All 44 subjects completed the treatment protocol.
Their entry characteristics at week 0 are summarised by treatment allocation in Table 1. The
treatment groups were generally well matched,
except for a small difference in HDL cholesterol
and a non-significant difference in body mass
index. Three subjects reported constipation and
increased flatus, one on placebo and two on Lactobacillus. Based on a count of returned capsules at
study closure, all subjects except one consumed
more than 75% of the amount dispensed. One
subject complaining of increased flatus on Lactobacillus halved intake over the final two weeks
of study.
Table 2 summarises the key lipid and lipoprotein outcomes. Total and LDL cholesterol levels
did not change significantly over time, (based on
examination of confidence intervals), but there
was modest downward trend on both arms of
treatment. Mean LDL cholesterol was 5.2% lower
on placebo and 7.0% lower on Lactobacillus, but
with no significant difference between treatments. HDL cholesterol trended slightly lower on
both arms, but with no significant difference
over time or between treatments. There were no
significant changes in triglycerides or differences
between treatments.
The percentage change in LDL cholesterol was
evaluated in those below and above the week
0 median LDL cholesterol of 3.95 mmol/L. In those
with lower LDL cholesterol, LDL cholesterol showed
a 0.1% (95% confidence interval 24 to þ18) fall on
placebo and a 3.3% (16 to þ11) fall on Lactobacillus. In those with higher LDL cholesterol, LDL
cholesterol showed a 10.7% (27 to 1.2) fall on
placebo and a 10.4% (31 to þ1.2) fall on
Lactobacillus.
The changes in liver enzymes, glucose, creatinine and CRP between week 0 and week 8 are
summarised in Table 3. There were no significant
changes over time or between treatment arms.
Body weights did not change significantly over
the study duration.
Discussion
Although LDL cholesterol trended downwards on
both treatment arms over the 10 weeks of treatment, this placebo-controlled evaluation demonstrated no significant effect of Lactobacillus
fermentum in the dose selected on total or LDL
cholesterol, HDL cholesterol or serum triglycerides. We cannot exclude an effect from a still
higher dose, but this approach would most likely
be limited by potential adverse effects. There
were already 3 out of 46 subjects reporting bowel
side effects at the present dose.
Table 1 Baseline characteristics by treatment group
Placebo
(n ¼ 21)
Lactobacillus