The influence of ­Mutaflor on the remission maintenance in patients with ulcerative colitis

In the guideline of the “European Crohn's & Colitis ­Organization” (ECCO) E. coli strain Nissle 1917 was acknowledged as an ­evidence-based medicinal substance belonging to the group of probiotics for the remission maintenance of ulcerative colitis.
In addition, the equivalence of ­Mutaflor and mesalazine was determined with regard to remission maintenance. 48

The influence of ­Mutaflor on the remission maintenance in patients with ulcerative colitis was examined in three randomized double-blind studies.

  • When administered in a dose of two capsules daily, ­Mutaflor was proved to be equally effective as mesalazine in this indication.

­Mutaflor versus Mesalazine

In the first of these studies, Kruis et al. 43 compared the remission behavior in 103 patients with ulcerative colitis under therapy with two capsules ­Mutaflor ­daily versus 3 x 500 mg mesalazine over a period of 12 weeks. No significant differences were determined between both groups with regard to the parameter “Clinical Activity Index” (CAI), “Relapse Rate” (16.0 % with ­Mutaflor versus 11.3 % with mesalazine) and “Time-to-Remission” (106 ± 5 days with ­Mutaflor versus 103 ± 4 days with mesalazine)

In another study 44, 116 ulcerative colitis patients had already been included in the study during an acute attack and treated with gentamicin 3 x 80 mg/d (Day 1–79) and prednisolone in slowly decreasing doses. The patients received either 2 x 2 capsules of ­Mutaflor/d or mesalazine 3 x 800 mg/d as test medication.

When a state of remission was reached, maintenance therapy proceeded with 2 x 1 capsule of ­Mutaflor/d or 3 x 400 mg/d mesalazine over a period of 12 months. The median duration of remission amounted to 185 (Mutaflor) and/or 175 days, respectively.

Plot of remission curves 44

  • No significant differences were determined between the Mutaflor and the Mesalazine group

In the third major study 45, which was carried out in ten European countries, 327 patients with ulcerative colitis in remission could be included and received either 1.5 g mesalazine or 1 x 2 capsules of ­Mutaflor daily, for the duration of one year. 222 patients (122 patients with mesalazine, 110 patients with ­Mutaflor) completed the study in conformity with the protocol. 38/112 patients in the measalzine group (33.9 %) and 40/110 patients in the ­Mutaflor group (36.4 %) revealed a relapse.

The equivalence of both pharmaceuticals was corroborated with a statistical significance of p = 0.003, hence both products were equally effective. 45

Relapse rate within one year45

  • both products were equally effective

The rectal instillation of E. coli strain Nissle 1917 – Mutaflor versus Placebo

The rectal instillation of E. coli strain Nissle 1917 produces a dose-dependent improvement of the clinical, endoscopic and histological findings of an active mild to moderate distal ulcerative colitis (DAI 4-9 (Disease Activity Index after Sutherland)). This is the result of a per-protocol analysis with 57 patients who received various volumes (10 ml, 20 ml or 40 ml) of a placebo or E. coli strain Nissle 1917 (108 CFU/ml) rectally over a maximum of eight weeks. Remission (DAI of ≤ 2) was reached in the placebo-group 2/11 (18.2 %), the
10-ml-E. coli strain Nissle 1917 group 3/11 (27.3 %), the 20-ml-E. coli strain Nissle 1917-group 8/18 (44.4 %) and the 40-ml-E. coli strain Nissle 1917-group 9/17 (52.9 %).
There were no significant differences between placebo and EcN as far as tolerance is concerned. 47

Remission rate after rectal ­application of E. coli strain Nissle 1917 or placebo47

43) Kruis W et al. Double-blind comparison of an oral Escherichia coli ­preparation and mesalazine in maintaining remission of ulcerative colitis. Aliment Pharmacol Ther 1997; 11: 853–858.

44) Rembacken BJ et al. Non-pathogenic Escherichia coli versus mesalazine for the treatment of ulcerative colitis: a randomised trial. Lancet 1999; 354: 635–639.

45) 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: 1617–1623.

47) 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.

48) Travis SPL et al. European evidence-based Consensus on the management of ulcerative colitis: Current management. Journal of Crohn‘s and Colitis 2008; 2(1): 24–62.

Mutaflor international package insert to download
Mutaflor Suspension international package insert to download