UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039059 |
|---|---|
| Receipt number | R000044544 |
| Scientific Title | A study to investigate the effects of Bifidobacteria on allergic nasal symptoms: a randomized, double-blind, placebo-controlled, parallel-group comparative study |
| Date of disclosure of the study information | 2020/01/10 |
| Last modified on | 2021/01/07 11:12:23 |
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Basic information
Public title
Study of improvement of allergic nasal symptoms by Bifidobacteria
Acronym
Study of improvement of allergic symptoms by Bifidobacteria
Scientific Title
A study to investigate the effects of Bifidobacteria on allergic nasal symptoms: a randomized, double-blind, placebo-controlled, parallel-group comparative study
Scientific Title:Acronym
Effects of Bifidobacteria on allergic nasal symptoms
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intake of Bifidobacteria on allergic nasal symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nasal symptom score (symptom score, medication score, symptom-medication score)
Key secondary outcomes
Japanese Rhino-conjunctivitis Quality of Life Questionnaire (Items related to the nose)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of food containing Bifidobacteria for 13 weeks
Interventions/Control_2
Ingestion of placebo for 13 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) Healthy men and women aged more than 20 years, less than 65 years.
2) Subject with a history of allergic nasal symptoms in the past 2 years.
3) Subject who is positive for cedar pollinosis-specific IgE (class 2 or higher).
Key exclusion criteria
1) Subject who regularly take or took allergy medicine.
2) Subject with hepatic disease, renal dysfunction, cardiovascular disorder, gastrointestinal disorder, respiratory dysfunction, blood disease, autoimmune disease, endocrine disease, metabolic disease and these severe medical history (Excluding appendectomy).
3) Subject with serious allergy to specific medicine or food.
4) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study.
5) Subject who takes part in other clinical study within the past month.
6) Subject who is ineligible due to physician's judgment.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashikodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
President-director
Zip code
105-0023
Address
Shibaura Omodaka Bldg. 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joutou-machi, Maebashi-shi, Gunma, Japan
Tel
027-261-7600
info@kobunaseikei.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 | 10 | 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
140
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 | 17 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | 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 | 06 | Day |
Last modified on
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044544
