UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008263 |
|---|---|
| Receipt number | 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 | 2026/07/07 21:33:35 |
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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
| Not applicable |
Age-upper limit
| 6 | years-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 | Yoshikazu |
| Middle name | |
| Last name | Ohtsuka |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
yohtsuka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Ohtsuka |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
Homepage URL
yohtsuka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
2-1-1, Hongo, Bynkyo-ku, Tokyo, JAPAN
Tel
0338133111
yohtsuka@juntendo.ac.jp
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
Published in journals
Publication of results
Published
Result
URL related to results and publications
Published in journals
Number of participants that the trial has enrolled
22
Results
To investigate the pathogenesis of food protein-induced proctocolitis (FPIP) and neonatal transient eosinophilic colitis (NTEC), we examined the mucosal expression of inflammatory signals. Enhanced expression of IL-6, CCL11, and XCL13 was confirmed in both NTEC and FPIP. Mucosal infiltration of CD3- and IgA- positive cells were confirmed in both. Enhanced expression of CXCL13 was confirmed among these diseases suggested that IgA synthesis is an important task for the mucosal immune systems during infancy.
Results date posted
| 2026 | Year | 07 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
22 infants with bloody motion were enrolled in this study.
Participant flow
We examined the mucosal expression of inflammatory signals using microarray, RT-PCR, and immunohistochemical analysis.
Adverse events
None
Outcome measures
Published following papers.
1. Mori M, Ohtsuka Y, Ishida A, Yamazaki S, Jimbo K, Inage E, Aoyagi Y, Kudo T, Suzuki R, Shimizu T. Outcome of infants presenting rectal bleeding: A retrospective study in a single institution. Pediatr Int. 2014;56:884-890. doi: 10.1111/ped.12366
2. Jimbo K, Ohtsuka Y, Kojima Y, Hosoi K, Ohbayashi N, Ikuse T, Aoyagi Y, Fujii T, Kudo T, Shimizu T. Increased expression of CXCR3 axis components and matrix metalloproteinase in pediatric inflammatory bowel disease patients. Pediatr Int. 2014;56:873-883. doi: 10.1111/ped.12362
3. Ohtsuka Y, Jimbo K, Inage E, Mori M, Yamakawa Y, Aoyagi Y, Suzuki M, Kudo T, Suzuki R, Shimizu T. Microarray analysis of mucosal biopsy specimens in neonates with rectal bleeding: Is it really an allergic disease? J Allergy Clin Immunol 129:1676-8, 2012 doi: 10.1016/j.jaci.2012.01.042
4. Ikuse T, Ohtsuka Y, Kudo T, Hosoi K, Obayashi N, Jimbo K, Aoyagi Y, Fujii T, Nagata S, Shimizu T. Microarray analysis of gastric mucosa among children with Helicobacter pylori infections. Pediatr Int 54:319-24, 2012 doi: 10.1111/j.1442-200X.2012.03573.x
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
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
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009739
