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) studied | N/A (Healthy adults) |
| Date of first enrollment | 2013/09/28 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| 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 Outcome | Salivary IgA and IgA per mg of protein |
|---|---|
| Secondary Outcome | Oral condition and safety |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 40years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1. 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
| Primary Sponsor | Meiji Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Meiji Co., Ltd. |
| Secondary ID(s) |
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 |
| 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 |
| masaki.terahara@meiji.com | |
| Affiliation | Meiji Co., Ltd. R&D Division |