What Is Bifantis (B. infantis 35624)?

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, "Probiotics are live microorganisms (e.g., bacteria) that are either the same as or similar to microorganisms found naturally in the human body and may be beneficial to health."² The NCCAM also states that "most probiotics are bacteria similar to the beneficial bacteria found naturally in the human gut."²

The current evidence suggests that the beneficial effects of probiotics are strain specific.^3-5According 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 additional scientific information and data regarding Bifantis, 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, antibiotic use, travel, stress, and other factors.^16-19

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
STRAIN IDENTIFICATION
Strain identification by phenotypic and genotypic methods
Nomenclature that conforms to current, scientifically recognized names (genus, species, strain)
Deposit strain in international culture collection
IN VITRO FUNCTIONAL CHARACTERIZATION
Resistance to gastric acid and bile
Adherence to mucus and/or human epithelial cells and cell lines
Ability to reduce pathogen adhesion to surfaces and antimicrobial activity against potentially pathogenic bacteria
SAFETY
Antibiotic resistance profile and potential for pathogenicity
Assessment of certain metabolic activities (e.g., D-lactate production—which has been implicated in acidosis)
Assessment of side effects during human studies
EFFECTIVENESS
Clinical testing to evaluate product performance

References: