Prophylaxis of unwanted microbial gut colonization with Mutaflor Suspension

E. coli strain Nissle 1917 colonizes the gut of newborn infants 

The ability of EcN to colonize the intestine of full-term and premature neonates has been investigated in various studies. To this end, one ml ­Mutaflor suspension containing 108 EcN bacteria were daily administered to neonates orally on the first to the fifth day of life. It was shown that EcN colonizes in the intestines on a long-term basis. 

Colonization in full-term neonates 

In breast-fed full-term neonates, EcN bacteria were recovered in the stools of 75 % of the treated children from the third day onward. On the fourteenth day, EcN could be determined in all children. The ­­Mutaflor strain was detectable in stools even sixteen days after the last application. 35 These results were corroborated by other studies which included comparison groups. 

The ­Mutaflor strain could still be detected in the feces even 6–12 months after the observation period and the application of the ­Mutaflor Suspension had ceased. 4; 36 Consequently, EcN colonizes the intestines of the newborn. 

Colonization in premature neonates

In premature neonates (birth weight < 2,500 g) EcN was detectable in the stools of all children as early as after three days of treatment, and this remained unaltered until the end of the observation period on Day 21.35

E. coli strain Nissle 1917 protects against the colonization with hazardous hospital-associated pathogens causing nosocomial infections 

This is the result of a study which examined the prophylactic effect of ­Mutaflor on infection and colonization under hospital conditions. Full-term neonates received 1 ml ­Mutaflor Suspension on five consecutive days. The results were compared with the data of a control group not treated with ­Mutaflor.16; 17

A variety of undesired pathogenic Enterobacteria­ceae,­ including hemolytic E. coli-bacteria, could only be detected in non-treated neonates. The protective ­Mutaflor strain was the dominant E. coli strain in all colonized neonates.4
EcN protects against enteroinvasive pathogenic bacteria and yeasts 16; 17


Colonization prophylaxis in newborns

The deliberate colonization with E. coli strain Nissle 1917 (EcN) and its prophylactic effects on infection and contamination with unwanted bacteria were examined in a double-blind placebo-controlled clinical study including 54 newborns (­Mutaflor group: N = 27, placebo group: N = 27). 36

All children were breast-fed in their first week of life. Stool samples were recovered on days 1, 2, 3, 5 and on day 21 as well as six months after birth. 

­Mutaflor was detected in the infant´s stools after the second day and remained to be so during the entire study period of six months, involving more than 90 % of the colonized children.
Pathogenic and/or potentially pathogenic bacteria were found on the day of birth in both the ­Mutaflor group and in the placebo group in 19 % of the newborns. As early as on the third day of life, however, the ­Mutaflor group displayed a significantly lower colonization rate of pathogenic microorganisms (p < 0.003). This advantage of ­Mutaflor administration increased until the last day of treatment (Day 5; p < 0.001) and remained to be so until 6 month after birth (p < 0.002).

In addition, the application of ­Mutaflor significantly reduced both the spectrum of microbial species and the cell counts of pathogenic and potentially pathogenic microbes (p = 0.008).

­Mutaflor tolerance was mostly rated as “very good” or “good”.

­Mutaflor improves cellular and humeral ­immunity of newborns

A clinical study with 31 newborns revealed a significant increase of IgA- and IgM-levels in stool filtrates and in the blood serum subsequent to a colonization with E. coli strain Nissle 1917. There was no increase of IgG-levels in the blood serum. The response in serum occurred with a delay relative to the local ­response in the gut. 35

Premature infants treated with EcN (N = 34) displayed an enhanced activity of blood leukocytes in whole blood also in comparison with other types of E. coli. Untreated premature infants (N = 27) did not display this activity enhancement. 37

The immune system of EcN-treated newborns is thus better prepared for warding off infections. It responds quicker to invading bacteria foreign to the body.

Mutaflor lowers the risk of infection in preterm infants after antibiotic therapy

In certain circumstances, the intensive-medical care of preterm infants requires the rapid application of antibiotic substances. However, there is the risk of spreading antibiotic resistances and damaging the gut microbiota which is in the stage of development. 

Enterobacteriaceae (Klebsiella and Proteus), hazardous to health, emerged in the colon of 16 premature infants. 87 % of the premature infants had been previously treated with antibiotics. These bacteria disappeared after the oral administration of ­Mutaflor Suspension in 75 % of the infants ­treated. 38

Results on the colonization of E. coli strain Nissle 1917 in the intestines of infants

  • EcN is detectable in stools as early as on the second or third day
  • EcN colonizes the intestines of infants on a long-term basis and thus protects against intestinal infection right after birth

4) Schröder H. Entwicklung der aeroben Darmflora bei Neugeborenen nach Kolonisierung mit dem E. coli-Stamm Nissle 1917. Der Kinderarzt 1992; 23(10): 1619–1625.

35) Lodinová-Žádníková 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 Immunol 1992; 3: 43–48.

36) Lodinová-Žádníková R, Sonnenborn U. 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.

37) 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 Immunol 2002; 55: 204–209.

38) Lodinová-Žádníková 1991, persönliche Mitteilung  

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