UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027102 |
|---|---|
| Receipt number | 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 06:20:23 |
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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
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
natsumeo@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine, department of pediatrics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031062
