TITLE:
Safety Evaluations of Long-Term and Excessive Intakes of Bifidobacterium longum CLA8013: A Placebo-Controlled, Randomized, Double-Blind Study
AUTHORS:
Daisuke Takami, Keisuke Okada, Yutaka Makizaki, Yoshiki Tanaka, Hiroshi Ohno, Daisuke Tsuge
KEYWORDS:
Constipation, Safety, Bifidobacterium longum, Long-Term, Excessive
JOURNAL NAME:
Food and Nutrition Sciences,
Vol.14 No.10,
October
31,
2023
ABSTRACT: Heat-killed Bifidobacterium
longum CLA8013 has been demonstrated to improve the frequency of defecation, straining, and pain during defecation in human placebo-controlled,
double-blind, parallel-group studies. We conducted a randomized, double-blind, placebo-controlled,
parallel-group study to evaluate the safety of both long-term and
excessive intakes of heat-killed B.
longum CLA8013, when used as a food with functional claims. In both tests, 30 healthy
volunteers were divided into two groups: an active group that
ingested heat-killed B. longum CLA8013 and a placebo group. In the long-term intake
safety study, participants in the active group ingested 25 billion
cells/day for 12 weeks. In the excessive intake safety study, participants in
the active group ingested 125 billion cells/day for 4 weeks. Physical,
hematological, biochemical, and urine examinations were conducted, and adverse events were evaluated in both studies. The studies
revealed no
abnormalities in any of the safety tests. In conclusion, no safety-related issues
were identified with long-term or excessive intake of
heat-killed B. longum CLA8013.