UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000033254
Receipt number R000037913
Scientific Title clinical trials for food allergic children with oral immunotherapy with a very small amount of allergen
Date of disclosure of the study information 2018/07/07
Last modified on 2023/07/08 18:05:14

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Basic information

Public title

clinical trials for food allergic children with oral immunotherapy with a very small amount of allergen

Acronym

oral immunotherapy with a very small amount of allergen

Scientific Title

clinical trials for food allergic children with oral immunotherapy with a very small amount of allergen

Scientific Title:Acronym

oral immunotherapy with a very small amount of allergen

Region

Japan


Condition

Condition

food allergy

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It aims to establish oral immunotherapy which is safe and highly effective against food allergy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Number of cases that could cause release of the causative food to the remission level within 3 years from the start of oral immunotherapy

Key secondary outcomes

Compliance rate of protocol.
Blood test analysis in progress.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Egg:start dose = <0.2g
Milk:start dose = <0.2g
wheat:start dose = <0.2g
Others(e.g. peanuts, fish,)=<0.2g
Start ingestion and gradually increase. Continue for 3 years.

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

15 years-old >=

Gender

Male and Female

Key inclusion criteria

Children who have been diagnosed with food allergies and who are judged to be oral immunotherapy for allergy specialized outpatient clinics.
Specific serum IgE positive and obvious history of food allergy/oral food challenge test positive.

Key exclusion criteria

1.Patient with congenital disease such as chromosomal abnormalities.
2.Child with severe complication history (congenital heart disease, childhood blood tumor disease, surgical operation history).
3.Patient with bronchial asthma that applies to the control status "bad".
4.Contraindication example of administration of adrenaline intramuscular injection preparation
5.Other who judged that the research director is inappropriate as the research subject.



Target sample size

60


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

Department of Pediatrics and Adolescent Medicine

Zip code

113-8421

Address

Bunkyo-ku,3-1-3

TEL

0338133111

Email

tshimizu@juntendo.ac.jp


Public contact

Name of contact person

1st name Susumu
Middle name
Last name Yamazaki

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Pediatrics and Adolescent Medicine

Zip code

113-8421

Address

Bunkyo-ku, 3-1-3

TEL

0338133111

Homepage URL


Email

susumu@juntendo.ac.jp


Sponsor or person

Institute

Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JPN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Juntendo University Graduate School of Medicine

Address

Bunkyo-ku, 3-1-3

Tel

0338133111

Email

kenkyu5858@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

順天堂大学附属順天堂医院


Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 07 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

Terminated

Date of protocol fixation

2018 Year 07 Month 01 Day

Date of IRB

2018 Year 07 Month 01 Day

Anticipated trial start date

2018 Year 07 Month 01 Day

Last follow-up date

2023 Year 03 Month 01 Day

Date of closure to data entry

2023 Year 03 Month 30 Day

Date trial data considered complete

2023 Year 03 Month 30 Day

Date analysis concluded

2023 Year 03 Month 30 Day


Other

Other related information

Since the intervation of "dietary guidance" and "oral immunotherapy" became ambiguous in the subjects included, we decided to stop the study and review it.


Management information

Registered date

2018 Year 07 Month 03 Day

Last modified on

2023 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037913


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name