UMIN-CTR Clinical Trial

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