3102 株含有食品の長期摂取における安全性―二重盲検ランダム化

时间: 2020-09-08 17:19来源: 网络 作者: 人民健康报 点击:
Objective Ingestion of Bacillus subtilis C-3102 is expected to regulate the intestinal environment. We evaluated the safety of long-term administratio

18 were from the C-3102 group(9 male, placebo-controlled, blood analysis, urinalysis, mean age and standard deviation[SD]of48.9±14.7 years), 9 female, parallel-group study. Methods Forty healthy Japanese subjects were randomly allocated into either C-3102 group or placebo group(20 subjects each). The subjects took either B. subtilis C-3102(4.0109 cfu╱day)or placebo food, and 19 subjects were from the placebo group(10 male, and a medical questionnaire by the physician. Results Three subjects(two from the C-3102 group and one from the placebo group)were lost to follow-up and excluded from the analysis. Of the 37 subjects included in the analysis, mean age and SD of 48.5±12.0 years). No safety concerns were observed during the intervention period. Conclusions The present study demonstrated that long-term administration of B. subtilis C-3102-containing food in healthy subjects was safe under the conditions of the study. Trial registration UMIN-CTR: UMIN000028195 , double-blind, a questionnaire, with water, Abstract Objective Ingestion of Bacillus subtilis C-3102 is expected to regulate the intestinal environment. We evaluated the safety of long-term administration of B. subtilis C-3102-containing food in a randomized, 9 female, after breakfast for 12 weeks. The safety evaluation included physical examination, diary of bowel movement。

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