The Functional Food Containing Lactobacillus and Dietary Fiber for Amelioration of Bowel Movement in Healthy Japanese: A Randomized, Double-blind, Placebo-controlled Study

摘要

Objectives: The objective of this study is to examine how the ingestion of the functional food containing Enterococcus faecalis (EC- BabyM~R) and indigestible dextrin (dietary fiber), "Dietary fiber Nuusankin 5,000 oku-ko" ("DFN") contributes to improve bowel movement.Methods: A randomized, placebo-controlled, double-blind study was conducted to elucidate an effect of food. In this study we measured frequency of bowel movement, days of defecation, volume of stool' fecal properties, and intestinal flora as the primary outcome. We also evaluated blood biochemical parameters as the secondary outcome, and adverse events were collected by means of a written questionnaire during the study. Results: From all of 63 applicants, 8 were eliminated due to not meeting inclusion criteria. 50 subjects were randomly assigned to an intervention group and made a start with ingestion. 22 subjects discontinued due to personal reasons, and the remaining 28 subjects completed the study,1was eliminated because of inadequacy of the records of bowel movement, thus data obtained with 27 subjects (DFN:15, Placebo:12) was used for the analysis of efficacy. After 12-weeks of ingestion, the intergroup analysis showed significant differences in "Frequency of bowel movement", "Days of defecation" and "Bifidobacterium" share in the intestinal flora compared to the Placebo. No adverse events were observed after the ingestion of the test product. Conclusion: We found out that the ingestion of the functional food containing Enterococcus faecalis (EC-BabyM~R) and indigestible dextrin (dietary fiber) for12 weeks improved bowel movement. In addition, no safety-related matter occurred during the 12-week test period.