UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039309
Receipt number R000044718
Scientific Title Effects of a Test Food for Allergic Reaction of Eyes or Nose.
Date of disclosure of the study information 2020/01/31
Last modified on 2021/06/25 09:36:30

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Basic information

Public title

Effects of a Test Food for Allergic Reaction of Eyes or Nose.

Acronym

Effects of a Test Food for Allergic Reaction of Eyes or Nose.

Scientific Title

Effects of a Test Food for Allergic Reaction of Eyes or Nose.

Scientific Title:Acronym

Effects of a Test Food for Allergic Reaction of Eyes or Nose.

Region

Japan


Condition

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to examine effects of a test food for allergic reaction of eyes or nose.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[1]Indexes for allergic rhinitis (Japan Rhinitis Quality of Life Questionnaire No. 1(1), grading the severity of allergic rhinitis(2), grading of local findings(2), eyes and nose condition based on subject's diary(3), effect measurement(4))
(1):Week 0, 3, 6.
(2):Week 0, 6.
(3)From the first day of ingestion of a test material to the last day of the test.
(4)Week 6.

Key secondary outcomes

*Secondary outcomes
[1]Specific measurementf of nasal discharge and blood (nasal discharge eosinophils, eosinophil, nonspecific IgE, specific IgE) (Week 0, 6).
[2]Metabolome analysis for bacterial flora metabolism (Week 0, 6).

*Safety evaluation
[1]Hematologic test (Week 0, 6).
[2]Blood biochemical (Week 0, 6).
[3]Urine analysis (Week 0, 6).
[4]Blood pressure, pulsation (Week 0, 6).
[5]Weight, body fat percentage, BMI (Week 0, 6).
[6]Doctor's questions (Week 0, 6).

*Other indexes
[1]Questionnaire for allergic rhinitis (Week 0).
[2]Subject's diary (From the first day of ingestion of a test material to the last day of the test).


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of the test food (2 capsules in a day; 6 weeks).

Interventions/Control_2

Oral intake of the placebo food (2 capsules in a day; 6 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]Japanese males and females aged 20-64 years.
[2]Individuals who are healthy and are not suffered from a chronic malady.
[3]Individuals with allergic reaction of eyes and nose in early spring.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals who use an antiallergic drug or steroid drug or will use during the test period.
[3]Individuals who have history of intranasal laser therapy to reduce allergic symptoms.
[4]Individuals who are a patient of or have a history of bronchial disease.
[5]Individuals who are patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[6]Individuals who used a drug to treat a disease in the past 1 month.
[7]Individuals who are sensitive to dairy products or lactose intolerance.
[8]Individuals who are sensitive to other foods and medical products.
[9]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease.
[10]Individuals who are a patient or have a history of or endocrine disease.
[11]Individuals whose BMI is over 30 kg/m2.
[12]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[13]Individuals who have a habit to ingest fremented milk food over 3 times in a week.
[14]Individuals who cannot stop to ingest lactobacillus-rich foods after signed an informed consent.
[15]Individuals who had a habit to ingest lactobacillus-rich foods, health-promoting foods, fhealth foods, or supplements containing similar composition with a test food in the past 1 month or will ingest those foods during the test period.
[16]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60 mg/day).
[17]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[18]Individuals who are or are possibly, or are lactating.
[19]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[20]Individuals who are or whose family is engaged in healthy or functional foods.
[21]Individuals judged inappropriate for the study by the principal.

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Takahiro
Middle name
Last name Ono

Organization

Ueno-Asagao Clinic

Division name

Head

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6240-1162

Email

info@ueno-asagao.clinc


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

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL


Email

r.shimizu@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Miyako Kagaku Co,. Ltd.

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

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

+81-3-6240-1162

Email

jimukyoku@tes-h.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



Other administrative information

Date of disclosure of the study information

2020 Year 01 Month 31 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

2019 Year 12 Month 20 Day

Date of IRB

2019 Year 12 Month 23 Day

Anticipated trial start date

2020 Year 02 Month 14 Day

Last follow-up date

2020 Year 03 Month 29 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 29 Day

Last modified on

2021 Year 06 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044718


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name