UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034808
Receipt number R000039697
Scientific Title A prospective study of tolerance induction by continued very low-dose oral immunotherapy (VLOIT) for peanut allergy
Date of disclosure of the study information 2018/11/07
Last modified on 2018/11/07 22:31:10

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Basic information

Public title

A prospective study of tolerance induction by continued very low-dose oral immunotherapy (VLOIT) for peanut allergy

Acronym

VLOIT on study

Scientific Title

A prospective study of tolerance induction by continued very low-dose oral immunotherapy (VLOIT) for peanut allergy

Scientific Title:Acronym

VLOIT on study

Region

Japan


Condition

Condition

Food Allergy

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and the efficacy of continued Very Low Oral Immunotherapy (VLOIT) for peanut allergy after continuation of VLOIT for 1 year.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

The difference of negative rate of OFC with 14 g of peanuts between the VLOIT group and the removal group after 36 months.

Key secondary outcomes

The difference of absolute change in successful consumed dose from baseline to months 24 and 36 between the VLOIT group and the removal group.

The difference of peanut specific-IgE and IgG4, Ara h2 specific-IgE and IgG4, and wheal size of peanut SPTs between baseline and month 24 or 36.

The difference of absolute change in wheal size of peanut SPTs from baseline to months 24 and 36 between the VLOIT group and the removal group.
The difference of percentage change in peanut-specific IgE and IgG4, Ara h 2-specific IgE and IgG4 from baseline to months 24 and 36 between the VLOIT group and the removal group.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Participants take 5.7-143 mg of peanut protein daily for two years.

Interventions/Control_2

Participants continue removing peanut.

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

16 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Participants of VLOIT study (UMIN000027102)
2.Patients under 16 years old.
3.Patients who agreed to participate in this study in writing.

Key exclusion criteria

1.Patients whom atopic dermatitis or bronchial asthma are uncontrolled.
2.Patients with chronic urticaria.
3.Patients whom undergo another oral immunotherapy within 2 hours.
4.Patients who the doctor assesses ineligible.
5.Patient who were administered anti-histamine or LTRA for peanut allergy.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Natsume Osamu

Organization

Hamamatsu University School of Medicine

Division name

department of pediatrics

Zip code


Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan

TEL

053-4352111

Email

natsumeo@hama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Natsume Osamu

Organization

Hamamatsu University School of Medicine

Division name

department of pediatrics

Zip code


Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan

TEL

0534352111

Homepage URL


Email

natsumeo@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine, department of pediatrics

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 11 Month 07 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

Preinitiation

Date of protocol fixation

2018 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 11 Month 07 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 11 Month 07 Day

Last modified on

2018 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039697


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name