TITLE:
Randomized, Double Blind and Placebo Controlled Study Using a Combination of Two Probiotic Lactobacilli to Alleviate Symptoms and Frequency of Common Cold
AUTHORS:
Regina Busch, Joerg Gruenwald, Steffi Dudek
KEYWORDS:
Probiotics; Lactobacillus plantarum HEAL9; Lactobacillus paracasei 8700:2; Immune; Common cold; Clinical Study
JOURNAL NAME:
Food and Nutrition Sciences,
Vol.4 No.11A,
November
1,
2013
ABSTRACT: Purpose: The efficacy of
ProbiDefendum, a combination of the two lactobacilli Lactobacillus plantarum HEAL9 and Lactobacillus paracasei 8700:2, on the severity, duration and
frequency of cold episodes was studied in a randomized, double blind, placebo
controlled clinical trial. Methods: A total of 310 subjects
with increased risk for common cold infection (at least two episodes of common
cold during the last six months) were enrolled and were randomly assigned to
receive either active product (A-group) or placebo (P-group) over a period of
12 weeks. Subjects reported the occurrence and severity of cold episodes in a
diary, scoring 13 different symptoms of common cold over a period of 7 days
after the episode began. Results: In
the total study population, cold episodes were reported in 148 cases (47.7%).
In the A-group, 54 subjects acquired one and 18 subjects acquired 2 episodes
whereas 83 subjects had none. In the P-group, 52 subjects reported one, 24
subjects reported 2 episodes and 79 subjects reported none. Although the number
of episodes was similar in both groups, cold episodes in the active group were
significantly shorter than in the placebo group. The total sum scores of cold
symptoms were significantly lower in the active group as compared with the
placebo group, as well as in the intention-to-treat (ITT) as in the
per-protocol (PP) collectives (ITT: 75.2 ± 40.3 vs. 113.4 ± 66.3; p 0.001; PP:
73.1 ± 38.8 vs. 117.0 ± 66.1; p 0.001). The daily ingestion of the probiotics over
a period of 12 weeks was well tolerated. Conclusion: The daily intake of the probiotic
dietary supplement ProbiDefendum over a period of 12 weeks efficiently
alleviated symptoms of common cold and the duration of cold episodes.