The comparison of the efficacy of a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus” with a synbiotic containing “Bifidobacterium lactis” in the treatment of infantile colic
Comparing the efficacy of two synbiotics in the treatment of infantile colic
Design
A randomized double blind clinical trial with simple randomization at the individual level and using table of random numbers; allocation concealment by sequentially numbered sealed opaque envelop. Infants in group A will receive Pedilact (containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”) and Infants in group B will receive BB care (containing “Bifidobacterium lactis”).Both groups will receive 5 drops of each drug every 6 hours for one month.
Settings and conduct
The neonates with clinical GERD will be randomly assigned into two groups each containing 35 ones in Bahrami hospital. Infants in group A will receive Pedilact (containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”) and Infants in group B will receive BB care (containing “Bifidobacterium lactis”).Both groups will receive 5 drops of each drug every 6 hours.The participants; physicians, nurses and mothers who care the participants; the researcher who collect the data and the person who analyses the data are blind to the study. Zist-Takhmir company has produces both synbiotics as BB care drop with two different red and yellow lables .Nobody knows about the content of the bottles except the main researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Breast feeding infants of 3 weeks to 3 months of age fulfilling the Wessel’s criteria including: crying for at least 3 hours per day, for at least 3 days per week, and for at least 3 weeks from birth to 3-4 months of age or having characteristic clinical manifestations of colic including irritability, crying ,flushing and passage of a large amount of bowel gas along with defecation; irritability and crying especially in the evening and increased bowel sounds in auscultation 3-No apparent cause or failure to thrive ;
Exclusion criteria:
1-Having any diseases, especially GI tract ones 2-Receiving any other drugs at the time of the study except multivitamins.
Intervention groups
In group A Pedilact (containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”) will be administered as 5 drops QID and
In group B BB care (containing “Bifidobacterium lactis”) will be administered as 5 drops QID for one month..
Main outcome variables
1-The rate of clinical response to each symbiotic.
2-The occurrence rate of side effects of each symbiotic.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160827029535N4
Registration date:2018-02-07, 1396/11/18
Registration timing:prospective
Last update:2018-02-07, 1396/11/18
Update count:0
Registration date
2018-02-07, 1396/11/18
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
Invstigator
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2019-04-19, 1398/01/30
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 a synbiotic containing “Bifidobacterium lactis” in the treatment of infantile colic
Public title
The Comparison of two synbiotics in the treatment of infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-Breast-fed infants with the age of 3 weeks to 3 months 2- Fulfilling the Wessel’s criteria including: crying for at least 3 hours per day, for at least 3 days per week, and for at least 3 weeks from birth to 3-4 months of age or the characteristic clinical manifestations of colic including irritability, crying ,flushing and passage of a large amount of bowel gas along with defecation; irritability and crying especially in the evening and increased bowel sounds in auscultation 3-No failure to thrive .
Exclusion criteria:
1-any acute or chronic diseases, especially GI tract conditions
2- use of medications except routine supplements
Age
From 21 days old to 4 months old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization at the individual level and using table of random numbers; allocation concealment by sequentially numbered sealed opaque envelop
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants; physicians, nurses and mothers who care the participants; the researcher who collect the data and the person who analyses the data are blind to the study.Zist-Takhmir company has produces both synbiotics as BB care drop with two different red and yellow lables .Nobody knows about the content of the bottles except the main researcher.
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 Tehran Tehran Iran, Islamic Republic Of Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-08-06, 1396/05/15
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.3058
Health conditions studied
1
Description of health condition studied
Infantile colic
ICD-10 code
R 10.4
ICD-10 code description
Abdominal pain
Primary outcomes
1
Description
Response rate of infantile colic symptoms and signs
Timepoint
Before intervention, one week and one month after beginning of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Complications of each synbiotic during intervention including vomiting, constipation, skin reactions and infections.
Timepoint
Before intervention,one week and one month after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Group A intervention: Administrating a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”. Zist-Takhmir company has produces this drop as BB care drop with red lable for the present search study.It is administered 5 drop every 6 hours for one month.
Category
Treatment - Drugs
2
Description
Intervention group: Group B intervention: Administrating a synbiotic containing “Bifidobacterium lactis”. Zist-Takhmir company has produces this drop as BB care drop with yellow label for the present search study. It is administered 5 drop every 6 hours for one month.