Healthy adult
Conditions
Interventions
Ingestion of the test food and milk for 8 consecutive weeks.
Ingestion of the placebo and milk for 8 consecutive weeks.
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females from 18 to 64 years of age. (2) Subjects who have frequently presence of nasal and ocular discomfort. (3) Subjects whose specific IgE (house dust) is positive. (4) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study.
Exclusion criteria
Exclusion criteria: (1) Subjects who regularly use or have regularly used drugs affecting nasal and ocular symptoms. (Excluding subjects who occasionally use or have occasionally used anti-allergy medicine) (2) Subjects who are constantly using health food affecting nasal and ocular symptoms. (3) Subjects who are constantly using foods or supplements containing lactic acid bacteria, bifidobacteria or oligosaccharide, etc., or foods, medicines, supplements, etc. that affect the intestinal environment, or subjects who cannot stop using them during the test period. (4) Subjects who having a milk allergy or lactose intolerance. (5) Subjects who have serious disease in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, malignant tumors, respiratory disease, or metabolic system etc., or those who have serious medical history of these. (6) Subject who have undergone gastrointestinal surgery. (Excluding adenoids, appendicitis, etc.) (7) Subjects who have chronic digestive symptoms such as diarrhea. (8) Subjects who have asthma. (9) Subjects who are heavy smokers. (Smoking 21 or more cigarettes/day or more) (10) Subjects who drink excessively. (the mean consumption of pure alcohol is 60 g/day or more). (11) Subjects who have medical history of drug allergy or severe food allergy. (12) Subjects who intend to become pregnant or lactating. (13) Subjects who have drawn more than 400mL of blood within 12 weeks prior to the start of intake, or more than 200mL of blood during the pre-observation period. (14) Subjects who participated in another clinical study/research within 1 months before the date of informed consent or who plan to participate in another clinical study/research during the study period. (15) Subjects who are judged as unsuitable for the study by the principal investigator or the investigator for other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nasal and ocular symptom-medication score. | — |
Countries
Japan
Contacts
Public ContactSaki Miyayama
EP Mediate Co., Ltd. Development Department Trial Planning Section
Outcome results
None listed