Randomized, Double Blind and Placebo Controlled Study Using a Combination of Two Probiotic Lactobacilli to Alleviate Symptoms and Frequency of Common Cold

Regina Busch, Joerg Gruenwald, Steffi Dudek

Analyze & Realize GmbH, Berlin, Germany.
Analyze & Realize GmbH, Berlin, Germany..

DOI: 10.4236/fns.2013.411A003                

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.

Keywords

Probiotics; Lactobacillus plantarum HEAL9; Lactobacillus paracasei 8700:2; Immune; Common cold; Clinical Study

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	J. E. Linder, et al., “Human Rhinovirus C: Age, Season, and Lower Respiratory Illness over the Past 3 Decades,” The Journal of allergy and clinical immunology, Vol. 131, No. 1, 2013, pp. 69-77,e61-66.
[2]	R. Eccles, “Understanding the Symptoms of the Common Cold and Influenza,” The Lancet Infectious Diseases, Vol. 5, No. 11, 2005, pp. 718-725. http://dx.doi.org/10.1016/S1473-3099(05)70270-X
[3]	J. Hellgren, A. Cervin, S. Nordling, A. Bergman and L. O. Cardell, “Allergic Rhinitis and the Common Cold—High Cost to Society,” Allergy, Vol. 65, No. 6, 2010, pp. 776783. http://dx.doi.org/10.1111/j.1398-9995.2009.02269.x
[4]	“Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria,” Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food including Powder Milk with Live Lactic Acid Bacteria, Cordoba, October 1-4, 2001, pp. 1-34.
[5]	M. L. Ritchie and T. N. Romanuk, “A Meta-Analysis of Probiotic Efficacy for Gastrointestinal Diseases,” PLoS One, Vol. 7, No. 4, 2012, Article ID: e34938. http://dx.doi.org/10.1371/journal.pone.0034938
[6]	S. Guandalini, et al., “Lactobacillus GG Administered in Oral Rehydration Solution to Children with Acute Diarrhea: a Multicenter European Trial,” Journal of Pediatric Gastroenterology and Nutrition, Vol. 30, No. 1, 2000, pp. 54-60. http://dx.doi.org/10.1097/00005176-200001000-00018
[7]	K. Hatakka, “Probiotics and the Prevention of Clinical Manifestation of Common Infectious Diseases in Children and in the Elderly,” Ph.D. Thesis, Helsinki Univerity, Helsinki, 2007.
[8]	M. de Vrese, et al., “Probiotic Bacteria Reduced Duration and Severity but not the Incidence of Common Cold Episodes in a Double Blind, Randomized, Controlled Trial,” Vaccine, Vol. 24, No. 44-46, 2006, pp. 6670-6674. http://dx.doi.org/10.1016/j.vaccine.2006.05.048
[9]	P. Winkler, M. de Vrese, C. Laue and J. Schrezenmeir, “Effect of a Dietary Supplement Containing Probiotic Bacteria plus Vitamins and Minerals on Common Cold Infections and Cellular Immune Parameters,” International Journal of Clinical Pharmacology and Therapeutics, Vol. 43, No. 7, 2005, pp. 318-326. http://dx.doi.org/10.5414/CPP43318
[10]	G. J. Leyer, S. Li, M. E. Mubasher, C. Reifer and A. C. Ouwehand, “Probiotic Effects on Cold and InfluenzaLike Symptom Incidence and Duration in Children,” Pediatrics, Vol. 124, No. 2, 2009, pp. e172-179. http://dx.doi.org/10.1542/peds.2008-2666
[11]	A. Berggren, I. Lazou Ahren, N. Larsson and G. Onning, “Randomised, Double-blind and Placebo-Controlled Study Using New Probiotic Lactobacilli for Strengthening the Body Immune Defence Against Viral Infections,” European Journal of Nutrition, Vol. 50, No. 3, 2011, pp. 203-210. http://dx.doi.org/10.1007/s00394-010-0127-6
[12]	H. Gill and J. Prasad, “Probiotics, Immunomodulation, and Health Benefits,” In: Z. Bosze, Ed., Bioactive Components of Milk, Springer, New York, 2008, pp. 423-454. http://dx.doi.org/10.1007/978-0-387-74087-4_17
[13]	F. Guarner, T. Requena and A. Marcos, “Consensus Statements from the Workshop Probiotics and Health: Scientific evidence,” Nutricion Hospitalaria, Vol. 25, No. 5, 2010, pp. 700-704.
[14]	M. de Vrese and J. Schrezenmeir, “Probiotics and NonIntestinal Infectious Conditions,” The British Journal of Nutrition, Vol. 88, Suppl. 1, 2002, pp. S59-S66.
[15]	R. L. Koretz, “Probiotics, Critical Illness, and Methodologic Bias,” Nutrition in Clinical Practice, Vol. 24, No. 1, 2009, pp. 45-49. http://dx.doi.org/10.1177/0884533608329296
[16]	M. de Vrese, et al., “Effect of Lactobacillus gasseri PA 16/8, Bifidobacterium longum SP 07/3, B. bifidum MF 20/5 on Common Cold Episodes: A Double Blind, Randomized, Controlled Trial,” Clinical Nutrition, Vol. 24, No. 4, 2005, pp. 481-491. http://dx.doi.org/10.1016/j.clnu.2005.02.006
[17]	K. Hatakka, et al., “Effect of Long Term Consumption of Probiotic Milk on Infections in Children Attending Day Care Centres: Double Blind, Randomised Trial,” BMJ, Vol. 322, No. 7298, 2001, p. 1327. http://dx.doi.org/10.1136/bmj.322.7298.1327
[18]	EFSA Panel on Dietetic Products Nutrition, “Guidance on the Scientific Requirements for Health Claims Related to Gut and Immune Function,” EFSA Journal, Vol. 9, No. 4, 2011, p. 1984.
[19]	B. Barrett, R. Brown, R. Voland, R. Maberry and R. Turner, “Relations among Questionnaire and Laboratory Measures of Rhinovirus Infection,” The European Respiratory Journal, Vol. 28, No. 2, 2006, pp. 358-363. http://dx.doi.org/10.1183/09031936.06.00002606