UMIN-CTR Clinical Trial

Basic information
Public title	Studies on the inhibitory effect of DHA / EPA supplementation on immediate-type food allergic reactions
Acronym	Studies on the inhibitory effect of DHA / EPA supplementation on immediate-type food allergic reactions
Scientific Title	Studies on the inhibitory effect of DHA / EPA supplementation on immediate-type food allergic reactions
Scientific Title:Acronym	Studies on the inhibitory effect of DHA / EPA supplementation on immediate-type food allergic reactions
Region	Japan

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

Objectives
Narrative objectives1	To verify the effects of supplementing DHA / EPA on plasma fatty acid to reduce immediate food allergic reaction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in ratio of Total score of Anaphylaxis scoring aichi (ASCA) divided by cumulative load protein.
Key secondary outcomes	1. Change in plasma total lipid fatty acid fraction: Change in (EPA + DHA) / AA ratio 2. Change in total IgE value 3. Changes in specific IgE levels 4. Changes in intestinal flora analysis

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	Continue to take dairy lactic acid bacteria beverage containing 720 mg DHA and 180 mg EPA once a day for 5 days or more a week. Taking the test food for 12-15 weeks.
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	3 years-old <=
Age-upper limit	10 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients who tested positive for OFC in eggs (Boiled egg whites) and were instructed to completely remove them. 2. Patients aged between 3 and younger than 10 3. Patients who tasted a test food and are expected to consume it continuously for three months 4. Patients who can receive the test food once a week 5. Patients who are not allergic to milk
Key exclusion criteria	1. Patients who are taking supplements such as DHA containing food or probiotic food continuously. 2. Patients with TS score of 41 or higher induced by initial OFC (Patients for whom the safety of the evaluation OFC is not guaranteed) 3. Patients who have systemic diseases other than allergies 4. Patients who are judged by a physician to be unsuitable
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Komei Middle name Last name Ito
Organization	Aichi Children's Health and Medical Center
Division name	Department of General Pediatrics and allergy
Zip code	474-8710
Address	7-426, Morioka-cho, Obu-shi, Aichi, Japan.
TEL	0562-43-0500
Email	koumei_itoh@mx.achmc.pref.aichi.jp

Public contact
Name of contact person	1st name Yukiko Middle name Last name Iwawaki
Organization	Aichi Children's Health and Medical Center
Division name	Department of Allergy
Zip code	474-8710
Address	7-426, Morioka-cho, Obu-shi, Aichi, Japan.
TEL	0562-43-0500
Homepage URL
Email	allergy-secretary@cd5.so-net.ne.jp

Sponsor
Institute	Aichi Children's Health and Medical Center
Institute
Department

Funding Source
Organization	ORTHOMEDICO Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nobel CO,.LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Takara Clinic Certified Review Board
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	CRB@takara-clinic.com

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs031190192
Org. issuing International ID_1	Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	あいち小児保健医療総合センター (愛知県) Aichi Children's Health and Medical Center (Aichi, Japan)

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 30 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 12 Month 03 Day
Date of IRB	2019 Year 12 Month 03 Day
Anticipated trial start date	2020 Year 02 Month 28 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 30 Day
Last modified on	2020 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044842