EcN

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ecn escherichia coli niessle 1914 | cadigroup.eu
Lyophilized viable bacteria of Escherichia Coli strain Nissle 1917.
For maintenance of remission of Ulcerative Colitis.

20 gastro-resistant hard capsules

DOSAGE, MODE AND DURATION OF ADMINISTRATION

Adults and teenagers: standard dose: from day1 to day4, 1 capsule of EcN daily, then 2 capsules EcN daily.
The standard dose should be taken with a meal, if possible with breakfast, and an appropriate amount of fluid. Avoid to chew the capsules.
In order to avoid initial flatulence the dose may be slowly increased. With onset of flatulence or with a daily dose higher than the standard dose, the daily dose may be split and administrated with meals spread evenly throughout the day.
In case of Ulcerative Colitis, experience from controlled trials exist for a duration of administration of 12 months. For relapse prevention in ulcerative colitis, EcN should be taken continuously.

INDICAZIONI

  1. 1. Ulcerative Colitis in phase of remission
  2. In subjects with hyper-sensitivity or intolerance to Mesalazine
  3. In association with the Mesalazine, to reduce the dosage and enhance its action
  4. in ulcerative proctitis
  5. in post infectious colitis to IBS

CONTROINDICATIONS AND ADVERSE DRUG EFFECTS

Hypersensitivity against any ingredient of the preparation.
Frequently, initial flatulence occurs. Changes in stool consistency or frequency, abdominal pain, borborygm, meteorism, nausea, vomiting, cases of skin efflorescences, erythema, or skin flaking were observed very rarely.

STORAGE PRECAUTIONS

EcN should be stored under refrigeration (2-8°C)! A short interruption of refrigeration does not do any harm to the product. In case of prolonged storage at room temperature or even higher temperatures, bacteria will lose their viability but not their safety profile.

COMBINATION WITH ANTIBIOTICS

If treatment with antibiotics is necessary, these can also be combined with EcN. If the antibiotic is directed against Gram-negative bacteria, however, loss of efficacy of EcN is to be expected.
With antibiotics that are mainly directed against Gram-positive bacteria (such as Clindamycin, Erythromycin, Metronidazole, Penicillin G, Rifampin, Vancomycin, Cafsulodin), no loss of efficacy of EcN occurs.

BIBLIOGRAPHY

Studi clinici ESCHERICHIA COLI NISSLE 1917:
– Bruckschen E et al. Chronische Obstipation. Vergleich von mikrobiologischer Therapie und Lactulose. MMW 1994; 16.241-245
– ‘Cukrowska B et al. Specific proliferative and antibody responses of premature infants to intestinal colonization with nonpathogenic probiotic E coli strain Nissle 1917. Scand J lmmunol 2002; 55: 204-209.
– Fric P et al. The effect of non-pathogenic Escherichia coli in symptomatic uncomplicated diverticular disease of the colon. Eur J Gastroenterol Heoatol 2003. 15:313-5.
– Goerg KJ et al. A new approach in pseudomembranous colitis: probiotic Escherichia coli Nissle 1917 after intestinal lavage. Eur J Gastroenterol Hepatol 2008; 20(2): 155-156.
– HenkerJ et al. Probiotic Escherichia coli Nissle 1917 (EcN) for successful remission maintenance of ulcerative Colitis in children and adolescents: an open-label pilot study Z Gastroenterol 2008; 46:874-875.
– Henker J et al. The Wobiolic Escherichia coli strain Nissle 1917 (EcN) stops acute diarrhea in infants and toddlers. Eur J Pediatr 2007; 1 66(4): 31 1 -31 L
– Henker J et al. .Probiotic Escherichia coli Nissle 1917 versus placebo for treating diarrhea of greater than 4 days duration in infants and toddlers. Pediatr Infect Dis J 2008i 27(6):494-499.
– Henker J et al. Successful treatment of gut-caused halitosis with a suspension of living ‘non-pathogenic’ Escherichia coli bacteria-a case
report.EurJPediatr200l;160:592-594.
– Keller J et al. Reizdarm-Patienten mit Meteorismus als dominantem Symptom profitieren von einer Therapie mit E. coll Nissle 1917 – Ergebnisse einer Pilotstudie. Z Gastroenterol 2010;48:959.
– Krammer H et al. Probiotische Arzneimitteltherapie mit E. coli Stamm Nissle 1917 (EcN): Ergebnisse einer prospektiven Datenerhebung mit 3807 Patienten. Z Gastroenterol 2006;44: 651 -656.
– Kruis W et al. Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine. Gut 2004;53: 16’17-1623.
– Kruis W et al. Doublé-blind comparison of an oral Escherichia coli preparation and mesalazine in maintaining remission of ulcerative colitis. Alìment Pharmacol Ther 1997; 11: 853-858.
– Kruis W et al. A double-blind placebo-controlled trial to study therapeutic effects of probiotic Escherichia coli Nissle 1917 in subgroups of patients with irritable bowel syndrome. Int JColorectal Dis 201 2; 27(4): 467-474.
– Kuzela L et al. Induction and maintenance of remission with nonoathoqenic Escherichia coli in patients with pouchitis. Am J Gastroenterol 2001 ; 96: 321 8-321 9.
– Lata J et al. The effect of probiotics on gut flora, level of endotoxin and Child-Pugh score in cirrhotic patients: results of a double-blind randomized study. Eur J Gastroenterol Hepatol 2007; 19: 1111-1113.
– Lodinové-Zédníkové R et al. Effect of preventive administration of a nonpathogenic Escherichia coli strain on the colonization of the intestine with microbial pathogens in newborn infants.Biol Neonate 1997; 71:224-232.
– Lodinové-zédníkové R et al. Local and serum antibody response in fullterm and premature infants after artificial colonization of the intestine with E coli strain Nissle 1917 (Mutaflor). Pediatr Allergy lmmunol 1992; 3: 43-48.
– Malchow HA. Crohn’s Disease and E.coli. J CIin Gastroenterol 1997; 25: 653-658.
– Malchow H et al. Colonization of adults_by an apathogenic E coli strain administered after gut decontamination. Gastroenterology 1995; Suppl. ‘108: 869.
– Matthes H et al. Clinical trial: probiotic treatment of acute distal ulcerative colitis with rectally administered Escherichia coli Nissle 1917 (EcN). BMC Complement Altern Med 2010;10:13.
– Mollenbrink M et al. Behandlung der chronischen Obstipation mit physiologischen Escherichia-coli-Baktetien. Med Klin 1 994 ; 89 : 587-593.
– Plassmann D, Schulte-Witte H. Treatment of irritable bowel svndrome with Escherichia coli strain Nissle 1917 (EcN): a retrospective survey. Med Klin (Múnich) 2007; 102(11):888-892.
– Rembacken BJ et al. Non-pathogenlc Escherichia coli versus mesalazine for the treatment of ulcerative colitis: a randomised trial. Lancet 1999; 354: 635-639
– Schròder H. Entwicklung der aeroben Darmflora bei Neugeborenen nach Kolonisierung mit dem E.coli-Stamm Nissle 1917. Der Kinderarzt 1992;23(10): 1619-25.
– Tromm A el al. The probiotic E coli strain Nissle 1917 for the treatment of collagenous colitis: First results of an open-labelled trial Z. Gastroenterol 2004; 365-369.
– Wurzel R. Prophylaxe der polymorphen Lichtdermatose. Akt Dermatol 1 999; 25: 329-333.

Ulteriori evidenze e studi preclinici:

– Altenhoefer A et al. The Probiotic Escherichia coli strain Nissle 1917 interferes with invasion of human intestinal epithelial cells by different enteroinvasive bacterial pathogens. FEMS lmmunol lVled Microbiol 2004; 40:223-229.
– Bar F et al. Cell-free supernatants of Escherichia coli Nissle 1917 modulate human colonic motility: evidence from an in vitro organ bath study. Neurogastroenterol Motil 2009;21:559-e17.
– Bischoff SC. (Hrsg). Probiotika, Pràbiotika und Synbiotika. ceorg Thieme Verlag, Stuttgart, lsBN 978-3-1 3-1 44891 -0, 2009.
– Blum-Oehler G et al. Development of strain-specifìc PCR reactions for the detection of the probiotic Escherichia coli strain Nissle 1917.in fecal samples. Res Microbiol 2003; 154: 59-66.
– Blum G et al. Properties of Escherichia coli strains of serotype O 6. Infection 1995; 23:234-236.
– Boudeau J et al. Inhibitory effect of probiotic Escherichia coli strain Nissle 1917 on adhesion to and invasion of intestinal epithelial cells by adherent-invasive E. coli strains isolated from patients with Crohn’s disease. Aliment Pharmacol Ther 2003; 1 8: 45-56.
– Cichon C et al. DNA-Microanay-based comparison of cellular responses in polarized T84 epithelial cells triggered by probiotics; E. coli Nissle 1917 (EcN) and Lactobacillus acidophilus PZ1 041. Gastroenterology 2004; 1 26[4]: A-578.
– Grabig A et al. Escherichia coli strain Nissle 1917 ameliorates experimental colitis via Tolflike receptor-2 and Toll-like receptor-4 dependent pathways. Infect lmmun 2006; 74:4075-4082.
– Grozdanov L et al. Analysis of the Genome Structure of the Nonpathogenic Probiotic Escherichia coli Strain Nissle 1 91 7 J Bacteriol. 2004; 1 86: 5432-5441.
– Grozdanov L et al. A single nucleotide exchange in the wzy gene is responsible for the semirough O6 lipopolysaccharide phenotype and serum sensitivity of Escherichia coli strain Nissle 1917. J Bacteriol 2002′, 1 84: 591 2-5925.
– Guzy C et al. The probiotic Escherichia coli strain Nissle 1 91 7 induces gammadelta T cell apoptosis via caspase- and Fast-dependent pathways. lnt lmmunol 2008;20:829-840.
– Hockertz S. Steigerung der kórpereigenen Abwehr gegen Bakterien- und Pilzinfektionen bei Màusen nach Vorbehandlung mit dem apathogerien Escherichia coli-,Stamm Nissle 1917. Arzneim.-Forsch./Drug Res. 1 997;47(l)(6): 793-796.
– Hoogkamp-Korstanje JA et al. Composition and ecology of the human intestinal flora. Antonie Van Leeuwenhoek 1979; 45(1); 35-40.
– Kamada N et al. Nonpathogenlc Escherichia coli Strain Nissle1917 Prevents Murine Acute and Chronic Colitis. Inflammatory Bowel Diseases 2005; 11(5):455-463.
– Kamada N et al. Non-pathogenlc Eschetichia coli strain Nissle 1917 inhibits signal transduction in intestinal epithelial cells. Infect lmmun 2008;76:214-220.
– Layer P 53-Leitlinie Reizdarmsyndrom: Definition, Pathophysiologie, Diagnostik und Therapie.Z Gastroenterol 2011: 49:237-293.
– Leatham MP et al. Precolonized human commensal Escherichia coli strains serve as a barrier to E coli O157:H7 growth in the streptomycin-treated mouse intestine. Infect lmmun 2009i 77:2876-2886.
– Liebregts T et al. Effect of E coli Nissle 1917 on post-inflammatory visceral sensory function in a rat model. Neurogastroenterol Motil 2005, 17, 410414.
– Lorenz A, Schulze J. Establishment of E coli Nissle 1 917 and its interaction with Candida albicans in gnotobiotic rats. Microecol Ther 1 996; 24: 45-51.
– Mandel L et al. Stimulation ot intestinaL immune cells by E coli in gnotobiotic piglets. Adv. Mucosal lmmunol 1995; 463-464.
– Oelschlaeger TA et al. Inhibition of Salmonella typhimurium invasion into intestinal cells by the probiotic E coli strain Nissle 1917. Gastroenterology 2001 ; 120: 4326.
– Otte JM, Podolsky DK. Functional modulation of enterocytes by gram-positive and gramnegative microorganisms. Am J Physiol Gastrointest Liver Physiol 2004;286 (4): G613-626.
– Otte JM et al. Probiotics regulate the expression of COX-2 in intestinal epithelial cells. Nutr Cancer 2009; 61 (1): 1 03-113.
– Patzer S I et al. The colicin G, H and X determinants encode microcins M and H47, which might utilize the catecholate siderophore receptors FepA, Cir, Fiu and lroN. Microbiology 2003; 149: 2557-2570.
– Rasche C et al. Differential immunomodulating effects of inactivated probiotic bacteria on the allergic immune response. Acta Derm Venereol 2007; 87: 305-31 1
– Reissbrodt R et al. lnhibition of growth of Shiga toxin-producing Escherichia coli by nonpathogenic Escherichia coli. FEMS Microbiol Lett 2009; 290: 62-69.
– Schiemann M et al. 125 Jafie E.coli – Bedeutung in Forschung und Medizin. Alfred-Nissle-Gesellschaft (Hrsg.) Hagen, ISBN 3-98’11198-4-3, 2010.
– Schlee M et al. Induction of human beta-defensin 2 by the probiotic Escherichia coli Nissle 1917 is mediated through flagellin. lnfect lmmun 2007; 75(5): 2399-2407 .
– Schultz lV et al. Green fluorescent protein for detection of the probiotic bacterium Escherichia coli strain Nissle 1917 (EcN) in vivo. J Microbiological Methods 2005; 61 : 389-398.
– Schultz M et al. Preventive effects of Escherichia coli strain Nissle 1917 on acute and chronic intestinal inflammation in two different murine models of colitis. Clin Diagn Lab lmmunol 2004; 11 (2): 37 2-37 8.
– Schulze J et al. Probiotìka – lVikroòkologie, lvlikrobiologie, Qualitàt, Sicherheit und gesundheitliche Effekte. Hippokrates, Stuttgart, ISBN 978-3-8304-5356-7,2008.
– Sonnenborn U et al. Antimutagenic activity of the probiotic E.coli strain Nissle 1917. Journal of Crohn’s and Colitis 2009; 3: S 136.
– Sonnenborn U, Schulze J. The non-pathogenic Escherichia coli strain Nissle 1917 – features of a versatile probiotic. Microbial Ecol Health Dis 2009; 21:122-158.
– Splíchal I et al. The effect of intestinal colonization of germ-free pig s with Escherichia coli on calprotectin levels in plasma, intestinal and bronchoalveolar lavages. lmmunobiology 2005; 209: 681 -687.

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