UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046503 |
|---|---|
| Receipt number | R000053059 |
| Scientific Title | Efficacy Evaluation of a Food Containing Lactic Acid Bacteria to ocular and nasal symptoms of allergy |
| Date of disclosure of the study information | 2023/01/08 |
| Last modified on | 2021/12/28 14:59:53 |
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Basic information
Public title
Efficacy Evaluation of a Food Containing Lactic Acid Bacteria to ocular and nasal symptoms of allergy
Acronym
Efficacy Evaluation of a Food Containing Lactic Acid Bacteria to ocular and nasal symptoms of allergy
Scientific Title
Efficacy Evaluation of a Food Containing Lactic Acid Bacteria to ocular and nasal symptoms of allergy
Scientific Title:Acronym
Efficacy Evaluation of a Food Containing Lactic Acid Bacteria to ocular and nasal symptoms of allergy
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of oral administration of a Lactic Acid Bacteria on ocular and nasal symptoms of allergy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
<Efficacy>
The discomfort of eyes and nose in the daily life (Japan Rhinitis Quality of Life Questionnaire No. 1, grading the severity of allergic rhinitis)
Key secondary outcomes
<Efficacy>
Indexes for allergic rhinitis (grading of local findings, eyes and nose condition based on subject's diary, effect measurement), specific measurement of blood, specific measurement of nasal discharge
<Safety>
Blood pressure, pulse, body weight,
body fat percentage, body mass index, hematology test, biochemical test, urinalysis, assessment of adverse events by a medical doctor.
<Other indexes>
Subject's diary, questionnaire for allergic rhinitis, height measurement
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
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
50 mg of Lactic Acid Bacteria, once-daily for 12 weeks
Interventions/Control_2
50 mg of placebo, not including Lactic Acid Bacteria, once-daily for 12 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. Male and Female aged from 20 to 64 years, when giving the informed consent.
2. Healthy individuals not having any chronic diseases.
3. Individuals with allergic reaction of eyes and nose in early spring.
4. Individuals with detectable levels of cedar pollen-specific IgE in serum.
5. Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
6. Individuals who can accomplish their tasks in the study at the appointed date.
7. Individuals who are judged suitable for this study by the investigator.
Key exclusion criteria
1. Individuals who have some diseases with drug therapy.
2. Individuals who use antiallergic drugs or steroid drugs or will use during the test period.
3. Individuals who have history of intranasal laser therapy or sublingual immunotherapy to reduce allergic symptoms.
4. Individuals who are a patient of or have a history of asthma.
5. Individuals who are patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
6. Individuals who consecutively receive drugs for treatment of disease in the last 1 month.
7. Individuals who could have severe allergy to foods or drugs.
8. Individuals who have severe disease histories in liver, kidney, heart, lung, blood or the other tissues.
9. Individuals who are a patient or have a history of endocrine disease.
10. Individuals whose BMI is over 30 kg/m2
11. Individuals who have donated over 200 mL of blood in the last 1 month or 400 mL of blood in the last 3 months.
12. Individuals who cannot stop to ingest yogurt, or drugs or supplements including Lactic acid bacteria or bifidobacterium during the test period.
13. Individuals who had a habit to ingest bifidobacterium-rich foods, health-promoting foods, health foods, or supplements containing similar composition with a test food or will ingest those foods during the test period.
14. Individuals who generally intake alcohol drinks over 60 g/day as the amount of pure alcohol.
15. Individuals who could change their location and their life style during the study, e.g. business trip or traveling for a long time.
16. Individuals who are pregnant, breastfeeding, or planning to be pregnant in the near future.
17. Individuals who participated in other clinical trials in the last 3 months.
18. Individuals who and whose family work for a company manufacturing or selling healthy foods, functional foods.
19. Individuals who are judged unsuitable for this study by the investigator for other reasons.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno-Asagao Clinic
Division name
Director
Zip code
110-0015
Address
Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015 JAPAN
TEL
03-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
Kairaku Building 6F, 2-7-5 Higashiueno Taito-ku Tokyo, 110-0015 JAPAN
TEL
03-6801-8480
Homepage URL
r.shimizu@tes-h.c.jp
Sponsor or person
Institute
TES Holdings Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
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
Human Research Ethics Committee, Kirin Group
Address
4-10-2, Nakano, Nakano-ku, Tokyo
Tel
03-6837-4128
02976_Ni@kirin.co.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
うえのあさがおクリニック (東京都)/ Ueno-Asagao Clinic
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 04 | 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
| 2021 | Year | 12 | Month | 28 | Day |
Last modified on
| 2021 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053059
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