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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000020795
Date of registration:	29/01/2016
Prospective Registration:	Yes
Primary sponsor:	Department of Oral Biology & Engineering, Integrated Health Sciences, Institute of Biomedical and Health Sciences, Hiroshima University
Public title:	Colonization of Lactobacillus rhamnosus L8020 in the oral cavity after intake of L8020-containing tablets
Scientific title:	Colonization of Lactobacillus rhamnosus L8020 in the oral cavity after intake of L8020-containing tablets - Oral colonization of Lactobacillus rhamnosus L8020
Date of first enrolment:	2016/03/01
Target sample size:	50
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023672
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Tsuyoshi Taji
Address:	1-2-3 Kasumi, Minami-ku, Hiroshima Japan
Telephone:	082-257-5797
Email:	taji@hiroshima-u.ac.jp
Affiliation:	Integrated Health Sciences, Institute of Biomedical and Health Sciences, Hiroshima University Department of Oral Biology & Engineering

Name:	Hiroki Nikawa
Address:	1-2-3 Kasumi, Minami-ku, Hiroshima Japan
Telephone:	082-257-5797
Email:	hirocky@hiroshima-u.ac.jp
Affiliation:	Integrated Health Sciences, Institute of Biomedical and Health Sciences, Hiroshima University Department of Oral Biology & Engineering

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1. Subject with allergy to dairy products 2. Subject with a history of antibiotic treatment within a month before experiment 3. Subject who may receive treatments of topical fluoride or povidone-iodine during experiment period

Age minimum: 20years-old
Age maximum: 100years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Healthy adults

Intervention(s)

Volunteers ingest three L8020-containing tablets everyday after lunch for two weeks

Primary Outcome(s)

PCR detection for Lactobacillus in stimulated saliva 7 days before and 2, 7 and 14 days after intervention

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Grants-in-aid for Scientific Research

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date: 15/03/2017
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	31/03/2018
URL:

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