UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A before-after study of tolerance induction by very low-dose oral immunotherapy for peanut allergy
Title of the study (Brief title)	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	Natsume Osamu
Organization	Hamamatsu University School of Medicine
Division name	department of pediatrics
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	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	053-435-2111
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000031062