UMIN-CTR Clinical Trial

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
Email	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
Email	yuta-y@wakayama-med.ac.jp

Sponsor
Institute	Department of Otolaryngology, Wakayama Medical University School of Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033917