UMIN-CTR Clinical Trial

Basic information
Public title	Study on the relationship between oral volatile sulfur compounds and chewy foods containing lactic acid bacteria.
Acronym	Study on the relationship between breath odors and chewy foods containing lactic acid bacteria.
Scientific Title	Study on the relationship between oral volatile sulfur compounds and chewy foods containing lactic acid bacteria.
Scientific Title:Acronym	Study on the relationship between breath odors and chewy foods containing lactic acid bacteria.
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Medicine in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of ingestion of chewy foods containing lactic acid bacteria on the generation of volatile sulfur compounds during masking. At the same time, changes in physical condition, etc. will be confirmed in order to understand the improvement of immune-related QOL.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of change in oral gas concentration.
Key secondary outcomes	Analysis of oral flora (e.g. correlation with volatile sulfide compounds). Immune-related changes in quality of life.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Food containing active ingredients, 4pieces /day, 28 consecutive days.
Interventions/Control_2	Food without active ingredients, 4pieces /day, 28 consecutive days.
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) Subjects who gave written informed consent to participate in the study. 2) Individuals who are diagnosed as having no health problems based on a physician's interview. 3) Men and women aged 20-65 years at the time of informed consent. 4) Non-smokers for at least 1 year. 5) Persons who have not undergone dental treatment or cleaning by a dentist within 6 months retrospectively from the date of the screening examination. 6) Those who have 24 or more teeth left behind.
Key exclusion criteria	1) Pregnant women or women of childbearing potential, and women who wish to become pregnant during the study period. 2) Lactating women. 3) Persons with a history of serious disease (including Sjoegren's syndrome). 4) Persons with a history of hypersensitivity to gelatin or sugar alcohols. 5) Persons who may require dental treatment (including orthodontic treatment) during the study participation period. 6) Persons who has undergone extraction procedures other than tooth extraction for convenience in wisdom tooth extraction or orthodontic treatment. 7) Patients who have taken antibiotics (antibiotics/antibiotics) within 3 months. 8) Persons who may use antihistamines (due to hay fever, allergies, etc.) during the study period (use of antihistamines and cold medications will be investigated in a pre-questionnaire or diary). 9) Persons who do not show an increase in oral gas concentration after wearing a mask in the measurement of oral gas concentration during screening. 10) Other persons who the investigator or the investigator judges to be inappropriate as subjects of the study.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Saito
Organization	Otsuka Pharmaceutical,Co.,Ltd.
Division name	Otsu Nutraceuticals Research Institute
Zip code	520-0002
Address	3-31-13, Saikawa, Otsu-shi, Shiga 520-0002, Japan
TEL	077-521-8835
Email	Saito.Hiroshi@otsuka.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Saito
Organization	Otsuka Pharmaceutical,Co.,Ltd.
Division name	Otsu Nutraceuticals Research Institute
Zip code	520-0002
Address	3-31-13, Saikawa, Otsu-shi, Shiga 520-0002, Japan
TEL	077-521-8835
Homepage URL
Email	Saito.Hiroshi@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical,Co.,Ltd.
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical,Co.,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	Japan Conference of Clinical Research
Address	Ikebukuro YS Bldg. 8F, 1-13-23 Minami-ikebukuro, Toshima-ku, Tokyo 171-0022,Japan
Tel	03-6868-7022
Email	ishii-keiko@3hcts.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

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 19 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	2021 Year 01 Month 05 Day
Date of IRB	2020 Year 12 Month 18 Day
Anticipated trial start date	2021 Year 02 Month 08 Day
Last follow-up date	2021 Year 03 Month 13 Day
Date of closure to data entry	2021 Year 05 Month 27 Day
Date trial data considered complete	2021 Year 05 Month 27 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 18 Day
Last modified on	2022 Year 08 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049140