The aim of this study is to assess the effect of Lactobacillus rhamnosus in treatment of patients with allergic proctocolitis.
Design
Clinical trial with control group, with parallel group, double blinded, phase 3 investigation of 20 patients. Randomised using the RAND function of Microsoft Excel.
Settings and conduct
This multi-center trial will be performed involve 1 to 24 month-old infants diagnosed with allergic proctocolitis. Patients will be randomly divided in to two groups. Infants in both groups will receive elimination of allergen from diet. Infants in the control group will receive placebo and infants in the intervention group willreceive probiotic Lactobacillus rhamnosus .
Participants/Inclusion and exclusion criteria
Infants between the ages of 1 to 24 months, diagnosed with allergic proctocolitis (visible or occult blood in stool) from Bahrami Pediatric Hospital and The Medical Center for Children Hospital, will be enrolled to the study.
Infants between the ages of 1 to 24 months, diagnosed with bacterial gastroenteritis and patients who have already used probiotics will be excluded from participation .
Lack of consent from parents of the infant will result in exclusion.
Intervention groups
The standard treatment for allergic proctocolitis , in form of dietry exclusion of the allergen from the mother and the subject`s diet , will be undertaken in all participants .
In the control group placebo, and in the treatment group Lactobacillus rhamnosus will be administered.
Main outcome variables
Elimination of blood, visible or occult, from the patient's stools.
General information
Reason for update
Acronym
CMPA
IRCT registration information
IRCT registration number:IRCT20140830018971N6
Registration date:2021-02-01, 1399/11/13
Registration timing:prospective
Last update:2021-02-01, 1399/11/13
Update count:0
Registration date
2021-02-01, 1399/11/13
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
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effect of Lactobacillus rhamnosus on the clinical course of infants with allergic proctocolitis .
Public title
The effect of probiotics on cow milk allergy .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants between the ages of 1 to 24 months diagnosed with allergic proctocolitis because of hematochezia.
Infants between the ages of 1 to 24 months diagnosed with allergic proctocolitis because of occult blood.
Exclusion criteria:
Infants diagnosed with lactose malabsorbtion.
Infants diagnosed with bacterial gasrtoenteritis.
Infants treated with probiotics.
Age
From 1 month old to 24 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Using randomised size 4 and 2 allele blocks ,the subjects will be divided in to group A placebo and group B treatment .
The below model will be used to distinguish each group: AABB-ABBA-ABABA-BBAA-BABA-BAAB,…..
Blinding (investigator's opinion)
Double blinded
Blinding description
Since the subjects of the study are infants, they will not be aware of the type therapy randomised to them .
Furthermore, the investigators will be blinded to the randomisation process.
Thus, making this a double-blinded study.
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
Ansaralhussein Ave., Kiaee Ave., Damavand Ave.
City
Tehran
Province
Tehran
Postal code
4499116417
Approval date
2021-01-21, 1399/11/02
Ethics committee reference number
IR.TUMS.CHMC.REC.1399.187
Health conditions studied
1
Description of health condition studied
Infantile allergic proctocolitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Visible or occult blood in the stool.
Timepoint
Day 5 and 14 from start of the treatment.
Method of measurement
Stool results.
Secondary outcomes
empty
Intervention groups
1
Description
The intervetion group will receives 10 drops of Ramnoflor solution orally a day for 8 weeks, containing LGG 5*10^10 , from Farabiotic Pharmaceuticals in Iran; the control group will receive placebo without LGG.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahrami hospital
Full name of responsible person
faeze ghanaati
Street address
Ansaralhussein Ave., Kiaee Ave., Damavand Ave
City
Tehran
Province
Tehran
Postal code
4499116417
Phone
+98 21 7759 2300
Email
faezeghanaati@gmail.com
2
Recruitment center
Name of recruitment center
Children`s medical center
Full name of responsible person
faeze ghanaati
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
faezeghanaati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
faeze ghanaati
Street address
Ansaralhussein Ave., Kiaee Ave., Damavand Ave
City
Tehran
Province
Tehran
Postal code
4499116417
Phone
+98 21 7759 2300
Email
faezeghanaati@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Faeze Ghanaati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ansaralhussein Ave., Kiaee Ave., Damavand Ave
City
Tehran
Province
Tehran
Postal code
4499116417
Phone
+98 21 7759 2300
Email
faezeghanaati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
faeze ghanaati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ansaralhussein Ave., Kiaee Ave., Damavand Ave
City
Tehran
Province
Tehran
Postal code
4499116417
Phone
+98 21 7759 2300
Email
faezeghanaati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
faeze ghanaati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ansaralhussein Ave., Kiaee Ave., Damavand Ave
City
Tehran
Province
Tehran
Postal code
4499116417
Phone
+98 21 7759 2300
Email
faezeghanaati@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