UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020874 |
|---|---|
| Receipt number | 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 14:21:33 |
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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
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
med@aun.edu.eg
Sponsor or person
Institute
Faculty of medicine, University of Assiut, Assiut 71516, Egypt
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024088
