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Results
of Clinical Trials
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| Lactobacillus F19 has been
thoroughly researched. Not only is the probiotic culture well tolerated
by children, adults, and the elderly, but research has shown that F19
has the ability to colonize the lower GI tract. Sullivan et al (2002) studied the impact of F19 in 35 elderly adults testing seropositive for Helicobacter pylori. Volunteers were randomized into control (n = 18), and treatment (n = 17) groups and were blind to the treatment regimen. Control adults consumed 1.5 dL of a fermented milk product twice daily for 12 weeks. Adults allotted to the treatment group consumed the same volume of fermented milk. However, the milk contained 350 million (3.5 x 108) cfu's of F19 per mL and 2% inulin, with a total daily administration of more than 100 billion (1 x 1011) cfu's of F19 per day. Fecal samples were taken on day 0 and at weeks 4, 12, and 20. Samples were enumerated for F19, total lactobacilli and total bifidobacteria. Median values of the logarithmic numbers of colony formin units (cfu's) of F19 per gram of feces are shown in Figure 6. One of the 17 treated adults hosted a natural population of F19 on day 0. However, there was a multi-logarithmic statistically significant increase of F19 cfu's after 4 weeks of supplementation (P < 0.01). Results for samples taken at 12 weeks showed the concentration of Lactobacillus F19 in the gut had stabilized. Eight weeks after supplementation ended, 2 out of 17 treatment volunteers had measurable quantities of F19 in their fecal samples. However, Lactobacillus F19 virtually decreased in number when supplementation ceased, behaving more like a real probiotic candidate should; increasing in number when supplemented and phasing out of the intestinal microbial population when it wasn't. |
The treatment containing
Lactobacillus F19 also had a favorable
impact on other non-F19 lactobacilli. There
was a
statistically significant increase in non-F19 lactobacilli (P
< 0.01) when week 4 fecal sample numbers were compared to day 0
numbers. Treatment volunteers hosted nearly a 2 log in other Lactobacillus species. However, the
number of bifidobacteria were unaffected by treatment. Results indicate
that Lactobacillus F19
survives passage through the GI tract and is established as a significant
microbial population, making it an ideal probiotic culture. In yet another study, Sullivan et al (2002) reported similar results from a trial initially involving 61 children. In a double-blind study, every other child was assigned to a placebo (negative control) group or a treatment group. Placebos consisted of gelatin capsules containing 0.3 grams of corn starch. Treatment capsules contained an added 10 billion (1 x 1010) cfu's of freeze-dried F19. Each group was given their respective capsules twice daily, mixed in food for 3 weeks (2 x 1010 total cfu's per day). Fecal samples were collected prior to initiation of the trial, between weeks 2 and 3, and at 5 weeks, 2 weeks after supplementation stopped. The placebo group mean age and standard deviation were 13.6 months + 2 months (n = 30). For the treatment group, the mean age and standard deviation 12.5 months and 1.4 months (n = 31), respectively. Lactobacillus F19 numbers significantly increased in the fecal samples with supplementation (2-3 week sample) when compared to day 0 counts. Six of 30 treatment children hosted significant numbers of F19 2 weeks after the study concluded. Results showed that F19 was well tolerated by children and F19 survived passage through the gut, thereby corroborating the results obtained in elderly adults. |
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Figure 6. Fecal counts of Lactobacillus F19 in elderly treatment participants.
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