Mutaflor

Mutaflor is a probiotic consisting of a viable non-pathogenic bacterial strain named Escherichia coli Nissle 1917. The Escherichia coli strain Nissle 1917, designated DSM 6601 in the German Collection for Microorganisms in Braunschweig, is one of the best-examined and therapeutically relevant bacterial strains worldwide.

The Mutaflor strain was isolated by Alfred Nissle (original, German spelling Nißle) in 1917 during the first world war. As such, the strain was named after him as Escherichia coli Nissle 1917. It has been clinically studied and reviewed for over 80 years to prevent and treat an assortment of gastrointestinal disorders. Mutaflor was prescribed by Theodor Morell to treat Adolf Hitler's gastrointestinal disorders, primarily flatulence.

Efficacy of Mutaflor for a variety of inflammatory bowel diseases has been tested through 80 years of clinical experience. There are numerous double-blind placebo-controlled studies showing the efficacy of Mutaflor in the treatment and prevention of gastrointestinal disorders.

For maintenance of remission of ulcerative colitis, there are 3 controlled, randomized, double blind (double-dummy) clinical studies which have proven equivalence of Mutaflor and the standard of care mesalazine (5-ASAs). These include Kruis et al. 1997, Rembacken et al.1999 and Kruis et al. 2004.

The recommended dose for prevention of relapse of ulcerative colitis or maintenance of remission of ulcerative colitis is one capsule per day for the first 4 days. Two capsules daily started on day 5

Two clinical studies have shown efficacy in the case of chronic constipation. These include Bruckschen et al. 1994 and. Möllenbrink et al. 1994

The recommended dose for adolescents (12–17) years old and adults (18 years and over) is one capsule per day during the first 4 days then two capsules daily starting on day 5.

Mutaflor (E. coli strain Nissle 1917) has no pathogenic characteristics: Although originally cultured from a minute quantity of intestinal flora it is raised and maintained on gelatin.

Of negative biosafety aspects tested, it was shown that there was no production of enterotoxins (Shiga toxins, heat-stable and heat-labile toxins), no production of cytotoxins (CNF), no invasiveness, no pathogenic adhesion factors (e.g. no CFA I/II, P, M and S fimbriae), no hemolysins, no serum resistance (i.e. no risk of sepsis), no uropathogenicity and no antibiotic-resistance genes.

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