UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040531
Receipt number R000046267
Scientific Title Low-dose oral immunotherapy for food allergies (buckwheat, fruits, walnuts, cashews, hazelnuts, and macadamia nuts).
Date of disclosure of the study information 2020/05/26
Last modified on 2020/11/26 16:26:01

* 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

Low-dose oral immunotherapy for food allergies (buckwheat, fruits, walnuts, cashews, hazelnuts, and macadamia nuts).

Acronym

Low-dose oral immunotherapy

Scientific Title

Low-dose oral immunotherapy for food allergies (buckwheat, fruits, walnuts, cashews, hazelnuts, and macadamia nuts).

Scientific Title:Acronym

Low-dose oral immunotherapy

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 low-dose oral immunotherapy for food allergies.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The rate of short-term unresponsiveness* to the middle-dose** after 1 year

* Short-term unresponsiveness is defined as "when patients passed the middle-dose oral food challenge after complete avoidance for 2 weeks."
** The middle-dose is defined as "16 g buckwheat noodle, 40 g fruits, and 3 g walnuts, cashews, hazelnuts, and macadamia nuts."

Key secondary outcomes

1. Frequency of adverse reactions
2. The rate of short-term unresponsiveness* to the middle-dose** after 2 years, 3 years, 4 years, and 5 years from the start of oral immunotherapy(OIT)
3. Changes of specific IgE, IgG, and IgG4
* Short-term unresponsiveness is defined as "when patients passed the middle-dose oral food challenge after complete avoidance for 2 weeks."
** The middle-dose is defined as "16 g buckwheat noodle, 40 g fruits, and 3 g walnuts, cashews, hazelnuts, and macadamia nuts."


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

1.The target amount of ingestion is defined as 2 g buckwheat noodle, 10 g fruits, and 0.5 g walnuts, cashews, hazelnuts, and macadamia nuts.
2.The subjects are asked to take a small amount of their causative food at the inpatient department. The amount is gradually built up to their target amount depending on their symptoms.
3.The subjects continue to ingest their causative foods for a year after discharge from the hospital.

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

18 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who visited our hospital and exhibited objective symptoms based on the oral food challenge with one of the following food products are included in this study; 2 g buckwheat noodle (100 mg buckwheat protein), 5 g fruits, 0.5 g walnuts (75 mg walnut protein), 0.5 g cashews (90 mg cashew protein), 0.5 g hazelnuts (75 mg hazelnut protein), and 0.5 g macadamia nuts (45 mg macadamia nut protein).
Objective symptoms were based on the Japanese Society of Allergology anaphylaxis guidelines (Yanagida N. et al. Allergol Int 2016, Ebisawa M. et al. Allergol Int 2017.).

Key exclusion criteria

1.The subject who has poorly treated atopic dermatitis and bronchial asthma.
2.The subject who seems inappropriate candidate for oral immunotherapy as judged by a medical doctor.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Motohiro
Middle name
Last name Ebisawa

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of Allergy, Clinical Research Center for Allergy and Rheumatology

Zip code

252-0392

Address

18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.

TEL

042-742-8311

Email

mebisawa@foodallergy.jp


Public contact

Name of contact person

1st name Noriyuki
Middle name
Last name Yanagida

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Clinical Research Center for Allergy and Rheumatology

Zip code

252-0392

Address

18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.

TEL

042-742-8311

Homepage URL


Email

yana@foodallergy.jp


Sponsor or person

Institute

National Hospital Organization Sagamihara National Hospital

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

National Hospital Organization Sagamihara National Hospital

Address

18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.

Tel

042-742-8311

Email

222-rinri@mail.hosp.go.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

2020 Year 05 Month 26 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

Open public recruiting

Date of protocol fixation

2015 Year 10 Month 01 Day

Date of IRB

2015 Year 11 Month 17 Day

Anticipated trial start date

2015 Year 11 Month 17 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 05 Month 26 Day

Last modified on

2020 Year 11 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046267


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name