UMIN-CTR Clinical Trial

Basic information
Public title	The study to confirm the effect of a food containing lactoferrin on oral environment : A randomized, double-blind, placebo controlled trial.
Acronym	The study to confirm the effect of a food containing lactoferrin on oral environment
Scientific Title	The study to confirm the effect of a food containing lactoferrin on oral environment : A randomized, double-blind, placebo controlled trial.
Scientific Title:Acronym	The study to confirm the effect of a food containing lactoferrin on oral environment
Region	Japan

Condition
Condition	None (Healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of ingesting lactoferrin-containing capsules on the factors that would worsen the oral environment , and maintain healthy oral environment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Symptom of gingivitis on anterior teeth Gingival index Plaque index Probing depth Bleeding on probing
Key secondary outcomes	Saliva test:Hb Saliva,LD Saliva,Saliva Secretion,pH Periodontal bacteria number in Saliva(P.gingivalis,P.intermedia,T.forsythensis,T.denticola) Caries-related bacteria number(total Streptococcus,S.mutans,Lactobacillus) Exploratory endpoint Saliva test:Immune index(IL1,IL6,IL8,TNFalpha)

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	Ingestion of 2 capsules containing lactoferrin once a day for 8 weeks
Interventions/Control_2	Ingestion of 2 capsules not containing lactoferrin once a day for 8 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 labial-buccal side of the eight 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) Subject who can avoid taking foods containing lactoferrin, those displaying oral health related indication such as a xylitol chewing gum, and supplements. (7) 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) Subjects who are pregnant, or who are planning to become pregnant or breast-feeding during the test. (4)Persons who are participating or intend to participate in other tests for taking foods, drugs, and/or cosmetics. (5) Subject whose saliva secretion by stimulation during 5 minutes is less than 3.0 mL. (6) Subjects whose pH of saliva is <= 6.2. (7) Subjects who have food allergy. (8) Subjects who are wearing removal dentures. (9) Subjects who are taking antibiotics and/or anti-microbe agents, or who had taken them within one month prior to the screening test. (10) Smoker (11) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Nobuhiro Middle name Last name Hanada
Organization	Tsurumi university, School of Dental Medicine
Division name	Department of translational research
Zip code	230-0063
Address	2-1-3 Tsurumi,Tsurumi-ku, Yokohama-shi, Japan
TEL	045-580-8461
Email	hanada-n@tsurumi-u.ac.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	NRL Pharma, Inc.
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	The ethics committees of Tsurumi University
Address	2-1-3 Tsurumi, Tsurumi-ku, Yokohama- City, Kanagawa Prefecture, Japan
Tel	045-580-8461
Email	Hanada-n@tsurumi-u.ac.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 03 Month 16 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	20
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 02 Month 27 Day
Date of IRB	2020 Year 02 Month 13 Day
Anticipated trial start date	2020 Year 10 Month 07 Day
Last follow-up date	2020 Year 12 Month 06 Day
Date of closure to data entry	2021 Year 02 Month 17 Day
Date trial data considered complete	2021 Year 02 Month 18 Day
Date analysis concluded	2021 Year 03 Month 18 Day

Other
Other related information

Management information
Registered date	2020 Year 03 Month 04 Day
Last modified on	2021 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045056