UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030843
Receipt number R000035213
Scientific Title A study of fecal protein loosing in pediatric Kawasaki's disease patients.
Date of disclosure of the study information 2018/04/01
Last modified on 2024/01/21 12:20:03

* 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

A study of fecal protein loosing in pediatric Kawasaki's disease patients.

Acronym

A study of fecal protein loosing in pediatric Kawasaki's disease patients.

Scientific Title

A study of fecal protein loosing in pediatric Kawasaki's disease patients.

Scientific Title:Acronym

A study of fecal protein loosing in pediatric Kawasaki's disease patients.

Region

Japan


Condition

Condition

Kawasaki's disease

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Kawasaki Disease is a systemic vasculitic disease. We often experiences hypoproteinemia in the acute phase of Kawasaki disease. However, there is no report that investigates the involvement of protein leakage due to intestinal mucosal lesion. The purpose of this study is to measure and analyze fecal alpha1-antitrypsin over time in order to examine protein leakage into feces in pediatric Kawasaki's disease patients.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in fecal alpha1-antitrypsin levels between the acute and remission phase of Kawasaki's disease

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Enema twice for acupuncture (acute phase and remission phase), 1 dose is 2 ml / kg

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

1. Children of 0 to 6-year old at consent income.
2. Consent in writing has been obtained from the substitute for participation in the research.
3. Children which meets the diagnostic criteria of Kawasaki's disease.

Key exclusion criteria

1. Children having chronic gastrointestinal diseases (inflammatory bowel disease, protein loosing enteropathy, etc.) from the prevalence of Kawasaki's disease.
2. Children having an operation history such as intestinal resection.

Target sample size

160


Research contact person

Name of lead principal investigator

1st name Keisuke
Middle name
Last name Jimbo

Organization

Juntendo University, Faculty of Medicine

Division name

Department of Pediatrics

Zip code

1138421

Address

2-1-1, Hongo, Bunko-ku, Tokyo, 113-8421, Japan

TEL

03-3813-3111

Email

kjinbo@juntendo.ac.jp


Public contact

Name of contact person

1st name Keisuke
Middle name
Last name Jimbo

Organization

Juntendo University, Faculty of Medicine

Division name

Department of Pediatrics

Zip code

1138421

Address

2-1-1, Hongo, Bunko-ku, Tokyo, 113-8421, Japan

TEL

03-3813-3111

Homepage URL


Email

kjinbo@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University, Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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, Bunko-ku, Tokyo, 113-8421, Japan

Tel

0358021584

Email

kjinbo@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練馬病院小児科(東京都)、東部地域病院小児科(東京都)、豊島病院小児科(東京都)、多摩南部地域病院小児科(東京都)、賛育会病院小児科(東京都)、江東病院小児科(東京都)、東京臨海病院小児科(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 04 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

101

Results

The analysis has been completed and the paper is being written.
Detailed results will be published in the paper.

Results date posted

2024 Year 01 Month 21 Day

Results Delayed

Delay expected

Results Delay Reason

Not available

Date of the first journal publication of results


Baseline Characteristics

The analysis has been completed and the paper is being written.
Detailed results will be published in the paper.

Participant flow

The analysis has been completed and the paper is being written.
Detailed results will be published in the paper.

Adverse events

None

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2017 Year 11 Month 27 Day

Date of IRB

2017 Year 12 Month 26 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 16 Day

Last modified on

2024 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035213


Research Plan
Registered date File name
2023/01/20 ★研究計画書 変更後 事務局確認20191030.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name