UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042297
Receipt number R000048288
Scientific Title SP1665
Date of disclosure of the study information 2020/10/30
Last modified on 2022/08/25 09:40:48

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Basic information

Public title

Study on the relationship between oral volatile sulfur compounds and lactic acid bacteria.

Acronym

Study on the relationship between bad breath and Lactobacillus.

Scientific Title

SP1665

Scientific Title:Acronym

SP1665

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To understand the kinetics of volatile sulfur compound generation in the human oral cavity while wearing a mask, and to study the effect of intake on the generation of volatile sulfur compounds.

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).


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) 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

Beverage containing an ingredient.

Interventions/Control_2

Beverage without any ingredients.

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 who may require dental treatment (including orthodontic treatment) during the study participation period.
5) Persons who has undergone extraction procedures other than tooth extraction for convenience in wisdom tooth extraction or orthodontic treatment.
6) Patients who have taken antibiotics within 3 months.
7) 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).
8) Persons who do not show an increase in oral gas concentration after wearing a mask in the measurement of oral gas concentration during screening.
9) 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 or person

Institute

Otsuka Pharmaceutical,Co.,Ltd.

Institute

Department

Personal name



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

2020 Year 10 Month 30 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

2020 Year 10 Month 23 Day

Date of IRB

2020 Year 10 Month 16 Day

Anticipated trial start date

2020 Year 11 Month 05 Day

Last follow-up date

2021 Year 02 Month 28 Day

Date of closure to data entry

2021 Year 04 Month 27 Day

Date trial data considered complete

2021 Year 04 Month 27 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 10 Month 30 Day

Last modified on

2022 Year 08 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048288


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name