UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058174 |
|---|---|
| Receipt number | R000066503 |
| Scientific Title | Effect of probiotics on symptoms of perennial allergic rhinitis. A randomized, Double-blind, placebo-controlled study |
| Date of disclosure of the study information | 2025/06/13 |
| Last modified on | 2025/06/13 19:42:38 |
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Basic information
Public title
Effect of probiotics on symptoms of perennial allergic rhinitis. A randomized, Double-blind, placebo-controlled study
Acronym
Effect of probiotics on symptoms of perennial allergic rhinitis. A randomized, Double-blind, placebo-controlled study
Scientific Title
Effect of probiotics on symptoms of perennial allergic rhinitis. A randomized, Double-blind, placebo-controlled study
Scientific Title:Acronym
Effect of probiotics on symptoms of perennial allergic rhinitis. A randomized, Double-blind, placebo-controlled study
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate effect of probiotics on symptoms of perennial allergic rhinitis for healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Nasal and ocular symptom-medication score.
Key secondary outcomes
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
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test food and milk for 8 consecutive weeks.
Interventions/Control_2
Ingestion of the placebo and milk for 8 consecutive 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
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Beppu |
Organization
Medical Corporation Hirookai
Division name
Nishi-Tokyo Sakura Clinic
Zip code
188-0011
Address
4th Floor, 2-16-10 Tanashi-cho, Nishi-Tokyo, Tokyo, Japan
TEL
042-497-6035
beppu-ind@umin.ac.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Miyayama |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo,
TEL
070-3023-8210
Homepage URL
miyayama.saki392@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga milk industry co.,ltd
R&D Division, Food Function Research institute
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakajima.megumi888@eps.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
医療法人社団 浩央会 西東京さくらクリニック（東京都）
Medical Corporation Hirookai Nishi-Tokyo Sakura Clinic（Tokyo）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 13 | 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
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2025 | Year | 06 | Month | 13 | Day |
Last modified on
| 2025 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066503
