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
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
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
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
