UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039691 |
|---|---|
| Receipt number | R000045056 |
| Scientific Title | The study to confirm the effect of a food containing lactoferrin on oral environment : A randomized, double-blind, placebo controlled trial. |
| Date of disclosure of the study information | 2020/03/16 |
| Last modified on | 2021/03/29 11:08:02 |
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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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045056
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| Registered date | File name |
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