Table 5. Effect of Bio L6® probiotic consumption on feces consistency.
Table 6. Adverse events during consumption of Bio L6® probiotic.
3.3. Bacteriological Study
We observed the presence of at least 3 different types of LAB that were present in BIO L6 and absent from volunteers’ stool before treatment; these were present in stools during treatment and two days after it in all subjects, meaning that the LAB present in the probiotic carried out intestinal colonization. We also observed a decrease in coliform bacteria (data not shown).
Almost a century ago, Élie Metchnikoff proposed the revolutionary idea of consuming viable bacteria to promote health . The field known as “probiotics” has made dramatic progress since then, particularly during the past two decades. It is known that colonization begins at birth and is followed by the progressive assembly of a complex and dynamic microbial society regulated by elaborate and combinatorial microbial-microbial and hostmicrobial interactions . This microflora has a wide range of functions in the host: it directs the assembly of the gut-associated lymphoid tissue; “educates” the immune system; modulates proliferation and differentiation of its epithelial lineages; regulates angiogenesis; modifies the activity of the enteric nervous system, and plays a key role in extracting and processing nutrients consumed in the diet [4,20-23]. The fragile composition of gut microflora can be affected by various factors such as age, diet, environment, stress and medication. Changes in microflora will in turn affect the physiology and pathophysiology of GIT, particularly in the human intestine . The aim of this prospective study with historical control was to evaluate the efficacy and safety of a probiotic mixture in healthy volunteers with evacuation disorders, a very frequent problem in healthy populations of any age and one with important economic and social implications.
The motility of the GIT is important for absorption, transport, and clearance. Absorption is promoted by slow transit because of prolonged contact time, whereas clearance is aided by rapid transit . The effect of gut microflora on intestinal motility takes place through several known mechanisms, including the release of substances that stimulate the enteric nervous system and primary afferent neurons. This process occurs in a context of infection and inflammation as well as in the healthy gut . The present study demonstrates that Bio L6® increased the number of evacuations in treated subjects and that this effect continued ten days after the end of treatment. Previous studies have shown that gut transit is slow in the absence of intestinal microflora . It has also been reported that intestinal microflora is involved in the development and maintenance of gut sensory and motor functions through the release of bacterial substances, fermentation products and intestinal neuroendocrine factors, as well as through a close link with the gastrointestinal immune system . The end products of bacterial metabolism affect gut motor function via neuromodulation and have direct effects on intestinal smooth muscle contractility . The cyclic recurrence and distal propagation of interdigestive migrating motor complexes (MMCs) is also linked to intestinal flora. It has been shown that germ-free animals have delayed gastric emptying and slowed intestinal transit compared with conventionally raised counterparts. It has also been demonstrated that the introduction of gut microflora into germfree rats stimulated interdigestive intestinal motility and accelerated intestinal transit [30,31]. We demonstrated that subjects receiving Bio L6® experienced increased ease expulsion during and after 10 days of treatment, which indicates that Bio L6® accelerated intestinal transit in these subjects.
Constipation means different things to different individuals; some think of it as stool frequency, others relate it to stool form and consistency, difficulties defecating or a sense of incomplete evacuation . A number of studies have demonstrated probiotics’ ability to shorten colonic transit and soften the feces in healthy subjects, the elderly, and people with irritable bowel syndrome (IBS) [33-35]. Our research agrees with those studies: subjects showed an important softening of feces during and after Bio L6® treatment.
The safety of the microorganisms that have been traditionally used in probiotics has been confirmed through a long period of experience. Side effects are rare, but the most common is gastrointestinal distress. When large doses of probiotics are consumed, they adjust the floral balance of the digestive tract and can result in gas or abdominal discomfort. These side effects are usually temporary and, ultimately, benign [36,37]. In present study, reported side effects encompassed flatulence, abdominal pain and diarrhea.
This pilot study showed that a probiotic mixture containing eleven strains of LAB (Bio L6®) was effective, safe and beneficial in subjects suffering from evacuation disorders. Some of the positive effects continued for 10 days after the suspension of the active formulations. This was due to an active reproduction of the strains in the intestinal lumen, as demonstrated by the microbiological studies.
We would like to thank the Arkansas Biosciences Institute Supported Research project entitled “Development of a Lactobacillus Probiotic for Reducing Cancer-Associated Immunosuppressive and Antibiotic-Induced Diarrhea”.
- P. B. Eckburg, E. M. Bik, C. N. Bernstein, E. Purdom, L. Dethlefsen, M. Sargent, S. R. Gill and K. E. Nelson, “Diversity of the Human Intestinal Microbial Flora,” Science, Vol. 308, No. 5728, 2005, pp. 1635-1638. doi:10.1126/science.1110591
- Å. Sullivan and C. E. Nord, “Probiotics and Gastrointestinal Diseases,” Journal of Internal Medicine, Vol. 257, No. 1, 2005, pp. 78-92. doi:10.1111/j.1365-2796.2004.01410.x
- A. Suau, R. Bonnet, M. Sutren, J. J. Godon, G. R. Gibson, M. D. Collins and J. Doré, “Direct Analysis of Genes Encoding 16 s Rrna from Complex Communities Reveals Many Novel Molecular Species within the Human Gut,” Applied Environmental Microbiology, Vol. 65, No. 11, 1999, pp. 4799-4807.
- E. F. Verdu and S. M. Collins, “Microbial-Gut Interactions in Health and Disease. Irritable Bowel Syndrome,” Best Practice in Research of Clinical Gastroenterology, Vol. 18, No. 2, 2004, pp. 315-321. doi:10.1016/j.bpg.2003.11.003
- R. A. Rastall, “Bacteria in the Gut: Friends and Foes and How to Alter the Balance,” Journal of Nutrition, Vol. 134, No. 8, 2004, pp. 2022S-2026S.
- E. F. Verdú, P. Bercík, G. E. Bergonzelli, X. X. Huang, P. Blennerhasset, F. Rochat, M. Fiaux, R. Mansourian, I. Corthésy-Theulaz and S. M. Collins, “Lactobacillus Paracasei Normalizes Muscle Hypercontractility in a Murine Model of Postinfective Gut Dysfunction,” Gastroenterology, Vol. 127, No. 3, 2004, pp. 826-837. doi:10.1053/j.gastro.2004.06.007
- V. Gupta and R. Garg, “Probiotics,” Indian Journal of Medical Microbiology, Vol. 27, No. 3, 2009, pp. 202-209. doi:10.4103/0255-0857.53201
- S. Santosa, E. Farnworth and P. J. Jones, “Probiotics and Their Potential Health Claims,” Nutrition, Vol. 64, No 6, 2006, pp. 265-274.
- M. Del Piano, L. Morelli, G. P. Strozzi, S. Allesina, M. Barba, F. Deidda, P. Lorenzini, M. Ballaré, F. Montino, M. Orsello, M. Sartori, E. Garello, S. Carmagnola, M. Pagliarulo and L. Capurso, “Probiotics: From Research to Consumer,” Digestive Liver Disease, Vol. 38, No. 2, 2006, pp. S248-S255. doi:10.1016/S1590-8658(07)60004-8
- Y. Benno, F. He, M. Hosoda and H. Hashimoto, “Effect of Lactobacillus GG Yoghurt on Human Intestinal Microecology in Japanese Subjects,” Nutrition Today, Vol. 31, No. 1, 1996, pp. 9S-11S. doi:10.1097/00017285-199611001-00004
- M. A. López Cara, P. J. Tárraga López, M. Cerdán Oliver, J. M. Ocaña López, A. Celada Rodríguez, J. Solera Albero and M. A. Palomino Medina, “Constipation in the Population over 50 Years of Age in Albacete Province,” Revista Española de Enfermedades Digestivas, Vol. 98, No. 6, 2006, pp. 449-459.
- M. E. Sanders, “Effect of Consumption of Lactic Cultures on Human Health,” Adverse Food Nutrition, Vol. 37, 1993, pp. 67-130. doi:10.1016/S1043-4526(08)60116-3
- R. Spiller, “Review Article: Probiotics and Prebiotics in Irritable Bowel,” Alimentary Pharmacology & Therapeutics, Vol. 28, No. 4, 2008, pp. 385-396. doi:10.1111/j.1365-2036.2008.03750.x
- M. Pimentel and C. Chang, “Inflammation and Microflora,” Gastroenterology Clinical of North American, Vol. 40, No. 1, 2011, pp. 69-85. doi:10.1016/j.gtc.2010.12.010
- M. Othman, R. Agüero and H. C. Lin, “Alterations in Intestinal Microbial Flora and Human Disease,” Current Opinion in Gastroenterology, Vol. 24, No. 1, 2008, pp. 11-16. doi:10.1097/MOG.0b013e3282f2b0d7
- W. H. Ling, O. Hanninen and H. Mykkanen, “Colonization and Fecal Enzyme Activities after Oral Lactobacilus GG Administration in Elderly Nursing Home Residents,” Annual Nutrition and Metabolism, Vol. 36, No. 3, 1992, pp. 162-166. doi:10.1159/000177712
- World Medical Association Declaration of Helsinki, “Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects,” Edinburgh, WMA, 2000. http://www.wma.net
- European Agency for the Evaluation of Medicinal Products, International Conference on Harmonization-World Health Organization, “Guideline for Good Clinical Practice,” ICH Topic E6 Geneva, 2002. http://www.emea.eu.int
- I. Metchnikoff, “Prolongation of Life: Optimistic Studies,” Putnam & Sons, New York, 1908.
- J. H. Cummings, J. L. Rombeau and T. Sakata, “Physiological and Clinical Aspects of Short-Chain Fatty Acids,” Cambridge University Press, Cambridge, 1995.
- H. Mahrous, “Probiotics Bacteria from Egyptian Infants Cause Cholesterol Removal in Media and Survive in Yoghurt,” Food and Nutrition Sciences, Vol. 2, No. 2, 2011, pp. 150-155. doi:10.4236/fns.2011.22021
- C. F. Favier, E. E. Vaughan, M. W. De Vos and A. D. Akkermans, “Molecular Monitoring of Succession of Bacterial Communities in Human Neonates,” Applied of Environmental Microbiology, Vol. 68, No. 1, 2002, pp. 219- 226. doi:10.1128/AEM.68.1.219-226.2002
- J. J. Cebra, “Influences of Microbiota on Intestinal Immune System Development,” American Journal Clinical Nutrition, Vol. 69, No. 5, 1999, pp. 1046S-1051S.
- S. L. Gorbach “Perturbation of Intestinal Microflora,” Veterinary and Human Toxicology, Vol. 35, No. 1, 1993, pp. 15-23.
- E. M. Wright, M. G. Martin and E. Turk, “Intestinal Absorption in Health and Disease—Sugars,” Best Practice Research of Clinical Gastroenterology, Vol. 17, No. 6, 2003, p. 943. doi:10.1016/S1521-6918(03)00107-0
- G. D. Abrams and J. E. Bishop, “Effect of the Normal Microbial Flora on Gastrointestinal Motility,” Proceeding Society of Experimental Biological Medicine, Vol. 126, No. 1, 1967, pp. 301-304.
- L. V. Hooper, T. Midtvedt and J. I. Gordon, “How HostMicrobial Interactions Shape the Nutrient Environment of the Mammalian Intestine,” Annual Review of Nutrition, Vol. 22, 2002, pp. 283-307. doi:10.1146/annurev.nutr.22.011602.092259
- V. Lesniewska, I. Rowland, H. N. Laerke, G. Grant and P. J. Naughton, “Relationship between Dietary-Induced Changes in Intestinal Commensal Microflora and Duodenojejunal Myoelectric Activity Monitored by Radiotelemetry in the Rat in Vivo,” Experimental Physiology, Vol. 91, No. 1, 2006, pp. 229-237. doi:10.1113/expphysiol.2005.031708
- C. Cherbut, A. C. Aube, H. M. Blottiere and J. P. Galmiche, “Effects of Short Chain Fatty Acids on Gastrointestinal Motility,” Scandinavian Journal Gastroenterology, Vol. 222, 1997, pp. 58-61.
- E. Husebye, P. M. Hellström, F. Sundler, J. Chen and T. Midtvedt, “Influence of Microbial Species on Small Intestinal Myoelectric Activity and Transit in Germ-Free Rats,” American Journal of Physiology and Gastrointestinal Liver Physiology, Vol. 280, No. 3, 2001, pp. G368- G380.
- E. Husebye, P. M. Hellstrom and T. Midtvedt, “Introduction of Conventional Microbial Flora to Germfree Rats Increases the Frequency of Migrating Myoelectric Complexes,” Journal Gastrointestinal Motility, Vol. 4, No. 1, 1992, pp. 39-45. doi:10.1111/j.1365-2982.1992.tb00077.x
- M. M. Tabbers, I. De Milliano, M. G. Roseboom and M. A. Benninga, “Is Bifidobacteriumbreve Effective in the Treatment of Childhood Constipation? Results from a Pilot Study,” Nutrition Journal, Vol. 10, No. 19, 2011, pp. 1-5.
- Y. Vandenplas and M. Benninga, “Probiotics and Functional Gastrointestinal Disorders in Children,” Journal of Pediatric Gastroenterology Nutrition, Vol. 48, Suppl. 2, 2009, pp. S107-S109. doi:10.1097/MPG.0b013e3181a1603a
- A. Chmielewska and H. Szajewska, “Systematic Review of Randomised Controlled Trials: Probiotics for Functional Constipation,” World Journal of Gastroenterology, Vol. 16, No. 1, 2010, pp. 69-75.
- H. Zaharoni, E. Rimon, H. Vardi, M. Friger, A. Bolotin and D. R. Shahar, “Probiotics Improve Bowel Movements in Hospitalized Elderly Patients-The PROAGE Study,” Journal of Nutrition and Health Aging, Vol. 15, No. 3, 2011, pp. 215-220. doi:10.1007/s12603-010-0323-3
- N. Ishibashi and S. Yamazaki, “Probiotics and Safety,” American Journal of Clinical Nutrition, Vol. 73, No. 2, 2001, pp. 465S-470S.
- Saxelin, K. Collins, G. Mogensen, S. Birkeland and T. Mattila-Sandholm, “Demonstration of Safety of Probiotics: A Review,” International Journal of Food Microbiology, Vol. 44, No. 1-2, 1998, pp. 93-106. doi:10.1016/S0168-1605(98)00128-7