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

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 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


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

Value
https://center6.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