UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009076
Receipt number R000010653
Scientific Title Comparison of low dose-maintenance trial with dose-escalation trial in oral immunotherapy for food allergy
Date of disclosure of the study information 2012/10/10
Last modified on 2022/04/18 09:42:08

* 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

Comparison of low dose-maintenance trial with dose-escalation trial in oral immunotherapy for food allergy

Acronym

Comparison of low dose-maintenance trial with dose-escalation trial in oral immunotherapy for food allergy

Scientific Title

Comparison of low dose-maintenance trial with dose-escalation trial in oral immunotherapy for food allergy

Scientific Title:Acronym

Comparison of low dose-maintenance trial with dose-escalation trial in oral immunotherapy for food allergy

Region

Japan


Condition

Condition

food allergy

Classification by specialty

Pediatrics Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of safety and efficacy in low dose-maintenance trial with those in dose-escalation trial in oral immunotherapy for food allergy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference of threshold of tolerance dose after treatment between low dose-maintainance trial and dose-escalation trial in oral immunothearpy for food allergy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

gradually increased ingestion of responsible food

Interventions/Control_2

low dose ingestion of responsible food

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

Patients with immediate allergic reaction for food challenge test

Key exclusion criteria

Patients with poorly controlled asthma or atopic dermatitis

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Masayuki
Middle name
Last name Akashi

Organization

Saitama municipal hospital

Division name

Pediatrics

Zip code

3368522

Address

2460 mimuro midoriku saitama city

TEL

+81-48-873-4111

Email

yuki0820@trust.ocn.ne.jp


Public contact

Name of contact person

1st name Masayuki
Middle name
Last name Akashi

Organization

Saitama municipal hospital

Division name

Pediatrics

Zip code

3368522

Address

2460 mimuro midoriku saitama city

TEL

0488734111

Homepage URL


Email

yuki0820@trust.ocn.ne.jp


Sponsor or person

Institute

Saitama municipal hospital

Institute

Department

Personal name



Funding Source

Organization

Kawano Masanori Memorial Foundation for Promotion of Pediatics

Organization

Division

Category of Funding Organization

Non profit foundation

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 Midori-ku Saitama

Tel

+81488734111

Email

yuki0820@trust.ocn.ne.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

さいたま市立病院 Saitama municipal hospital


Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 10 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

14

Results

Compared to the slow titration group, the threshold maintenance group experienced significantly fewer allergic symptoms and anaphylaxis during treatment. Two of the eight patients in the threshold maintenance treatment group who continued treatment t were able to consume an egg without obvious allergic symptoms, and three of the remaining six patients were able to consume more egg antigen than the maintenance dose in the loading test 12 months later.

Results date posted

2022 Year 04 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with hen's egg allergy between 3 and15 years of age

Participant flow

The children were treated for one year after their caregivers were asked to choose between threshold maintenance therapy, in which the intake was increased daily from a small amount and continued at the immediately preceding intake when allergic symptoms were observed, and slow titration therapy, a conventional oral immunotherapy.

Adverse events

any allergic reaction

Outcome measures

tolerance dose of hen's egg
serological change

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 08 Month 01 Day

Date of IRB

2012 Year 06 Month 13 Day

Anticipated trial start date

2012 Year 08 Month 01 Day

Last follow-up date

2013 Year 12 Month 29 Day

Date of closure to data entry

2020 Year 12 Month 29 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2021 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2012 Year 10 Month 10 Day

Last modified on

2022 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010653


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name