The comparison of the efficacy of a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”(Pedilact drop) with a synbiotic containing “Bifidobacterium lactis"(BB care drop) in the treatment of infantile functional constipation
A therapeutic goal including :"Comparing the efficacy of Pedilact drop with BBcare drop in the treatment of infantile functional constipation".
Design
A randomized double blind clinical trial
Settings and conduct
80 infants will be randomly assigned into two groups of 40 infants.
Group A will receive nonpharmacological treatment + Pedilact drop ; 5 drops QID.Group B will receive nonpharmacological treatment + BBcare drop ; 5 drops QID for 30 days.
The data will be recorded in seperate questioners for each infant and then will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infants under1 year of age who have at least 2 characteristics of the following chriteria for 1 month :
1. Two or fewer defecations per week 2.History of excessive stool retention 3. History of painful or hard bowel movements 4. History of large-diameter stools 5. Presence of a large fecal mass in the rectum.
Exclusion criteria : GI Obstraction or surgery ; Recieving opiates, muscle relaxants and sedatives ; Mechanical ventilation; Underlying diseases, Central and Pripheral nervous system abnormalities, ; Irritable bowel syndrome ;Endocrine Diseases( Hypothyroidism) ; anorectal abnormalities; recieving probiotics products since one week before intervention.
Intervention groups
Group A intervention: They will recieve nonpharmacological treatment +a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”(Pedilact drop)
Group B intervention: They will recieve nonpharmacological treatment +a synbiotic containing “Bifidobacterium Lactis"(BBcare drop)
Main outcome variables
Response rate of clinical manifestations of infantile constipation to each synbiotic in each group
General information
Reason for update
Acronym
درمان یبوست شیرخواران
IRCT registration information
IRCT registration number:IRCT20160827029535N7
Registration date:2020-02-22, 1398/12/03
Registration timing:registered_while_recruiting
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
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
2020-02-09, 1398/11/20
Expected recruitment end date
2020-07-20, 1399/04/30
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”(Pedilact drop) with a synbiotic containing “Bifidobacterium lactis"(BB care drop) in the treatment of infantile functional constipation
Public title
The comparison of the efficacy of two different synbiotics in the treatment of infantile functional constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Must include 1 month of at least 2 of the following in infants up to 4 years of age:1.Two or fewer defecations per week 2.History of excessive stool retention 3. History of painful or hard bowel movements 4. History of large-diameter stools 5. Presence of a large fecal mass in the rectum
Exclusion criteria:
GI Obstraction or previous GI surgery ; Recieving opiates, muscle relaxants and sedatives ; Mechanical ventilation; Underlying diseases, Central and Pripheral nervous system diseases ; Irritable bowel syndrome ;Endocrine Diseases( Hypothyroidism) ; anorectal abnormalities; recieving probiotics products since one week before intervention
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization at the individual level and using random number table with allocation concealment by sequentially numbered sealed opaque envelop
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
Ethics committee of 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
2019-12-10, 1398/09/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.644
Health conditions studied
1
Description of health condition studied
Infantie functional constipation
ICD-10 code
k59.0
ICD-10 code description
Other diseases of intestines
Primary outcomes
1
Description
Response rate of clinical manifestations of infantile constipation to each synbiotic in each group
Timepoint
One week and one month after beginning of intervention
Method of measurement
Questionnaire according to the new Rome IV criteria
Secondary outcomes
1
Description
Complications of each drug ( diarrhea, vomiting and skin rush) during intervention
Timepoint
One week and one month after intervention
Method of measurement
Questionnaire according to the occurance of diarrhea, vomiting and skin rush
Intervention groups
1
Description
Group A intervention: They will recieve nonpharmacological treatment +a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”(Pedilact drop)
Category
Treatment - Drugs
2
Description
Group B intervention: They will recieve nonpharmacological treatment +a synbiotic containing “Bifidobacterium Lactis ”(BB care drop)