UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049974 |
|---|---|
| Receipt number | R000056922 |
| Scientific Title | A Parallel Group Randomized Double-Blind Trial in Healthy Subjects Study on the Effect of 8 Weeks of Continuous Intake of Food Containing LPS on Allergic Reactions in the Nasal Eye |
| Date of disclosure of the study information | 2023/01/06 |
| Last modified on | 2024/04/19 09:20:41 |
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Basic information
Public title
A study of the effect of LPS-containing foods on nasal eye allergic reactions.
Acronym
A study of the effect of LPS-containing foods on nasal eye allergic reactions.
Scientific Title
A Parallel Group Randomized Double-Blind Trial in Healthy Subjects Study on the Effect of 8 Weeks of Continuous Intake of Food Containing LPS on Allergic Reactions in the Nasal Eye
Scientific Title:Acronym
A Double-Blind Study on the Effects of 8-Week Consumption of Food Products Containing LPS on Nasal Eye Allergic Reactions
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of LPS-containing foods on nasal eye allergic reactions in healthy subjects in the normal range after 8 weeks of continuous consumption.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japan Allergic Rhinitis Standard Quality of Life Questionnaire (JRQLQ)
Key secondary outcomes
1)Nonspecific IgE, Specific IgE (house dust, cedar pollen)
2) Eosinophil count
3)Hematology examination
4)Biochemical examination
5)Height, Weight, BMI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the test food for 8 weeks
Interventions/Control_2
Intake of the placebo food for 8 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Persons in the healthy range between 20 and 65 years of age who have experienced nasal eye allergic reactions.
2) Patients with nasal and eye symptoms according to the "Japanese Allergic Rhinitis Standard Quality of Life Questionnaire" or with specific IgE (both house dust and cedar pollen) of 0.35 UA/mL or higher.
3) The applicant must have received an explanation of the study prior to participating in the study, understand the details of the study, and agree to participate in the study.
Key exclusion criteria
1) Currently taking medication or visiting a hospital for the treatment of any disease.
2) Currently under the supervision of a physician for exercise or diet therapy.
3) Persons who are at risk of developing allergies to the test food.
4) Pregnant women and nursing mothers.
5) Smokers.
6) Use of any medication during the 4 weeks prior to the start of the study that the study physician determines will affect participation in the study.
7) Inability to stop eating foods during the study period that the study physician determines may affect participation in the study.
8) Those who are participating or will participate in other clinical trials.
9) Persons who have donated at least 400 mL of blood at least 3 months prior to the date of consent or at least 200 mL of blood at least 1 month prior to the date of consent.
10) Any other person who has been judged by the investigator to be ineligible to participate in the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshimura |
Organization
Innate Immune Network
Division name
Clinical subcommittee
Zip code
761-0301
Address
Kagawa prefecture 2217-16 Takamatsu Shi Hayashi cho FROM Kagawa 3rd floor biotechnology laboratory
TEL
087-813-9201
npolsinlsin@lsin.org
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Nakamoto |
Organization
Innate Immune Network
Division name
Secretariat
Zip code
761-0301
Address
Kagawa prefecture 2217-16 Takamatsu Shi Hayashi cho FROM Kagawa 3rd floor biotechnology laboratory
TEL
087-813-9201
Homepage URL
npolsinlsin@lsin.org
Sponsor or person
Institute
Innate Immune Network
Institute
Department
Personal name
Funding Source
Organization
Macrophi Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee,Innate Immune Network
Address
Kagawa prefecture 2217-16 Takamatsu Shi Hayashi cho FROM Kagawa 3rd floor biotechnology laboratory
Tel
087-813-9201
npolsinlsin@lsin.org
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
| 2023 | Year | 01 | Month | 06 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 01 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056922
