FAQ

What is Mutaflor®?...and what is it used for?

Mutaflor® is a probiotic that comprises as its active substance a viable non-pathogenic strain of Escherichia coli (E.coli). First isolated in 1917 by Professor Alfred Nissle from the faeces of a soldier during the First World War who as he remarked, “in contrast to the large majority of his comrades, had suffered neither from dysentery nor from any other intestinal diseases”. Thereafter, appropriately named Escherichia coli strain Nissle 1917.

Mutaflor® is registered in Australia at AUST R level for the relief and management of chronic constipation. Your healthcare practitioner may also wish to utilise this strain for its pharmacological and metabolic properties.

Characteristics of Escherichia coli strain Nissle 1917.

the ability to colonize
antagonistic activity – inhibition of growth and or killing of pathogens
anti-invasive – prevention of colonisation in the gut by pathogens
synthesis of endogenous antimicrobial peptides-defensins
mucosal integrity – contributing to luminal metabolism and stability of intestinal milieu-enhanced epithelial barrier function
anti-inflammatory and immunomodulatory effects
stimulation of colonic mucosa

The therapeutic effects of Mutaflor® are strain specific and have been demonstrated by in-vitro and in-vivo experiments and clinical studies. Mutaflor® Escherichia coli strain Nissle 1917 (EcN) is arguably one of the best studied and field tested probiotic strains and fulfills all the demanding criteria and characteristics required for a medicinal probiotic.

Why Escherichia coli as a probiotic?

Escherichia coli is often associated with disease, but this single bacterial species has many different biotypes, some are commensal strains such as Escherichia coli strain Nissle 1917 (EcN).

As one of the first colonizers of the infant gut, Escherichia coli plays a vital role in the establishment and maintenance of a healthy gut and provides a microbial barrier against pathogenic bacteria. As a result of its numerous metabolic activities, Escherichia coli is responsible for the production of many essential metabolites. Escherichia coli produces chorismate (chorismic acid) which in turn is the precursor for:

folic acid
the amino acids, tryptophan
tyrosine, phenylalanine…and these in turn, the precursor to dopamine, a neurotransmitter.
ubiquinol(CoQ10)
menaquinone (Vit K2)

E.coli’s consumption of oxygen, production of short- chain fatty acids (SCFA) helps create an environment in which subsequent anaerobic microorganisms can establish and so begins this complex Gut Microbiome which will play a crucial role in our health.

Does Mutaflor® require refrigeration and it free from lactose, gluten, wheat or animal products?

Mutaflor® should be stored in the refrigerator at (2-8°C). A short break in refrigeration at room temperature (up to 72 hours or 3 days) will not harm the product. Delivery of Mutaflor® to Australia follows strict ‘Cold Chain’ processes. The specially designed pallet thermobox enables Mutaflor® to be air-freighted and temperature data logging confirms this process. Distribution within Australia is via ice filled foam cartons and is for most locations an overnight delivery. Mutaflor® does not contain lactose, gluten or wheat.

Does the number of colony forming units (CFU) matter or is it the quality of the strain?

Both are correct. Not only is having adequate numbers of living bacteria important – so too is the quality and viability of the strain. This hardiness depends on proper manufacturing, packing and storage of the product. Around the world, labeling for Mutaflor® will refer to bacterial counts of 2.5 to 25×10⁹ viable cells which reflects a bacterial range. This is done because no two batches will be the same and therefore it is inappropriate to assert a defined number and most importantly the bacterial count will differ from that at the time of manufacture. Australian labelling requirements does not allow for ranges.

Here, Mutaflor® will show the minimum viable cell count that would exist at the end of shelf life, as per product stability studies. So, while our label states ‘not less than 250 million CFU‘ recent batches of Mutaflor® were packaged with CFU’s of 1.2×10¹° or 12 billion colony forming units.

What is the shelf life of Mutaflor®

Mutaflor® has a shelf life of 12 months from date of batch manufacture.
To always ensure quality of the product, no batch will be released until examined for purity and upon release, a Certificate of Analysis is issued.
This process may result in the product having a shelf life of some 10 months once it arrives in Australia.

How long can Mutaflor® remain viable outside refrigeration?

While Mutaflor® should always be refrigerated 2-8°C, a short break – up to 72 hours at room temperature is possible without any loss of efficacy.