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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043042
Receipt No. R000049140
Scientific Title Study on the relationship between oral volatile sulfur compounds and chewy foods containing lactic acid bacteria.
Date of disclosure of the study information 2021/01/19
Last modified on 2021/08/10

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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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 01 Month 18 Day
Last modified on
2021 Year 08 Month 10 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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