UMIN-CTR Clinical Trial

Public title

Stepwise peanut oral food challenge

Acronym

Stepwise peanut oral food challenge

Scientific Title

Efficacy of stepwise oral food challenge in children suspected of peanut allergy

Scientific Title:Acronym

Stepwise peanut oral food challenge

Region

Japan

Condition

food allergy

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of stepwise peanut oral food challenge

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The rate of positive oral food challenge

The rate of anaphylaxis induced by oral food challenge

Key secondary outcomes

Reproducibility of negative or uncertain oral food challenge results at home
The change in peanut, Ara h 2 specific IgE levels

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Food

Interventions/Control_1

Patients suspected of peanut allergy receive stepwise oral food challenge.
Patients with Ara h 2 specific IgE greater than 4.0 kUA/L start with a very low dose oral food challenge.
Patients with Ara h 2 specific IgE less than 4.0 kUA/L and have a past history of immediate type reaction start with low dose oral food challenge.
Patients with Ara h 2 specific IgE less than 4.0 kUA/L and have no history of immediate reaction start with middle dose oral food challenge.

Very low dose oral food challenge;
oral food challenge with 0.12g of peanut powder

Low dose oral food challenge; oral food challenge with 0.5g of peanut or peanut powder contained in foods such as pumpkin cake and hamburger steak

Middle dose oral food challenge; oral food challenge with 3g of peanut or peanut powder contained in foods such as pumpkin cake and hamburger steak

Full dose oral food challenge; oral food challenge with 10g of peanut or peanut powder contained in foods such as pumpkin cake and hamburger steak

The patients who pass each oral food challenge receive next oral food challenge if the results are negative.

All oral food challenges are performed in a single dose or in two doses.
In the two-dose oral food challenges, challenged foods are administered in a 60 min interval.

The patients classified as negative or uncertain in very low dose oral food challenge are then given 0.12g of peanut powder and instructed to consume it >2 times at home.

The patients classified as negative or uncertain in low dose or middle dose or full dose oral food challenge are instructed to consume the same amount >2 times at home.

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who receive peanut oral food challenges at our hospital

Key exclusion criteria

The subjects who are undergoing oral immunotherapy or epicutaneous immunotherapy
The subjects who disagree to participate in the study
The subjects judged inappropriate for the study by the research director

Target sample size

172

Name of lead principal investigator

1st name	Noriyuki
Middle name
Last name	Yanagida

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of Pediatrics

Zip code

252-0392

Address

18-1, Sakuradai, Minamiku, Sagamiharashi, Kanagawa, Japan

TEL

042-742-8311

Email

yana@foodallergy.jp

Name of contact person

1st name	Ken-ichi
Middle name
Last name	Nagakura

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of Pediatrics

Zip code

252-0392

Address

18-1, Sakuradai, Minamiku, Sagamiharashi, Kanagawa, Japan

TEL

042-742-8311

Homepage URL

Email

k.nagakura@foodallergy.jp

Institute

National Hospital Organization Sagamihara National Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Hospital Organization Sagamihara National Hospital

Address

18-1, Sakuradai, Minami-ku, Sagamihara, Kanagawa 252-0392, Japan

Tel

042-742-8311

Email

222-rinri@mail.hosp.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

12

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2020

Year

10

Month

08

Day

Date of IRB

2020

Year

11

Month

18

Day

Anticipated trial start date

2020

Year

12

Month

25

Day

Last follow-up date

2040

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

12

Month

25

Day

Last modified on

2020

Year

12

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048918