UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029251
Receipt number R000032912
Scientific Title The effect of oral immunotherapy for food allergy
Date of disclosure of the study information 2017/11/01
Last modified on 2022/09/26 17:24:19

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Basic information

Public title

The effect of oral immunotherapy for food allergy

Acronym

The effect of oral immunotherapy for food allergy

Scientific Title

The effect of oral immunotherapy for food allergy

Scientific Title:Acronym

The effect of oral immunotherapy for food allergy

Region

Japan


Condition

Condition

food allergy

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of oral immunotherapy for food allergy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Percentage of patients who achieved target dose after 1, 2 and 3 years of treatment

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

gradually increased ingestion of responsible food

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

3 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with history of immediate reaction after ingestion of relevant food (egg, milk or wheat) within 6 months

Key exclusion criteria

Patients with poorly controlled asthma or atopic dermatitis

Target sample size

50


Research contact person

Name of lead principal investigator

1st name yuko
Middle name
Last name hamahata

Organization

Saitama city hospital

Division name

Department of pediatrics

Zip code

336-8522

Address

2460 Mimuro Midoriku Saitama-city, Saitama

TEL

+81-48-873-4111

Email

y.hamahata1210@gmail.com


Public contact

Name of contact person

1st name yuko
Middle name
Last name hamahata

Organization

Saitama city hospital

Division name

Department of pediatrics

Zip code

3368522

Address

2460 Mimuro Midoriku Saitama-city, Saitama

TEL

+81-48-873-4111

Homepage URL


Email

y.hamahata1210@gmail.com


Sponsor or person

Institute

Saitama city hospital

Institute

Department

Personal name



Funding Source

Organization

no funding source

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

Saitama city hospital

Address

2460 Mimuro Midoriku Saitama-city, Saitama

Tel

0488734111

Email

hsp-jimukyoku-somu@city.saitama.lg.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

2017 Year 11 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


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

Enrolling by invitation

Date of protocol fixation

2017 Year 09 Month 22 Day

Date of IRB

2017 Year 09 Month 13 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2025 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 22 Day

Last modified on

2022 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032912


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name