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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027102
Receipt No. R000031062
Scientific Title A before-after study of tolerance induction by very low-dose oral immunotherapy for peanut allergy
Date of disclosure of the study information 2017/05/02
Last modified on 2017/08/25

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Basic information
Public title A before-after study of tolerance induction by very low-dose oral immunotherapy for peanut allergy
Acronym efficacy of peanut VLOIT
Scientific Title A before-after study of tolerance induction by very low-dose oral immunotherapy for peanut allergy
Scientific Title:Acronym efficacy of peanut VLOIT
Region
Japan

Condition
Condition food allergy
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy of very low-dose Oral Immunotherapy for peanut allergy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference of successfull comsumed dose of peanut oral food challenge between baseline and month 12.
Key secondary outcomes Difference of peanut specific-IgE and IgG4, Ara h 2 specific-IgE and IgG4, and wheal size of peanut SPTs between baseline and month 12.
Difference of peanut specific-IgE at month 12 between the VLOIT group and the Control group, which consisted of peanut specific-IgE at baseline matched 20 patients who avoid peanut for 12 months.
Difference of absolute change in wheal size of peanut SPTs from baseline to month 12 between the VLOIT group and the Control group.
Difference of parcentage change in peanut specific-IgG4 and Ara h 2 specific-IgE and IgG4 from baseline to month 12 between the VLOIT group and the Control group.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Very low-dose oral immunotherapy with peanut.
Participants take 0.0092 mg of peanut protein daily as first dose. The doses are increased double times every 7 intakes up to 5.74 mg of peanut protein.
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

Not applicable
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Patients who have result of peanut SPT and blood test (total IgE, peanut s-IgE and Ara h 2 s-IgE) within 3 months and eliminate peanut.
Patients with positive open label oral food challenge (exclude oral around symptom) less than or equal to 1.4 g of peanuts, which contained 35.7 mg peanut protein.(only VLOIT group)
Key exclusion criteria Patients with uncontrollable asthma or atopic dermatitis.
Patients with chronic urticaria.
Patients who do immunotherapy of other foods within 2 hours before and after this treatment.
Patients whom the doctor assesses ineligible.
Target sample size 20

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, Higasi-ku, Hamamatsu, Sizuoka
TEL 053-435-2111
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 053-435-2111
Homepage URL
Email natsumeo@hama-med.ac.jp

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

Funding Source
Organization No Organization
Organization
Division
Category of Funding Organization Other
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 浜松医科大学医学部附属病院(静岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 02 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
2017 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Of the secondary outcome, blood test and SPT are compared with the control group. The control group registers 40 people who are avoiding peanut. Then 20 participants among them are selected based on peanut specific-IgE at baseline matched to the VLOIT group.

Management information
Registered date
2017 Year 04 Month 22 Day
Last modified on
2017 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031062

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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