UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039324
Receipt No. R000044842
Scientific Title Studies on the inhibitory effect of DHA / EPA supplementation on immediate-type food allergic reactions
Date of disclosure of the study information 2020/01/30
Last modified on 2020/04/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.