Protocol summary

Summary
In this randomized, single-blind clinical trial, infants younger than year with allergy to cow's milk protein referred to pediatric gastroenterology clinic of Bouali Sina Hospital of Sari are evaluated. In case of consuming probiotics and prebiotics within 2 months and receiving antibiotics within 2 weeks patients are excluded. Patients are randomly divided into two intervention and control groups with table of random numbers. Limitation of dairy cattle consumption for mother and infants are applied. For the intervention group, in addition to diet protocol, one sachet Protexin probiotic made by Health care co. is administered daily for 4 weeks and the control group receives the same package containing Aptamil Pepti Junior formula one sachet per day for 4 weeks. At the beginning of the study, stool cultured and analysis and fecal calprotectin are performed for all patients and then at second, 4th, 8th, 12th and 16th week, WBC and RBC level and occult blood and fecal calprotectin are measured. At 4th and 16th week, stool culture is done to determine the intestinal flora. During the first 16 weeks of the treatment, the number of stools per week, mucoid stools per week, number of stool bleeding in week, pain in week are recorded and compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017043033595N2
Registration date: 2017-07-02, 1396/04/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-02, 1396/04/11
Registrant information
Name
Hassan Karami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2334
Email address
hakarami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and Technology of Mazandaran University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-12-20, 1396/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the therapeutic effect of probiotics in children with allergy to cow's milk protein
Public title
The therapeutic effect of probiotics in children with allergy to cow's milk protein
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 1-12 months; cow's milk allergy Exclusion criteria: consuming probiotics and prebiotics within 2 months, receiving antibiotics within 2 weeks, evidence of systemic infection on physical exam, positive stool culture for pathogens; febrile infants; Hirschsprung's disease,; coagulopathy, systemic disease, consumption of formula
Age
To 12 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Moallem square, Sari, Iran
City
Sari
Postal code
Approval date
2017-06-13, 1396/03/23
Ethics committee reference number
IR.MAZUMS.REC.96.2123

Health conditions studied

1

Description of health condition studied
Adverse effects, not elsewhere classified
ICD-10 code
T78
ICD-10 code description
Allergy, unspecified

Primary outcomes

1

Description
Calprotectin
Timepoint
0, 2, 4, 8, 12, 16 weeks
Method of measurement
ELIZA

2

Description
Bacterial growth in culture
Timepoint
0, 4, 16 weeks
Method of measurement
Stool culture

3

Description
WBC, RBC and occult blood
Timepoint
0, 2, 4, 8, 12, 16 weeks
Method of measurement
Stool analysis

Secondary outcomes

1

Description
The number of stools per week
Timepoint
0, 2, 4, 8, 12, 16 weeks
Method of measurement
Interview with infant's Mother

2

Description
The number of mucoid per week
Timepoint
0, 2, 4, 8, 12, 16 weeks
Method of measurement
Interview with infant's Mother

3

Description
Number of blood in the stool per week
Timepoint
0, 2, 4, 8, 12, 16 weeks
Method of measurement
Interview with infant's Mother

4

Description
Pain duration in week (minute)
Timepoint
0, 2, 4, 8, 12, 16 weeks
Method of measurement
Interview with infant's Mother

Intervention groups

1

Description
The control group receives the same package containing Aptamil Pepti Junior formula one sachet per day for 4 weeks
Category
Placebo

2

Description
For the intervention group, in addition to diet protocol, one sachet Protexin probiotic made by Health care co. is administered daily for 4 weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Bouali Sina Hospital
Full name of responsible person
Street address
Bouali Sina Hospital, Pasdaran Boulevard, Sari
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmadali Enayati
Street address
Sari
City
Sari
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 of Mazandaran 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
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hassan Karami, MD
Position
Associate proffessor
Other areas of specialty/work
Street address
Boualisina hospital, Pasdaran boulevard, Sari
City
Sari
Postal code
Phone
+98 11 3334 2334
Fax
Email
hakarami@mazums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hassan Karami, MD
Position
Associate professor
Other areas of specialty/work
Street address
Boualisina hospital, Pasdaran boulevard, Sari
City
Sari
Postal code
Phone
+98 11 3334 2334
Fax
Email
hakarami@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sahar Borna
Position
Student
Other areas of specialty/work
Street address
Sari
City
Sari
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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