In a randomized, double-blind, placebo-controlled study,thirty two breastfed infants aged 1 months to 12 months with cow`s milk protein allergy will be enrolled in randomised control trial in which they receive lactobacillus GG or placebo for one month. Clinical symptoms of gastrointestinal function (vomiting, colic, rectal bleeding and diarrhea), and baseline characteristics (head circumference, body length and weight) will recorded at the beginning, the end of first and third months of treatment .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301314976N2
Registration date:2013-05-07, 1392/02/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-07, 1392/02/17
Registrant information
Name
Hamid Ahanchian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2469
Email address
ahanchianh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2010-01-03, 1388/10/13
Expected recruitment end date
2011-03-04, 1389/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lactobacillus GG on gastrointestinal symptoms of infants with cow`s milk protein allergy
Public title
A new symbiotic may improve weight gain in infants with cow’s milk allergy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-12 months-old infants with the clinical symptoms of cow's milk protein allergy including rectal bleeding, diarrhea, vomiting and evidences of colitis; a good general condition, breast milk feeding and cow's milk consuming mother.
The infants are excluded from the study if they had a known immune deficiency, gastro intestinal disease, positive stool culture, coagulopathy or are receiving any type of antibiotic therapy.
Age
To 1 year old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences Ethics Committee
Street address
Ghoreish bulding, Daneshgah street
City
Mashhad
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
87357
Health conditions studied
1
Description of health condition studied
Cow milk protein allergy
ICD-10 code
K90.4
ICD-10 code description
Malabsorption due to intolerance to: carbohydrate-fat-protein-starch
Primary outcomes
1
Description
Severity of gastrointestinal symptoms
Timepoint
At the beginning of the study, 3 months after intervention
Method of measurement
The number of vomiting, colic, rectal bleeding and diarrhea
Secondary outcomes
1
Description
weight
Timepoint
At the beginning of the study, 3 months after intervention
Method of measurement
Gram
2
Description
head circumference
Timepoint
At the beginning of the study, 3 months after intervention
Method of measurement
centimeter
3
Description
body length
Timepoint
At the beginning of the study, 3 months after intervention
Method of measurement
centimeter
Intervention groups
1
Description
The control group received placebo without probiotics which are match for size, shape, and volume of contents and manufactured by the same company, daily for 4 weeks
Category
Placebo
2
Description
The study group will receive a synbiotic containing 1 billion Colony Forming Units (CFU) of ProtexinR Restore: a mixture of Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis, Lactobacillus bulgaricus and FOS (Protexin healthcare, Somerset, United Kingdom), in the form of freeze dried powder will administer daily for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Dr Hamid Ahanchian
Street address
Pediatric Allergy department, Ghaem hospital, Ahmad Abad Blvd, Mashhad, Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Associate Professor Mohsen Tafaghodi
Street address
Ghoreishi bulding, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghaem hospital
Full name of responsible person
Hamid Ahanchian
Position
Assistant professor
Other areas of specialty/work
Street address
Ghaem hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2522
Fax
Email
Ahanchianh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ghaem hospital
Full name of responsible person
Hamid Ahanchian
Position
Assistant professor
Other areas of specialty/work
Street address
Ghaem hospital, Ahmad abad blvd
City
Mashhad
Postal code
Phone
Fax
Email
ahanchianh@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)