NIPH Clinical Trials Search

JAPANESE
UMIN ID: UMIN000053172

Registered date:20/12/2023

Effects of ingesting heat-killed bifidobacteria for 5 weeks on the oral condition

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedN/A (Healthy adults)
Date of first enrollment2013/09/28
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Test food: One g of granule dextrin contained 40 mg of non-live bifidobacteria powder (more than 0.5 x 10^10 non-live cells per 1 g of the test food) Administration: Oral intake of test food twice a day for 5 weeks Placebo food: One g of granule dextrin Administration: Oral intake of placebo food twice a day for 5 weeks

Outcome(s)

Primary OutcomeSalivary IgA and IgA per mg of protein
Secondary OutcomeOral condition and safety

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum40years-old
GenderFemale
Include criteria
Exclude criteria1. Subjects with severe caries or periodontal disease 2. Subjects with removable dentures 3. Subjects who have took in antibiotic or antibacterial agent within the last month to the screening test 4. Pregnant, possibly pregnant during this study, or lactating women 5. Subjects with sever systemic diseases affecting the results of this study

Related Information

Contact

public contact
Name Eiji Yoshikawa
Address 7F Shibaura Omodaka Bldg. 1-9-7 Shibaura, Minato-ku, Tokyo Japan 105-0023
Telephone 81-3-3452-7733
E-mail eigyou27@kso.co.jp
Affiliation KSO Corporation Clinical Trial Management department
scientific contact
Name Masaki Terahara
Address 1-29-1 Nanakuni, Hachiouji, Tokyo, Japan Japan
Telephone 81-42-632-5846
E-mail masaki.terahara@meiji.com
Affiliation Meiji Co., Ltd. R&D Division