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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020874
Receipt No. R000024088
Scientific Title The effect of bovine colostrum on Recurrent Respiratory Infection and Diarrhea in children
Date of disclosure of the study information 2016/02/10
Last modified on 2017/02/16

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Basic information
Public title The effect of bovine colostrum on Recurrent Respiratory Infection and Diarrhea in children
Acronym Bovine colostrum on Recurrent infections
Scientific Title The effect of bovine colostrum on Recurrent Respiratory Infection and Diarrhea in children
Scientific Title:Acronym Bovine colostrum on Recurrent infections
Region
Africa

Condition
Condition To evaluate the efficacy and tolerability of bovine colostrum in preventing recurrent episodes of upper respiratory
tract infections and diarrhea in children
Classification by specialty
Gastroenterology Pneumology Infectious disease
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and tolerability of bovine colostrum in preventing recurrent episodes of upper respiratory
tract infections and diarrhea in children
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Episodes of URTI and diarrhoea reduced significantly at the end of therapy respectively.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Children (1-6 yrs) having recurrent episodes of upper respiratory tract infections or diarrhea received Bovine
Colostrum for 4 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
1 years-old <=
Age-upper limit
6 years-old >=
Gender Male and Female
Key inclusion criteria Children having
recurrent episodes of upper respiratory tract infections or having recurrent episodes of diarrhea
during the period 6 months prior to
enrollment in the study were included in the study.
Key exclusion criteria Children, having any abnormalities of the respiratory tract, or those children receiving corticosteroids
(systemic or topical), immunomodulators or when parent/guardian did not give informed consent, were excluded.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Khaled Saad
Organization faculty of medicine, Assiut university
Division name faculty of medicine
Zip code
Address Faculty of Medicine, Assiut University, Assiut, Egypt
TEL +20882413683
Email med@aun.edu.eg

Public contact
Name of contact person
1st name
Middle name
Last name Khaled Saad
Organization Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Division name pediatrics
Zip code
Address Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL +81-020882368373
Homepage URL
Email med@aun.edu.eg

Sponsor
Institute Faculty of medicine, University of Assiut, Assiut 71516, Egypt
Institute
Department

Funding Source
Organization Faculty of medicine, University of Assiut, Assiut 71516, Egypt
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 04 Day
Last modified on
2017 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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