Kliničke studije

STUDIJA BROJ I – Klinička studija preparata Flobian kod Sindroma iritabilnog kolona

A controlled, double-blind, randomized study on the eficacyof Lactobacillus plantarum 299V in patients with irritablle bowel syndrome Krzysztof Niedzielina, Hubert Kordeckia and Bozena Birkenfeldb European Journal of Gastroenterology & Hepatology 2001, 13:1143±1147

  • Randomizovana, duplo-slepa, placebo kontrolisana studija
  • Cilj: pokazati efekat Lp299v kod različitih simptoma sindroma iritabilnog kolona

Procenjivani parametri

Samo-ocenjivanje: bol u stomaku, frekvenca i konzistencija stolice i nadutost

Trajanje studije: 4 nedelje

Dizajn studije: 40 pacijenata

Placebo grupa: 20 pacijenata – 5 muškaraca, 15 žena

Posmatrana grupa: 20 pacijenata – 3 muškarca,17 žena

  • Nijedan od pacijenata u posmatranoj grupi (Lp299v) nije imao bol u stomaku
  • 80% pacijenata u placebo grupi su i dalje patili od stomačnog bola
  • Nikakvi neželjeni efekti nisu uočeni u posmatranoj grupi (Lp299v)

FLOBIAN ima pozitivan efekat na bol u stomaku kod pacijenata sa Sindromom iritabilnog kolona

Grafikon1
% procenat pacijenata sa abdominalnim bolom

na kraju studije

 

  • 95% ispitanika u posmatranoj grupi (Lp299 v) je imalo poboljšanje svih simptoma iritabilnog kolona (delimično ili potpuno) – bol, opstipacija, dijareja i nadustost)
  • Samo 15% pacijenata u placebo grupi je pimetilo poboljšanje simptoma iritabilnog kolona – bol, opstipacija, dijareja i nadutost)
  • Statistički visoko značajna razlika p<0,0001

FLOBIAN ima pozitivan efekat na sve simptome Iritabilnog kolona (bol, opstipacija, dijareja i nadustost)

Grafikon2

STUDIJA BROJ II – Klinička studija preparata Flobian u terapiji Sindroma iritabilnog kolona

Alteration of Intestinal Microflora Is Associated With Reduction in Abdominal Bloating and Pain in Patients With Irritable Bowel Syndrome. Nobaek, M.D., Marie-Louise Johansson, Ph.D.,Molin, Ph.D., Siv Ahrne´, Ph.D., and Bengt Jeppsson, M.D., Ph.D., F.R.C.S. THE AMERICAN JOURNAL OF GASTROENTEROLOGY Vol.95, No. 5,2000© 2000 by Am. Coll. of Gastroenterology ISSN 00029270/00/$20.00

  • Randomizovana, duplo-slepa, placebo kontrolisana studija
  • Cilj: Pokazati efekat preparata FLOBIAN na produkciju gasa kod IBS pacijenata

Procenjivani parametri

Jednom nedeljno Visuelna Analogna Skala (VAS): sve funkcije GIT-a, defekacija, bol, i nadutost

Trajanje studije: 1 godina , Trajanje tretmana: 4 nedelje , Ponovna kontrola ispitanika: Nakon 12 meseci

Dizajn studije: 60 pacijenata (8 pacijenata isključeno)

Placebo grupa : 27 pacijenata,7 muškaraca i 20 žena

Posmatrana grupa : 25 pacijenata, 9 muškaraca i 16 žena

44% tretiranih pacijenata je pokazalo redukciju nadutosti.

Samo 18% pacijenata u placebo grupi je uočilo redukciju nadutosti.

Smanjena preterana produkcija gasa.

FLOBIAN ima pozitivan efekat na redukciju nadutosti kod IBS pacijenata

Grafikon3

Rezultati

  • Redukcija abdominalnog bola je trostruko brža i efikasnija nego kod pacijenata u placebo grupi Flobian ima pozitivan efekat na smanjenje bola kod pacijenata sa sindromom iritabilnog kolona
  • Značajno poboljšanje defekacije kod posmatranih pacijenata (p<0,01) u poređenju sa poboljšanjima bez statističkog značaja u placebo grupi (p=0,06)

Flobian ima pozitivni efekat na defekaciju kod pacijenata sa sindromom iritabilnog kolona

  • Kod pacijenata u posmatranoj grupi značajno su se popravile sve gastrointestinalne funkcije (nadutost, gasovi, abdominalni bol, konstipacija ili diareja)

Flobian ima pozitivan efekat na sve gastrointestinalne funkcije pacijenata sa sindromom iritabilnog kolona

FLOBIAN: NAUČNO DOKAZANA EFIKASNOST

Kod pacijenata sa sindromom iritabilnog kolona:

  • Redukcija abdominalnog bola
  • Popravljanje svih gastrointestinalnih funkcija
  • Smanjenje nadutosti
  • Popravljanje funkcije defekacije

Lista studija:

Niedzielin, K., Kordecki, H and Birkenfeld, B. 2001. A controlled double-blind, randomized study on the efficacy of Lactobacillus plantarum 299v in patients with irritable bowel syndrome. European Journal of Gastroenterology andl Hepatology 13:1-5

Nobaek, S., Johansson, M.-L., Molin, G., Ahrné, S. and Jeppsson, B. 2000. Alteration of intestinal microflora is associated with reduction in abdominal blaoting and pain in patients with irritable bowel syndrome (IBS). American Journal of Gastroenterology 95: 1231-1238.

P. Samart, J. Venkatraman, P. Ducrotté . Evaluation of Lactobacillus Plantarum 299v Efficacy in IBS: Results of a Randomized Placebo-Controlled Trial in 200 Patients. T2030- Poster Session: Prebiotics and probiotics in the intestine: activities and function. Digestive Disease Week 2010, New Orleans.

Bengmark, S. and Gianotti, L. 1996. Nutritional support to prevent and treat multiple organ failure. World Journal of Surgery 20: 474-481.

Molin, G. 2001. Probiotics in food not containing milk or milk constituents, with special reference to Lactobacillus plantarum 299v. American Journal of Clinical Nutrition 73: 380S-385S

Molin, G., Jeppsson, B., Johansson, M.-L., Ahrné, S., Nobaek, S., Ståhl, M. and Bengmark, S. 1993. Numerical taxonomy of Lactobacillus spp. associated with healthy and diseased mucosa of the human intestines. Journal of Applied Bacteriology 74: 314-323.

Johansson, M.-L., Quednau, M., Molin, G. and Ahrné, S. 1995. Randomly Amplified Polymorphic DNA (RAPD) for rapid typing of Lactobacillus plantarum strains. Letters in Applied Microbiology 21: 155-159.

Ahrné, S., Nobaek, S., Jeppsson, B., Adlerberth, I., Wold, A.E and Molin, G. 1998. The normal Lactobacillus flora of healthy human rectal and oral mucosa. Journal of Applied Microbiology 85: 88-94.

Kasravi, F.B., Adawi, D., Molin, G., Bengmark, S. and Jeppsson, B. 1996. Effect of oral supplementation of lactobacilli on bacterial translocation in acute liver injury induced by D-galactoseamine. Journal of Hepatology 26: 417-424.

Mao, Y., Nobaek, S., Kasravi, B., Adawi, D., Stenram, U., Molin, G. and Jeppsson, B. 1996. The effects of Lactobacillus strains and oat fiber on Methotrexate-induced enterocolitis in rats. Gastroenterology 111: 334-344.

Adawi D, Kasravi FB, Molin G, Jeppsson B. 1997. Effect of Lactobacillus supplementation with and without arginine on liver damage and bacterial translocation in an acute liver injury model in the rat. Hepatology. 1997 Mar;25(3):642-7. PMID: 9049212 [PubMed – indexed for MEDLINE]

Adawi, D., Molin, G., Jeppson, B. 1999. Inhibition of Nitric Oxide Production and the Effects of Arginine and Lactobacillus Administration in an Acute Liver Injury Model. Annals of Surgery. Vol. 228, No. 6, 748-755.

Herias, M.V., Hessle, C., Midtvedt, T., Hanson, L.Å. and Wold A.E. 1999. Immunomodulatory effects of Lactobacillus plantarum colonizing the intestine of gnotobiotic rats. Clinical Experimental Immunology 116: 283-290.

Mangiante, G., Colucci, G., Canepari, P., Bassi, C., Nicoli, N., Casaril, A., Marinello, P., Signoretto, C. and Bengmark, S. 2001. Lactobacillus plantarum reduces infection of pancreatic necrosis in experimental acute pancreatitis. Digestive Surgery 18: 47-50

Mangell, P., Nejdfors, P., Wang, M., Ahrné S., Weström B., Thorlacius, H. and Jeppsson, B. Lactobacillus plantarum 299v Inhibits Esherichia coli– Induced intestinal Permeability. Digestive Diseases and Sciences 2002; 47: 511-516

Schultz, M., Veltkamp, C., Dieleman, L. A., Grenther, W. B., Wyrick, P. B., Tonkonogy, S. L. and Sartor, R. B. 2002 Lactobacillus plantarum 299v in the treatment and prevention of spontaneous colitis in interleukin-10-deficient mice. Inflammatory Bowel Disease 8(2): 71-80.

Osman N, Adawi D, Ahrne S, Jeppsson B, Molin G. 2004 Modulation of the effect of dextran sulfate sodium-induced acute colitis by the administration of different probiotic strains of Lactobacillus and Bifidobacterium. Dig Dis Sci Feb;49(2):320-7

Osman N, Adawi D, Molin G, Ahrne S, Berggren A, Jeppsson B. 2006 Bifidobacterium infantis strains with and without a combination of oligofructose and inulin (OFI) attenuate inflammation in DSS-induced colitis inrats. BMC Gastroenterol. 28;6:31.

Mangell P, Lennernas P, Wang M, Olsson C, Ahrne S, Molin G, Thorlacius H, Jeppsson B. 2006 Adhesive capability of Lactobacillus plantarum 299v is important for preventing bacterial translocation in endotoxemic rats. APMIS. Sep;114(9):611-8

Hakansson A, Stene C, Mihaescu A, Molin G, Ahrne S, Thorlacius H, Jeppsson B. 2006 Rose hip and Lactobacillus plantarum DSM 9843 reduce ischemia/reperfusion injury in the mouse colon. Nov;51(11):2094-101. Epub 2006 Sep 29

Nishikawara F, Katsumura S, Ando A, Tamaki Y, Nakamura Y, Sato K, Nomura Y, Hanada N. 2006 Correlation of cariogenic bacteria and dental caries in adults. J. Oral Sci. Vol.48, No.4, 245-251.

Fåk F, Ahrné S, Linderoth A, Molin G, Jeppsson B, Weström B. 2007. Agerelated Effects of the Probiotic Bacterium Lactobacillus plantarum 299v on Gastrointestinal Function in Suckling Rats. Dig Dis Sci. 7; [Epub ahead of print]

Johansson, M.-L., Molin; G., Jeppsson, B., Nobaek, S., Ahrné, S. and Bengmark, S. 1993. Administration of different Lactobacillus strains in fermented oatmeal soup: in vivo colonization of human intestinal mucosa and effect on the indigenous flora. Applied and Environmental Microbiology 59: 15-20.

Vanderhoof, J. A., Young, J. R., Murray, N. and Kaufman, S. S. 1998. Treatment strategies for small bowel bacterial overgrowth in short bowel syndrome. Journal of Pediatric Gastroenterology and Nutrition, 27: 155-160.

Johansson, M.-L., Nobaek, S., Berggren, A., Jeppsson, B., Ahrné, S., Nyman, M., Björck, I. and Molin, G. 1998. Survival of Lactobacillus plantarum DSM 9843 (299v), and effect on the short-chain fatty acid content of faeces after ingestion of a rose-hip drink with fermented oats. International Journal of Food Microbiology 42: 29-38.

Kingamkono, R., Sjögren, E. and Svanberg, U. 1999. Enteropathogenic bacteria in faecal swabs of young children fed on lactic-acid fermented cereal gruels. Epidemiology and Infection 122: 23-32

Stjernquist-Desantik, A., Warfving, H. and Johansson, M-L. 2000. Persistence of Lactobacillus plantarum DSM 9843 on Human Tonsillar Surface after Oral Administration in Fermented Oatmeal Gruel. Acta Otolaryngol, Suppl 543: 215-219

Naruszewicz, M., Johansson, M-L., Zapolska-Downar, D. and Bukowska, H. 2002. Effect of Lactobacillus plantarum 299v on cardiovascular risk factors in smokers. American Journal of Clinical Nutrition –76: 1249-55.

Önning, G, Berggren, A, Drevelius, M., Jeppsson, B., Lindberg, A-M and Johansson Hagslätt, M-L. 2003. Influence of a drink containing different antioxidants and Lactobacillus plantarum 299v on plasma total antioxidant capacity, selenium status and faecal microbial flora. International Journal of Food Sciences and Nutrition, Vol.54, No.4:281-289

Wullt, M., Johansson

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Hagslätt, M.-L. & Odenholt, I. (2003) Lactobacillus plantarum 299v for the treatment of recurrent clostridium difficile-associated diarrhoea: A double-blind, placebo-controlled trial. Scandinavian Journal of Infectious Diseases 35: 365-367

Goossens, D., Jonkers, D., Russel, M., Stobberingh E., Van Der Bogaard, A. & Stockbrugger, R. (2003) The effect of Lactobacillus plantarum 299v on the bacterial competition and metabolic activity in faeces of healthy volunteers: a placebo controlled study on the onset and duration of effects. Aliment Pharmacol Ther 2003; 18: 495-505

Klarin B, Johansson ML, Molin G, Larsson A, Jeppsson B. 2005 Adhesion of the probiotic bacterium Lactobacillus plantarum 299v onto the gut mucosa in critically ill patients: a randomised open trial. Crit Care. Jun;9(3):R285-93. Epub 2005 Apr 28

Goossens D, Jonkers D, Russel M, Thijs A, van den Bogaard A, Stobberingh E, Stockbrugger R. 2005 Survival of the probiotic, L. plantarum 299v and its effects on the faecal bacterial flora, with and without gastric acid inhibition. Dig Liver Dis. Jan;37(1):44-50

Bering S, Suchdev S, Sjoltov L, Berggren A, Tetens I, Bukhave K. 2006 A lactic acid-fermented oat gruel increases non-haem iron absorption from a phytate-rich meal in healthy women of childbearing age. Br J Nutr. Jul;96(1):80-5

Wullt M, Johansson Hagslatt ML, Odenholt I, Berggren A. Lactobacillus plantarum 299v Enhances the Concentrations of Fecal Short-Chain Fatty Acids in Patients with Recurrent Clostridium difficile-Associated Diarrhea. Dig Dis Sci. 2007 Apr 10; [Epub ahead of print]

Adlerberth, I., Ahrné, S., Johansson, M-L., Molin, G. and Wold, A.E. 1996. A mannose-specific adherence mechanism in Lactobacillus plantarum conferring binding to the human colonic cell line HT-29. Applied and Environmental Microbiology 62: 2244-2251.

Mack, D. R., Michail, S., Wei, S., McDougall, L. and Hollingsworth, M. 1999. Probiotics inhibit enteropathogenic E. coli adherence in vitro by inducing intestinal mucin gene expression. American Journal of Physiology, 276: G941-G950.

Jacobsen, C. N., Nielsen, R., Hayford, A. E., Moeller, P. L., Michaelsen, K. F., Paerregaard, A., Sandström, B., Tvede, M. and Jakobsen, M. 1999. Screening of probiotic activities of forty-seven strains of Lactobacillus spp. by in vitro techniques and evaluation of the colonization ability of five selected strains in humans. Applied and Environmental Microbiology 65: 4949-4956.

McCracken, V.J, Chun, T., Baldeon, M.E., Ahrné, S., Mohlin, G., Mackie, R.I. & Gaskins, H.R. (2002) TNF-α sensitizes HT-29 colonic epithelial cells to intestinal lactobacilli. Experimental Biology and Medicine 227 (8): 665-670

Cunningham-Rundles, S., Ahrné, S., Abuav-Nussbaum, R. and Dnistrian, A. (2002) Development of Immunocompetence: Role of Micronutrients and Microorganisms. Nutrition Reviews, Vol. 60, No. 5 : 68-72

Mack, D. R., Ahrne, S., Hyde, L., Wei, S. & Hollingsworth M.A. (2003) Extracellular MUC3 mucin secretion follows adherence of Lactobacillus strains to intestinal epithelial cells in vitro. Gut, Vol. 52, No. 6: 827-833

Hutt P, Shchepetova J, Loivukene K, Kullisaar T, Mikelsaar M. 2006 Antagonistic activity of probiotic lactobacilli and bifidobacteria against enteroand uropathogens. J Appl Microbiol. Jun;100(6):1324-32