Effect of a Food Containing Lactic Acid Bacteria to Eyes and Nose.

Not Applicable

• Conditions: /A (healthy adults)

• Registration Number: JPRN-UMIN000037329
• Lead Sponsor: TES Holdings Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-10
• Study Start: 2020-11-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

[1]Individuals who visit a hospital or use a drug to treat perennial allergic rhinitis or pollinosis (except using nose drops and eye drops of category-3 OTC). [2]Individuals using medical products. [3]Individuals who are a patient of or have a history of bronchial disease. [4]Individuals who are patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [5]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollinosis). [6]Individuals who are sensitive to a test food. [7]Individuals who are sensitive to foods, and medical products. [8]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease. [9]Individuals who are a patient or have a history of or endocrine disease. [10]Individuals whose BMI is over 30 kg/cm2 [11]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [12]Individuals who have a habit of intaking fermented milk food (over 3 times in a week). [13]Individuals who cannot restrict to eat bactic acid bacteria rich food after informed consent. [14]Individuals who had a habit to ingest bifidobacteria enriched food or food for specified health uses or foods with Function Claims which adopt to ease allergy symptoms in the past 1 month or will ingest those foods during the test period. [15]Individuals who excessively take alcohol expressed in an amount of alcohol over 60g/day. [16]Individuals whose life style will change during the test period. [17]Individuals who are or are possibly pregnant, or are lactating. [18]Individuals who participated in other clinical studies in the past 3 months. [19]Individuals who are or whose family is an employee of a health food company. [20]Individuals judged inappropriate for the study by the principal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[1]The discomfort of eyes and nose in the daily life (JRQLQ NO.1, level of allergic rhinitis, level of local findings, eye- and nose- symptoms based on subject's diary, and effect measurement) (Screening, Week 0, Week 4, Week 8, Week 12, Week 16).