What Is Bifantis?

Bifantis is the trademarked name for the patented probiotic strain Bifidobacterium infantis 35624.

According to a definition developed by the Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO), probiotics are "live microorganisms, which, when administered in adequate amounts, confer a health benefit on the host."¹ An introduction to probiotics available from the National Institutes of Health's National Center of Complementary and Alternative Medicine (NCCAM) states that "Probiotics are live microorganisms (in most cases, bacteria) that are similar to beneficial microorganisms found in the human gut. They are also called 'friendly bacteria' or 'good bacteria.'² The NCCAM also states that "Most probiotics are bacteria similar to those naturally found in people's guts, especially in those of breast-fed infants (who have natural protection against many diseases)."² The NCCAM further states that "Each person's mix of bacteria varies. Interactions between a person and the microorganisms in his body, and among the microorganisms themselves, can be crucial to the person's health and well-being."²

The current evidence suggests that the beneficial effects of probiotics are strain specific.^3-5 According to the World Gastroenterology Organisation (WGO) Practice Guidelines on Probiotics and Prebiotics, the potential probiotic health benefits "can only be attributed to the strain or strains tested, and not to the species or the whole group of lactic acid bacteria or other probiotics."³

For more information/background about probiotics, click here.

Bifidobacteria

The normal healthy human gastrointestinal tract contains more than 100 trillion bacteria, including more than 500 different species.^6-8 The main health-enhancing bacteria are believed to be the bifidobacteria and lactobacilli.^9,10 Bifidobacteria are gram-positive, anaerobic bacteria that are considered key beneficial bacteria in human-microbe interactions, and are believed to play an important role in maintaining a healthy gastrointestinal tract.⁸ Bifidobacteria are one of the most predominant members of the human gastrointestinal microflora.^8,9 Infants are colonized by these microorganisms within days following birth.¹¹ Bifidobacteria have been shown to constitute up to 95% of the total gut bacterial population in infants, but decline to as low as 3% to 6% in adults.^8,9,12-15 Species distribution can be affected by diet, health status, travel, stress, and other factors.¹⁶

Criteria and Standards for Evaluation of Probiotics

A joint FAO/WHO Working Group has developed criteria and standards for the evaluation and labeling of probiotics for human consumption.⁴ The table below summarizes the guidelines and recommendations for strain identification, in vitro functional characterization, safety, and effectiveness.⁴ The FAO/WHO guidelines and recommendations also address product-specific criteria such as surveillance of adverse incidents and proper product labeling.⁴

Criteria and Standards for Evaluation of Probiotics

Criteria	Bifantis
STRAIN IDENTIFICATION
Strain identification by phenotypic and genotypic methods	Bifantis genome has been fully sequenced, and strain-specific criteria are used in manufacturing to ensure product quality and control.17
Nomenclature that conforms to current, scientifically recognized names (genus, species, strain)	Bifantis is the trademarked name for the patented probiotic strain Bifidobacterium infantis 35624.
Deposit strain in international culture collection	A deposit of Bifantis has been made at the National Collection of Industrial and Marine Bacteria Limited (NCIMB).
IN VITRO FUNCTIONAL CHARACTERIZATION
Resistance to gastric acid and bile	Bifantis is recovered from the feces following supplementation.17
Adherence to mucus and/or human epithelial cells and cell lines	Bifantis was isolated from a human intestinal epithelial tissue sample. Bifantis was isolated from the mucosa of the terminal ileum of a healthy adult.17
Ability to reduce pathogen adhesion to surfaces and antimicrobial activity against potentially pathogenic bacteria	In vitro studies have shown that Bifantis has pathogen inhibition activity.17 No specific in vitro studies have been performed to quantify the ability of Bifantis to reduce pathogen adhesion to surfaces.
SAFETY
Antibiotic resistance profile and potential for pathogenicity	The 35624 genome does not contain DNA-encoding proteins that could be implicated in virulence or pathogenicity.17 Bifantis is susceptible to antibiotics with gram-positive coverage, including ampicillin, ciprofloxacin, erythromycin, gentamycin, penicillin, vancomycin, etc.17 Bifantis is resistant to netilmicin, trimethoprim, sodium cefuroxime, metronidazole, and nalidixic acid.17
Assessment of certain metabolic activities (e.g., D-lactate production—which has been implicated in acidosis)	Bifantis is a unique strain of bifidobacteria. There are no reports in the literature of D-lactate production by genus Bifidobacterium.
Assessment of side effects during human studies	Probiotics' side effects, if they occur, tend to be mild and digestive (such as gas or bloating).2 In Bifantis clinical studies, there was no difference in side effects between Bifantis and placebo.18,19
EFFECTIVENESS
Clinical testing to evaluate product performance	Bifantis has been studied in preclinical and clinical studies.