UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000011874
Receipt No. 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 (Ver. 7)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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)
Email 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
Email kjinbo@juntendo.ac.jp

Sponsor
Institute Hitachi, Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013878