UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011874 |
|---|---|
| Receipt number | R000013878 |
| Scientific Title | Studies and technological development of intestinal blood flow quantification by abdominal ultrasound in children. |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2019/07/29 23:40:47 |
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Basic information
Public title
Studies and technological development of intestinal blood flow quantification by abdominal ultrasound in children.
Acronym
Studies and technological development of intestinal blood flow quantification by abdominal ultrasound in children.
Scientific Title
Studies and technological development of intestinal blood flow quantification by abdominal ultrasound in children.
Scientific Title:Acronym
Studies and technological development of intestinal blood flow quantification by abdominal ultrasound in children.
Region
| Japan |
Condition
Condition
Pediatric gastrointestinal disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We develop ultrasonic intestinal blood flow quantification technique to perform the numerical evaluation of intestinal blood flow for each specific gastrointestinal disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal blood flow volume of gastrointestinal disease and normal control.
(1. Gastric antrum, 2. Duodenum, 3. Jejunum, 4. Terminal ileum, 5. Ileocecal, 6.Sigmoid colon)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Normal control group (non-gastrointestinal disease group)
Interventions/Control_2
Gastrointestinal disease group
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
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Food protein induced enterocolitis syndrome (FPIES) infants from 0-day-old to 1 month of age.
2. Pediatric gastrointestinal disease including infectious enterocolitis and inflammatory bowel disease from 0-day-old to 16-year-old.
3. The normal control is the children who have no abnormal findings in abdominal clinical examination and ultrasound.
Key exclusion criteria
Children with intensive body motion who do not allow us to take clear ultrasound image.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Shimizu |
Organization
Juntendo University Graduate School of Medicine
Division name
Pediatrics and Adolescent Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-383-3111(3326)
tshimizu@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Jimbo |
Organization
Juntendo University Graduate School of Medicine
Division name
Pediatrics and Adolescent Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111(3325)
Homepage URL
kjinbo@juntendo.ac.jp
Sponsor or person
Institute
Hitachi, Ltd.
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
chiken@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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000013878
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000013878
Number of participants that the trial has enrolled
110
Results
Analysis of the vessel density of the target disease was completed, and it was found that milk allergy was significantly elevated.
Results date posted
| 2019 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Gastrointestinal disease including milk allergy
Participant flow
Patient child who visited our hospital or hospitalized
Adverse events
none
Outcome measures
vessel density
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 26 | Day |
Last modified on
| 2019 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013878
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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