UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017416
Receipt number R000019847
Scientific Title Slow Low-dose Oral Immunotherapy [SLOIT] for children with food allergies - non-randomized control trial -
Date of disclosure of the study information 2015/05/04
Last modified on 2020/05/07 14:28:30

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Basic information

Public title

Slow Low-dose Oral Immunotherapy [SLOIT] for children with food allergies - non-randomized control trial -

Acronym

SLOIT for food allergies

Scientific Title

Slow Low-dose Oral Immunotherapy [SLOIT] for children with food allergies - non-randomized control trial -

Scientific Title:Acronym

SLOIT for food allergies

Region

Japan


Condition

Condition

food allergy

Classification by specialty

Clinical immunology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of Slow Low-dose Oral Immunotherapy (SLOIT)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the proportion of patients with negative results of oral food challenge for boiled egg white, cow's milk, udon noodle (0.2 - 0.5 - 1 - 2 - 5g or mL 30min interval)

Key secondary outcomes

Safety and continuity of the therapy.
The threshold dose of antigen and severity of allergic reaction provoked in OFCs.
The shift of laboratory data (e.g. specific IgE titer)
The frequency of rescue drug use and emergency department visit due to expected and unexpected allergic reaction in both groups.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Slow Low-dose Oral Immunotherapy
Ingesting allergen(boiled egg white, whole milk, udon noodle) every day according to the protocol.

Interventions/Control_2

elimination diet

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

2 years-old <

Age-upper limit

18 years-old >=

Gender

Male and Female

Key inclusion criteria

patient with severe food allergy for egg, milk, wheat diagnosed by oral food challenge

Key exclusion criteria

patients during oral immunotherapy for other food antigen
patients with severe comorbidity
patients with uncontrollable asthma or atopic dermatitis
patients whose parents can not manage adrenalin autoinjector
patients who have developed anaphylaxis by tiny antigen (less than 1mL of milk or 1g of boiled egg, udon noodle) within one year before the oral food challenge.
patients whom the doctor asses ineligible

Target sample size

300


Research contact person

Name of lead principal investigator

1st name komei
Middle name
Last name Ito

Organization

Aichi Children's Health and Medical Center

Division name

Department of Allergy

Zip code

474-8710

Address

7-426, Morioka, Obu, Aichi 474-8710, Japan

TEL

0562-43-0500

Email

koumei_itoh@mx.achmc.pref.aichi.jp


Public contact

Name of contact person

1st name Shiro
Middle name
Last name Sugiura

Organization

Aichi Children's Health and Medical Center

Division name

Department of Allergy

Zip code

474-8710

Address

7-426, Morioka, Obu, Aichi 474-8710, Japan

TEL

0562-43-0500

Homepage URL


Email

bee_jayz@hotmail.com


Sponsor or person

Institute

Aichi Children's Health and Medical Center

Institute

Department

Personal name



Funding Source

Organization

Nothing

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

Aichi Childrens Health and Medical Center

Address

7-426, morioka, obu, Aichi

Tel

0562-43-0500

Email

bee_jayz@hotmail.com


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

2015 Year 05 Month 04 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

Completed

Date of protocol fixation

2015 Year 02 Month 25 Day

Date of IRB

2015 Year 03 Month 26 Day

Anticipated trial start date

2015 Year 03 Month 04 Day

Last follow-up date

2018 Year 06 Month 30 Day

Date of closure to data entry

2018 Year 07 Month 30 Day

Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 05 Month 04 Day

Last modified on

2020 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019847


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name