UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of the efficacy of oral immunotherapy combined with Lactobacillus rhamnosus GG for patients with food allergy
Acronym	Analysis of the efficacy of oral immunotherapy combined with Lactobacillus rhamnosus GG
Scientific Title	Analysis of the efficacy of oral immunotherapy combined with Lactobacillus rhamnosus GG for patients with food allergy
Scientific Title:Acronym	Analysis of the efficacy of oral immunotherapy combined with Lactobacillus rhamnosus GG for patients with food allergy
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy of oral immunotherapy combined with Lactobacillus rhamnosus GG for children with severe food allergy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sustained unresponsiveness to middle dose after 12 months. Middle dose was defined as half of the whole egg, 25ml of cow's milk, 25g of udon noodle (Japanese wheat noodle), 3g of peanuts, or 3g of nuts.
Key secondary outcomes	Intestinal microbiota Short-chain fatty acids (acetic acid, butyric acid, propionic acid, valeric acid) in the serum Changes in specific IgE, IgG, and IgG4 titer Frequency of adverse reactions during therapy

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Patients consume Lactobacillus rhamnosus GG during the oral immunotherapy for 1 year.
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	5 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who reacted to low-dose oral food challenge. Low-dose was defined as 'one eighth of the whole egg, 3 ml of cow's milk, 2 g of udon noodle (Japanese wheat noodle), 0.5 g of whole peanuts, or 0.5 g of nuts.'
Key exclusion criteria	Decision of ineligibility by a physician
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Motohiro Middle name Last name Ebisawa
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code	252-0392
Address	18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL	042-742-8311
Email	yana@foodallergy.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name Miura
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Pediatrics
Zip code	252-0392
Address	18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL	042-742-8311
Homepage URL
Email	yoko6299@gmail.com

Sponsor
Institute	National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization	no
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Technical Research Laboratory Takanashi Milk Products Co. Ltd. Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization Sagamihara National Hospital
Address	18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel	042-742-8311
Email	furuta.harumi.we@mail.hosp.go.jp

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	2019 Year 07 Month 25 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	Enrolling by invitation
Date of protocol fixation	2019 Year 07 Month 11 Day
Date of IRB	2019 Year 06 Month 20 Day
Anticipated trial start date	2019 Year 07 Month 16 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 25 Day
Last modified on	2019 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042731

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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