Skip to main content
Top
Published in: International Journal of Colorectal Disease 4/2012

Open Access 01-04-2012 | Original Article

A double-blind placebo-controlled trial to study therapeutic effects of probiotic Escherichia coli Nissle 1917 in subgroups of patients with irritable bowel syndrome

Authors: Wolfgang Kruis, Sigrun Chrubasik, Stephan Boehm, Christiane Stange, Juergen Schulze

Published in: International Journal of Colorectal Disease | Issue 4/2012

Login to get access

Abstract

Purpose

To study the therapeutic effects of probiotic Escherichia coli Nissle 1917 (EcN) in irritable bowel syndrome (IBS) and identify subgroups benefiting most.

Background

Some trials investigating therapeutic effects in irritable bowel syndrome have shown benefits in IBS subgroups only. Probiotic treatment seems to be promising.

Methods

Patients with irritable bowel syndrome (120; Rome II) were recruited to a prospective double-blind study and randomized to either EcN (n = 60) or placebo (n = 60) given for 12 weeks. Objectives were to describe efficacy and safety of EcN in different groups of irritable bowel syndrome. Outcome was assessed by ‘Integrative Medicine Patient Satisfaction Scale’.

Results

Altogether, the responder rate was higher in the EcN than in the placebo group. However, only after 10 and 11 weeks, the differences were significant (Δ 20.0% points [95% CI 2.6; 37.4], p = 0.01 and Δ 18.3% points [95% CI 1.0; 35.7], p = 0.02, respectively). The best response was observed in the subgroup of patients with gastroenteritis or antibiotics prior to irritable bowel syndrome onset (Δ 45.7% points, p = 0.029). No significant differences were observed in any other subgroup. Both treatment groups showed similar adverse events and tolerance.

Conclusions

Probiotic EcN shows effects in irritable bowel syndrome, especially in patients with altered enteric microflora, e.g. after gastroenterocolitis or administration of antibiotics.
Literature
1.
2.
go back to reference Quigley EMM, Flourie B (2007) Probiotics and irritable bowel syndrome: a rationale for their use and an assessment of the evidence to date. Neurogastroenterol Motil 19(3):166–172PubMedCrossRef Quigley EMM, Flourie B (2007) Probiotics and irritable bowel syndrome: a rationale for their use and an assessment of the evidence to date. Neurogastroenterol Motil 19(3):166–172PubMedCrossRef
3.
go back to reference McFarland LV, Dublin S (2008) Meta-analysis of probiotics for the treatment of irritable bowel syndrome. World J Gastroenterol 14(17):2650–2661PubMedCrossRef McFarland LV, Dublin S (2008) Meta-analysis of probiotics for the treatment of irritable bowel syndrome. World J Gastroenterol 14(17):2650–2661PubMedCrossRef
6.
go back to reference Grozdanov L, Raasch C, Schulze J et al (2004) Analysis of the genome structure of the nonpathogenic probiotic Escherichia coli strain Nissle 1917. J Bacteriol 186(16):5432–5441PubMedCrossRef Grozdanov L, Raasch C, Schulze J et al (2004) Analysis of the genome structure of the nonpathogenic probiotic Escherichia coli strain Nissle 1917. J Bacteriol 186(16):5432–5441PubMedCrossRef
7.
go back to reference Grozdanov L, Zähringer U, Blum-Oehler G et al (2002) 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 184(21):5912–5925PubMedCrossRef Grozdanov L, Zähringer U, Blum-Oehler G et al (2002) 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 184(21):5912–5925PubMedCrossRef
8.
go back to reference Sonnenborn U, Schulze J (2009) The non-pathogenic Escherichia coli strain Nissle 1917—features of a versatile probiotic. Microb Ecol Health Dis 21(3–4):122–58CrossRef Sonnenborn U, Schulze J (2009) The non-pathogenic Escherichia coli strain Nissle 1917—features of a versatile probiotic. Microb Ecol Health Dis 21(3–4):122–58CrossRef
9.
go back to reference Möllenbrink M, Bruckschen E (1994) Behandlung der chronischen Obstipation mit physiologischen Escherichia-coli-Bakterien. Ergebnisse einer klinischen Studie zur Wirksamkeit und Verträglichkeit der mikrobiologischen Therapie mit dem E.-coli-Stamm Nissle 1917 (Mutaflor) [Treatment of chronic constipation with physiologic Escherichia coli bacteria. Results of a clinical study of the effectiveness and tolerance of microbiological therapy with the E. coli Nissle 1917 strain (Mutaflor)]. Med Klin 89(11):587–593 Möllenbrink M, Bruckschen E (1994) Behandlung der chronischen Obstipation mit physiologischen Escherichia-coli-Bakterien. Ergebnisse einer klinischen Studie zur Wirksamkeit und Verträglichkeit der mikrobiologischen Therapie mit dem E.-coli-Stamm Nissle 1917 (Mutaflor) [Treatment of chronic constipation with physiologic Escherichia coli bacteria. Results of a clinical study of the effectiveness and tolerance of microbiological therapy with the E. coli Nissle 1917 strain (Mutaflor)]. Med Klin 89(11):587–593
10.
go back to reference Henker J, Laass M, Blokhin BM et al (2007) The probiotic Escherichia coli strain Nissle 1917 (EcN) stops acute diarrhoea in infants and toddlers. Eur J Pediatr 166(4):311–318PubMedCrossRef Henker J, Laass M, Blokhin BM et al (2007) The probiotic Escherichia coli strain Nissle 1917 (EcN) stops acute diarrhoea in infants and toddlers. Eur J Pediatr 166(4):311–318PubMedCrossRef
11.
go back to reference Henker J, Laass MW, Blokhin BM et al (2008) Probiotic Escherichia coli Nissle 1917 versus placebo for treating diarrhea of greater than 4 days duration in infants and toddlers. Pediatr Infect Dis J 27(6):494–499PubMedCrossRef Henker J, Laass MW, Blokhin BM et al (2008) Probiotic Escherichia coli Nissle 1917 versus placebo for treating diarrhea of greater than 4 days duration in infants and toddlers. Pediatr Infect Dis J 27(6):494–499PubMedCrossRef
12.
go back to reference Kruis W, Fric P, Pokrotnieks J et al (2004) Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine. Gut 53(11):1617–1623PubMedCrossRef Kruis W, Fric P, Pokrotnieks J et al (2004) Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine. Gut 53(11):1617–1623PubMedCrossRef
13.
go back to reference Thompson WG, Longstreth GF, Drossman DA et al (1999) Functional bowel disorders and functional abdominal pain. Gut 45(suppl II):43–47 Thompson WG, Longstreth GF, Drossman DA et al (1999) Functional bowel disorders and functional abdominal pain. Gut 45(suppl II):43–47
14.
go back to reference Kruis W, Thieme C, Weinzierl M et al (1984) A diagnostic score for the irritable bowel syndrome. Its value in the exclusion of organic disease. Gastroenterology 87(1):1–7PubMed Kruis W, Thieme C, Weinzierl M et al (1984) A diagnostic score for the irritable bowel syndrome. Its value in the exclusion of organic disease. Gastroenterology 87(1):1–7PubMed
15.
go back to reference Steinsbekk A, Biolchini J, Heger M, Rezzani C, Tsamis N, van Haselen R et al (1999) Data collection in homeopathic practice: a proposal for an international standard. European Committee for Homeopathy. Data Collection Group (DCG), Trondheim, Norway Steinsbekk A, Biolchini J, Heger M, Rezzani C, Tsamis N, van Haselen R et al (1999) Data collection in homeopathic practice: a proposal for an international standard. European Committee for Homeopathy. Data Collection Group (DCG), Trondheim, Norway
16.
go back to reference Wong E, Guyatt GH, Cook DJ et al (1998) Development of a questionnaire to measure quality of life in patients with irritable bowel syndrome. Eur J Surg 164(suppl 583):50–56CrossRef Wong E, Guyatt GH, Cook DJ et al (1998) Development of a questionnaire to measure quality of life in patients with irritable bowel syndrome. Eur J Surg 164(suppl 583):50–56CrossRef
17.
go back to reference Chang L (2008) The trials and tribulations of drug development for functional gastrointestinal disorders. Neurogastroenterol Motil 20(Suppl 1):130–138PubMedCrossRef Chang L (2008) The trials and tribulations of drug development for functional gastrointestinal disorders. Neurogastroenterol Motil 20(Suppl 1):130–138PubMedCrossRef
18.
go back to reference Brenner DM, Moeller MJ, Chey WD et al (2009) The utility of probiotics in the treatment of irritable bowel syndrome: a systematic review. Am J Gastroenterol 104(4):1033–1049PubMedCrossRef Brenner DM, Moeller MJ, Chey WD et al (2009) The utility of probiotics in the treatment of irritable bowel syndrome: a systematic review. Am J Gastroenterol 104(4):1033–1049PubMedCrossRef
19.
go back to reference Talley NJ (2006) A unifying hypothesis for the functional gastrointestinal disorders: really multiple diseases or one irritable gut? Rev Gastroenterol Disord 6(2):72–78PubMed Talley NJ (2006) A unifying hypothesis for the functional gastrointestinal disorders: really multiple diseases or one irritable gut? Rev Gastroenterol Disord 6(2):72–78PubMed
21.
go back to reference Whorwell PJ, Altringer L, Morel J et al (2006) Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 101(7):1581–1590PubMedCrossRef Whorwell PJ, Altringer L, Morel J et al (2006) Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 101(7):1581–1590PubMedCrossRef
22.
23.
go back to reference Halvorson HA, Schlett CD, Riddle MS (2006) Postinfectious irritable bowel syndrome—a meta-analysis. Am J Gastroenterol 101(8):1894–1899PubMedCrossRef Halvorson HA, Schlett CD, Riddle MS (2006) Postinfectious irritable bowel syndrome—a meta-analysis. Am J Gastroenterol 101(8):1894–1899PubMedCrossRef
24.
go back to reference Collins SM (1996) The immunomodulation of enteric neuromuscular function: implications for motility and inflammatory disorders. Gastroenterology 111(6):1683–1699PubMedCrossRef Collins SM (1996) The immunomodulation of enteric neuromuscular function: implications for motility and inflammatory disorders. Gastroenterology 111(6):1683–1699PubMedCrossRef
25.
go back to reference Spiller RC (2004) Infection, immune function, and functional gut disorders. Clin Gastroenterol Hepatol 2(6):445–455PubMedCrossRef Spiller RC (2004) Infection, immune function, and functional gut disorders. Clin Gastroenterol Hepatol 2(6):445–455PubMedCrossRef
26.
go back to reference Hawrelak JA, Myers SP (2004) The causes of intestinal dysbiosis: a review. Altern Med Rev 9(2):180–197PubMed Hawrelak JA, Myers SP (2004) The causes of intestinal dysbiosis: a review. Altern Med Rev 9(2):180–197PubMed
27.
go back to reference Maxwell PR, Rink E, Kumar D et al (2002) Antibiotics increase functional abdominal symptoms. Am J Gastroenterol 97(1):104–108PubMedCrossRef Maxwell PR, Rink E, Kumar D et al (2002) Antibiotics increase functional abdominal symptoms. Am J Gastroenterol 97(1):104–108PubMedCrossRef
28.
go back to reference O'Mahony L, McCarthy J, Kelly P et al (2005) Lactobacillus and Bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology 128(3):541–551PubMedCrossRef O'Mahony L, McCarthy J, Kelly P et al (2005) Lactobacillus and Bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology 128(3):541–551PubMedCrossRef
29.
go back to reference Helwig U, Lammers KM, Rizzello F et al (2006) Lactobacilli, bifidobacteria and E. coli Nissle induce pro- and anti-inflammatory cytokines in peripheral blood mononuclear cells. World J Gastroenterol 12(37):5978–5986PubMed Helwig U, Lammers KM, Rizzello F et al (2006) Lactobacilli, bifidobacteria and E. coli Nissle induce pro- and anti-inflammatory cytokines in peripheral blood mononuclear cells. World J Gastroenterol 12(37):5978–5986PubMed
30.
go back to reference Bär F, von Koschitzky H, Roblick U et al (2009) Cell-free supernatants of Escherichia coli Nissle 1917 modulate human colonic motility: evidence from an in vitro organ bath study. Neurogastroenterol Motil 21:559–566PubMedCrossRef Bär F, von Koschitzky H, Roblick U et al (2009) Cell-free supernatants of Escherichia coli Nissle 1917 modulate human colonic motility: evidence from an in vitro organ bath study. Neurogastroenterol Motil 21:559–566PubMedCrossRef
31.
go back to reference Altenhoefer A, Oswald S, Sonnenborn U et al (2004) The probiotic Escherichia coli strain Nissle 1917 interferes with invasion of human intestinal epithelial cells by different enteroinvasive bacterial pathogens. FEMS Immunol Med Microbiol 40(3):223–229PubMedCrossRef Altenhoefer A, Oswald S, Sonnenborn U et al (2004) The probiotic Escherichia coli strain Nissle 1917 interferes with invasion of human intestinal epithelial cells by different enteroinvasive bacterial pathogens. FEMS Immunol Med Microbiol 40(3):223–229PubMedCrossRef
32.
go back to reference Wehkamp J, Harder J, Wehkamp K et al (2004) NF-k-B- and AP-1-mediated induction of human beta defensin-2 in intestinal epithelial cells by Escherichia coli Nissle 1917: a novel effect of a probiotic bacterium. Infect Immun 72(10):5750–5758PubMedCrossRef Wehkamp J, Harder J, Wehkamp K et al (2004) NF-k-B- and AP-1-mediated induction of human beta defensin-2 in intestinal epithelial cells by Escherichia coli Nissle 1917: a novel effect of a probiotic bacterium. Infect Immun 72(10):5750–5758PubMedCrossRef
33.
go back to reference Cichon C, Enders C, Sonnenborn U et al (2004) DNA-microarray-based comparison of cellular responses in polarized T84 epithelial cells triggered by probiotics: E. coli Nissle 1917 (EcN) and Lactobacillus acidophilus PZ1041. Gastroenterology 126(4):A-578–A-579 Cichon C, Enders C, Sonnenborn U et al (2004) DNA-microarray-based comparison of cellular responses in polarized T84 epithelial cells triggered by probiotics: E. coli Nissle 1917 (EcN) and Lactobacillus acidophilus PZ1041. Gastroenterology 126(4):A-578–A-579
Metadata
Title
A double-blind placebo-controlled trial to study therapeutic effects of probiotic Escherichia coli Nissle 1917 in subgroups of patients with irritable bowel syndrome
Authors
Wolfgang Kruis
Sigrun Chrubasik
Stephan Boehm
Christiane Stange
Juergen Schulze
Publication date
01-04-2012
Publisher
Springer-Verlag
Published in
International Journal of Colorectal Disease / Issue 4/2012
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-011-1363-9

Other articles of this Issue 4/2012

International Journal of Colorectal Disease 4/2012 Go to the issue