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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008263
Receipt No. R000009739
Scientific Title Expression of inflammatory signaling molecules in food protein-induced enterocolitis syndrome and rectal bleeding in infancy.
Date of disclosure of the study information 2012/07/01
Last modified on 2014/06/27

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Basic information
Public title Expression of inflammatory signaling molecules in food protein-induced enterocolitis syndrome and rectal bleeding in infancy.
Acronym Analysis of signaling molecules in rectal bleeding in infancy.
Scientific Title Expression of inflammatory signaling molecules in food protein-induced enterocolitis syndrome and rectal bleeding in infancy.
Scientific Title:Acronym Analysis of signaling molecules in rectal bleeding in infancy.
Region
Japan

Condition
Condition Infants with rectal bleeding
Classification by specialty
Gastroenterology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the pathogenesis of rectal bleeding in infancy.
Basic objectives2 Others
Basic objectives -Others To examine the mechanisms of rectal bleeding in infancy.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To examined the expression of signaling molecules in rectal bleeding in infancy.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
0 months-old <=
Age-upper limit
12 months-old >
Gender Male and Female
Key inclusion criteria Infants with rectal bleeding.
Key exclusion criteria Infants needing for surgical treatment.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Ohtsuka
Organization Juntendo University Graduate School of Medicine
Division name Department of Pediatrics and Adolescent Medicine
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-3813-3111
Email yohtsuka@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshikazu Ohtsuka
Organization Juntendo University Graduate School of Medicine
Division name Department of Pediatrics and Adolescent Medicine
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-3813-3111
Homepage URL
Email yohtsuka@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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 順天堂大学医学部附属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2012 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2012 Year 07 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 Inflammatory signaling molecules with rectal bleeding in infancy.

Management information
Registered date
2012 Year 06 Month 26 Day
Last modified on
2014 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009739

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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