Evaluation of the effect of diet with or without probiotic on the breastfeed infants proctocolitis
Design
Randomized parallel group trial; double blinded, on 30 patients; randomization is done bye random number table
Settings and conduct
In this randomized double blinded clinical trial, newborns aging to 12 months with caws milk protein allergy that referred to pediatric center of Tehran University of Medical Science will be evaluated. 30 patients will be divided to test and control groups by random number tables. In all patients all of caw milk products will be inhibited. Calcium supplement and vitamin D would prescribed for mothers. The test group would be prescribed with probiotic containing lactobacilous ramnozous. The control group would be prescribed with placebo for 4 weeks. Clinical symptoms including irritability, number of defecation in every week, mocoid in stool, blood in stool, time of pain in a week, would be evaluated for 4 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of newborn to 12 months; caw milk protein allergy; breast feed
Exclusion criteria: taking probiotic and prebiotic in the last two months; taking antibiotic in the last two weeks; systemic infection
Intervention groups
Test group: taking probiotic
Control group: taking water
Main outcome variables
Elimination of clinical symptoms of allergy; negative white blood cells in stool
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210817052216N1
Registration date:2021-10-02, 1400/07/10
Registration timing:registered_while_recruiting
Last update:2021-10-02, 1400/07/10
Update count:0
Registration date
2021-10-02, 1400/07/10
Registrant information
Name
Shivasadat Khalifehsoltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8839 0538
Email address
shiva.khalifeh.ped@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation and comparison of the effect of diet with or without probiotic on the breastfeed infants proctocolitis
Public title
effect of probiotic on inflammatory diarrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age newborn to 12 months
cow milk protein allergy
breast fed
Exclusion criteria:
taking probiotic/prebiotic in last two months
taking antibiotic in the last two weeks
existing systemic infection in clinical examination
positive stool culture
fever disease
hirschsprung
coagulopathy
systemic disease
formula fed
Age
From 5 days old to 12 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this research we will use simple randomization by random number table to assign patients to test and control groups. To avoid disparity between group sizes, we will use replacement
randomization. If the disparity exceeded the preset criterion of 3, we will generate another randomization list using simple randomization until we achieve a balanced group size. Randomization would be concealed using sequentially numbered, sealed, opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The A bottle contain probiotic and the B bottle contains water. The bottles are completely similar and would be given to the clinician. He/she and also the statistic analyzer does not know the relation between the alphabet and the content of bottles.
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 Science
Street address
No. 7, Gharib Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1414744978
Approval date
2020-07-27, 1399/05/06
Ethics committee reference number
IR.TUMS.CHMC.REC.1399.094
Health conditions studied
1
Description of health condition studied
Caws milk protein allergy
ICD-10 code
Z91.011
ICD-10 code description
Allergy to milk products
Primary outcomes
1
Description
Elimination of clinical symptoms of allergy; negative white blood cells in stool
Timepoint
Evaluation of stool WBC in the start and after 4 weeks
Method of measurement
Stool Exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: probiotic droplet containing lactobacillus ramnosous. Every 5 droplet conatins 5*10*8 cells of lipofilized lactobacillus ramnosous that would be prescribed for 1 month.
Category
Treatment - Drugs
2
Description
Control group: 5 droplet of distilled water would be prescribed daily for 1 month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric center of Tehran University of Medical Science
Full name of responsible person
Shivaasadat Khalifehsoltani
Street address
No. 7, Gharib Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1414744978
Phone
+98 21 8839 0538
Email
shiva.khalifeh.ped@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shivaasadat Khalifehsoltani
Street address
No. 7, Gharib Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1414744978
Phone
+98 21 8839 0538
Email
shiva.khalifeh.ped@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shivasadat Khalifehsoltani
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
Gastroinestinology
Street address
No 7, East lal St., Hashtbehesht St., Fatemi St.
City
Tehran
Province
Tehran
Postal code
1414744978
Phone
+98 21 8839 0538
Fax
Email
shiva.khalifeh.ped@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shivasadat Khalifehsoltani
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
General Practitioner
Street address
No 7, East lal St., Hashtbehesht St., Fatemi St.
City
Tehran
Province
Tehran
Postal code
1414744978
Phone
+98 21 8839 0538
Fax
Email
shiva.khalifeh.ped@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shivasadat Khalifehsoltani
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
General Practitioner
Street address
No 7, East lal St., Hashtbehesht St., Fatemi St.
City
Tehran
Province
Tehran
Postal code
1414744978
Phone
+98 21 8839 0538
Fax
Email
shiva.khalifeh.ped@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available