2019-05-31, 1398/03/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.139
Health conditions studied
1
Description of health condition studied
Infantile colic
ICD-10 code
K52.3
ICD-10 code description
Indeterminate colitis
Primary outcomes
1
Description
Recovery rate of infantile colic symptoms and signs
Timepoint
One week and one month after beginning of intervention
Method of measurement
Questionnaire
2
Description
Complications of each drug during intervention
Timepoint
One week and one month after beginning of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Recovery rate of infantile colic symptoms and signs
Timepoint
One week one month after beginning of intervention
Method of measurement
Questionnaire
2
Description
Complications of each drug ( diarrhea, vomiting and skin rush) during intervention
Timepoint
One week and one month after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Group A intervention: They will recieve nonpharmacological treatment +a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”Intervention group:
Category
Treatment - Drugs
2
Description
Group A intervention: They will recieve nonpharmacological treatment +Dimeticon drop