UMIN-ICDS Clinical Trial

Public title

A study to evaluate eye and nose discomfort: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Acronym

A study to evaluate eye and nose discomfort

Scientific Title

A study to evaluate eye and nose discomfort: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

A study to evaluate eye and nose discomfort

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food on the discomfort of the eye and nose in healthy Japanese subjects

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The Japanese allergic rhinitis quality of life questionnaire
2. The grading severity of allergic rhinitis questionnaire

Key secondary outcomes

1. Local findings in nasal cavity
2. Cedar pollen-specific IgE antibody levels
3. Eosinophils, LD(IFCC)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Tablet containing lactic acid bacilli
Administration: Take two tablets daily at any time with water or lukewarm water

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_2

Duration: 12 weeks
Test food: Tablet not containing lactic acid bacilli
Administration: Take two tablets daily at any time with water or lukewarm water

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Japanese
2. Men or women
3. Adults
4. Healthy subjects or those with mild cedar pollen subjects
5. Subjects who have had various symptoms of cedar pollinosis (sneezing, runny nose, stuffy nose, or itchy eyes) in the past two years
6. Subjects who have not developed cedar pollinosis at the time of obtaining consent
7. Subjects who have received a sufficient explanation of the purpose and content of the study, have the ability to consent, have a good understanding of the subject, voluntarily apply for participation, and agree in writing to participate in the study

Key exclusion criteria

1. Subjects receiving treatment for perennial rhinitis
2. Subjects undergoing specific sensitization therapy or surgical therapy for hay fever
3. Subjects who use or take steroidal drugs for drug treatment of hay fever
4. Subjects who reported nasal disease (acute or chronic rhinitis, sinusitis, rhinophyma, hypertrophic rhinitis, or nasal septal deformity)
5. Subjects who have been reported as severe or most severely ill in the severity assessment of allergic rhinitis
6. Subjects suffering from certain diseases except hay fever and receiving outpatient medication
7. Subjects with a history or current history of serious hepatic disorder, renal disorder, cardiac disease, or severe anemia
8. Subjects with a current history of bronchial asthma or those taking anti-allergy medication for atopic dermatitis, asthma, etc.
9. Subjects who may show allergic symptoms to any of the research food ingredients
10. Subjects who who take medicines (such as lactobacillus preparations) that may affect test results, or who routinely consume health foods
11. Subjects with gastrointestinal diseases affecting digestion and absorption, and persons with a history of gastrointestinal surgery
12. Subjects who habitually drink excessive amounts of alcohol, exceeding approximately 60 g of pure alcohol equivalent per day, five or more days per week
13. Subjects with extremely irregular eating habits, shift workers, late-night workers, or those with irregular life rhythms
14. Pregnant, lactating, or intending to become pregnant
15. Subjects who have donated more than 200 mL of blood or component blood within 4 weeks of the screening test or 400 mL within 3 months of the screening test
16. Subjects who have participated in other studies within 1 month of obtaining consent, and those who are willing to participate
17. Subjects who are judged as ineligible to participate in this study by the physician

Target sample size

180

Name of lead principal investigator

1st name	Tohru
Middle name
Last name	Sagami

Organization

Doctor

Division name

Shinagawa Season Terrace Health Care Clinic

Zip code

108-0075

Address

1-2-70, Konan, Minato-ku, Tokyo. The 5th floor of Shinagawa season terrace

TEL

03-3452-3382

Email

shibaura@sempos.or.jp

Name of contact person

1st name	Yoshika
Middle name
Last name	Komori

Organization

KSO Corporation

Division name

Clinical Trial Management department

Zip code

105-0023

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL

Email

eigyou27@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

Asahi Group Foods, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee of Kobuna Orthopedics Clinic

Address

5-656-17 Joto-machi, Maebashi-shi, Gumma

Tel

027-212-5608

Email

sagawa@mc-connect.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2022

Year

11

Month

10

Day

Date of IRB

2022

Year

11

Month

10

Day

Anticipated trial start date

2023

Year

01

Month

14

Day

Last follow-up date

2023

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

12

Month

23

Day

Last modified on

2023

Year

06

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056812