UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029968 |
|---|---|
| Receipt number | R000033917 |
| Scientific Title | Clinical research on the effect of induing the secretion of s-IgA in saliva on Leuconostoc mesenteroides NTM048 strain |
| Date of disclosure of the study information | 2017/11/15 |
| Last modified on | 2020/02/06 14:51:45 |
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Basic information
Public title
Clinical research on the effect of induing the secretion of s-IgA in saliva on Leuconostoc mesenteroides NTM048 strain
Acronym
Clinical research on the effect of induing the secretion of s-IgA in saliva on Leuconostoc mesenteroides NTM048 strain
Scientific Title
Clinical research on the effect of induing the secretion of s-IgA in saliva on Leuconostoc mesenteroides NTM048 strain
Scientific Title:Acronym
Clinical research on the effect of induing the secretion of s-IgA in saliva on Leuconostoc mesenteroides NTM048 strain
Region
| Japan |
Condition
Condition
Cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the secretion promoting effect of s-IgA in saliva by lactic acid bacteria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of s-IgA secreation
Key secondary outcomes
(1)Time course of s-IgA in saliva
(2)Number of infections of influenza and viral emesis diarrhea
(3)POMS 2 (mood profile test)
(4)Stool frequency
(5)Characteristics of stool
(6)Organic acid in stool
(7)Bacterial flora in stools
The evaluation items below are done in the cedar pollinosis group
(8)Specific IgE (cedar) concentration in blood
(9)Nasal symptom score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take two capsules containing lactic acid bacteria a day
Interventions/Control_2
Take two placebo capsules a 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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Adult male and female from 20 to 60 years old
(2) Subjects who can take capsules
Key exclusion criteria
(1) Subjects with symptoms of hay fever except cedar pollinosis at the stage of screening conducted from November 2017 to January 2018
(2) Subjects who regularly drink or eat live fungus-containing foods including lactic acid bacteria beverage, food,and preparation, and Bacillus natto
(3) Subjects smorking
(4) Pregnant women, lactating women, or women who want to get pregnant during the trial period
(5)Subjects who show hypersensitivity symptoms to lactic acid bacteria foods
(6) Subjects who investigator judge not suitable to participate in the trial
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gen Sugita |
Organization
Wakayama Medical University School of Medicine
Division name
Department of Otolaryngology
Zip code
Address
811-1 Kimiidera, Wakayama 641-8509, Japan
TEL
073-447-2300
genent@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuta Yamamoto |
Organization
Wakayama Medical University School of Medicine
Division name
Department of Anatomy and Cell Biology
Zip code
Address
811-1 Kimiidera, Wakayama 641-8509, Japan
TEL
073-441-0616
Homepage URL
yuta-y@wakayama-med.ac.jp
Sponsor or person
Institute
Department of Otolaryngology, Wakayama Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nitto Pharmaceutical Industries, LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 11 | Month | 15 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 07 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 08 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 14 | Day |
Last modified on
| 2020 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033917
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
