UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039324 |
|---|---|
| Receipt number | 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 13:04:58 |
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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
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
allergy-secretary@cd5.so-net.ne.jp
Sponsor or person
Institute
Aichi Children's Health and Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044842
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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