UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028407
Receipt number R000032520
Scientific Title The study to confirm the effect of a food containing lactic acid bacteria on oral health : A randomized, double-blind, placebo controlled trial.
Date of disclosure of the study information 2018/12/23
Last modified on 2022/07/19 16:53:48

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Basic information

Public title

The study to confirm the effect of a food containing lactic acid bacteria on oral health : A randomized, double-blind, placebo controlled trial.

Acronym

Effect of a food containing lactic acid bacteria on oral health.

Scientific Title

The study to confirm the effect of a food containing lactic acid bacteria on oral health : A randomized, double-blind, placebo controlled trial.

Scientific Title:Acronym

Effect of a food containing lactic acid bacteria on oral health.

Region

Japan


Condition

Condition

None (Healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to confirm the efficacy of the continuous intake of a food containing lactic acid bacteria on oral health.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Gingival index
Plaque index

Key secondary outcomes

Symptom of gingivitis on anterior teeth
Periodontal index
Saliva test: anti-microbial peptide (beta-defensin 1), hemoglobin content, LD (LDH) content, saliva secretion, pH, immune index (IgA, IL1, IL6, IL8, TNF-alpha)
Periodontal bacteria number (P. gingivalis, P. intermedia, T. forsythensis, F. nucleatum )
Caries-related bacteria number (total Streptococcus, S. mutans ) VSC concentration (hydrogen sulfide, methyl mercaptan, dimethyl sulfide)
Special blood test: immune index (IgA, IL1, IL6, IL8, TNF-alpha)


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

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingest the yogurt drink containing lactic acid bacteria LH strain every day for 12 weeks.

Interventions/Control_2

Ingest the yogurt drink without lactic acid bacteria LH strain every day for 12 weeks.

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 aged between 20 to 65 years old.
(2) Subjects who generally take three meals a day.
(3) Subject who have more than four teeth possible to examine out of the lavial-buccal side of the six teeth including maxillary right first molar (FDI tooth number 16), maxillary right lateral incisor (12), maxillary left central incisor (21), maxillary left first premolar (24), mandibular left lateral incisor (32), mandibular left first molar (36), mandibular right central incisor (41), and mandibular right first premolar (44). Instead of the subjects as mentioned above, subjects having FDI number 17, 15, 11, 22, 25, 37, 35, 31, 42, and 45 are also applicable.
(4) Subjects who have gingivitis or at least one periodontal pocket more than 4 mm depth.
(5) Subjects who are not receiving treatment for caries and periodontal disease, and have at least 20 teeth new.
(6) Subjects periodontal disease-associated bacteria were detected by the screening test.
(7) Subject who can avoid taking foods containing lactic acid bacteria, those displaying oral health related indication such as a xylitol chewing gum, and supplements.
(8) Subjects who received a sufficient explanation of the purpose and contents of this examination, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.

Key exclusion criteria

(1) Subject who are diagnosed with caries (C3<=) or severe periodontal disease.
(2) Subject who have illness such as diabetes, chronic kidney disease, gastrointestinal disease, lung disease, malignant tumor and so on, and are taking medicine.
(3) Persons who are participating or intend to participate in other tests for taking foods, drugs, and/or cosmetics.
(4) Subject whose saliva secretion by stimulation during 5 minute is less than 3.0 mL.
(5) Subjects whose pH of saliva is <= 6.2.
(6) Subjects who are wearing removal dentures.
(7) Subjects who are taking antibiotics and/or anti-microbe agents, or who had taken them within one month prior to the screening test.
(8) Subjects who have food allergy, lactose intolerance, and/or feeling of unwellness by the dairy products.
(9) Subjects who are pregnant, or who are planning to become pregnant or breast-feeding during the test.
(10) Subjects who are judged as unsuitable for the study by the investigator for other reasons.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuhiro Hanada

Organization

Tsurumi university, School of Dental Medicine

Division name

Department of translational research

Zip code


Address

2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, 230-0063, Japan

TEL

045-580-8461

Email

hanada-n@tsurumi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiji Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code


Address

1-9-7 Shibaura, Minato-ku, Tokyo, 105-0023, Japan

TEL

03-3452-7733

Homepage URL


Email

yoshikawa@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

MEGMILK SNOW BRAND 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


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

鶴見大学歯学部探索歯学講座(神奈川県)
Tsurumi university, School of Dental Medicine, Department of translational research (Kanagawa)


Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 23 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 07 Month 25 Day

Date of IRB

2017 Year 07 Month 25 Day

Anticipated trial start date

2017 Year 07 Month 29 Day

Last follow-up date

2017 Year 12 Month 24 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 07 Month 27 Day

Last modified on

2022 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032520


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name