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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034808
Receipt No. R000039697
Official scientific title of the study 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

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Basic information
Official scientific title of the study A prospective study of tolerance induction by continued very low-dose oral immunotherapy (VLOIT) for peanut allergy
Title of the study (Brief title) 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 Natsume Osamu
Organization Hamamatsu University School of Medicine
Division name department of pediatrics
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 Natsume Osamu
Organization Hamamatsu University School of Medicine
Division name department of pediatrics
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 0534352111
Homepage URL
Email natsumeo@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine, department of pediatrics
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.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


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