Skip to content

About Bifantis for Professionals

Learn more about the patented probiotic strain B. infantis 35624. Discover the potential health benefits of probiotics the proposed mechanisms of action, and the safety of probiotics. Review articles on probiotics, preclinical and clinical data on B. infantis 35624 and other scientific review articles on B. infantis 35624. And, if you're interested in obtaining even more information about probiotics, explore various other professional resources on the topic.

bifants ref

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.3-5 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


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

bi microscopy and bi em Image 1: Bifidobacterium infantis 35624 Microscopy photo of Bifidobacterium infantis 35624. Image 2: This photo shows the extra-cellular polysaccharide (EPS) coating of Bifidobacterium infantis 35624, a unique feature of some bifidobacteria.

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



  • Strain identification by phenotypic and genotypic methods
  • Nomenclature that conforms to current, scientifically recognized names (genus, species, strain)
  • Deposit strain in international culture collection


  • 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


  • 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


  • Clinical testing to evaluate product performance

Reference to institutions and agencies is provided for informational purposes only and does not suggest an endorsement or approval of Bifantis®.


1 Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Cordoba, Argentina, 2001 Oct 1-4. Available at:

2 National Center for Complementary and Alternative Medicine. National Institutes of Health. Get the facts. Oral probiotics: An introduction. Updated November 2011. Available at:

3 World Gastroenterology Organisation Global Guidelines. Probiotics and prebiotics. 2011 October. Available at:

4 Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food. London, Ontario, Canada. 2002 April 30-May 1. Available at:

5 Douglas LC, Sanders ME. Probiotics and prebiotics in dietetics practice. J Am Diet Assoc 2008 Mar;108(3):510-21.

6 Suau A, Bonnet R, Sutren M, Godon JJ, Gibson GR, Collins MD, Doré J. Direct analysis of genes encoding 16S rRNA from complex communities reveals many novel molecular species within the human gut. Appl Environ Microbiol. 1999 Nov;65(11):4799-807.

7 Berg RD. The indigenous gastrointestinal microflora. Trends Microbiol. 1996 Nov;4(11):430-45.

8 Leahy SC, Higgins DG, Fitzgerald GF, van Sinderen D. Getting better with bifidobacteria. J Appl Microbiol. 2005;98(6):1303-15

9 Picard C, Fioramonti J, Francois A, Robinson T, Neant F, Matuchansky C. Review article: bifidobacteria as probiotic agents—physiological effects and clinical benefits. Aliment Pharmacol Ther. 2005 Sep 15;22(6):495-512.

10 Salminen S, Bouley C, Boutron-Ruault MC, Cummings JH, Franck A, Gibson GR, Isolauri E, Moreau MC, Roberfroid M, Rowland I. Functional food science and gastrointestinal physiology and function.* Br J Nutr.* 1998 Aug;80 Suppl 1:S147-71.

11 Isolauri E, Salminen S, Ouwehand AC. Microbial-gut interactions in health and disease. Probiotics. Best Pract Res Clin Gastroenterol. 2004 Apr;18(2):299-313.

12 Harmsen HJ, Wildeboer-Veloo AC, Raangs GC, Wagendorp AA, Klijn N, Bindels JG, Welling GW. Analysis of intestinal flora development in breast-fed and formula-fed infants by using molecular identification and detection methods. J Pediatr Gastroenterol Nutr. 2000 Jan;30(1):61-7.

13 Favier CF, Vaughan EE, De Vos WM, Akkermans AD. Molecular monitoring of succession of bacterial communities in human neonates. Appl Environ Microbiol. 2002 Jan;68(1):219-26.

14 Hopkins MJ, Sharp R, Macfarlane GT. Age and disease related changes in intestinal bacterial populations assessed by cell culture, 16S rRNA abundance, and community cellular fatty acid profiles. Gut. 2001 Feb;48(2):198-205.

15 Satokari RM, Vaughan EE, Smidt H, Saarela M, Mättö J, de Vos WM. Molecular approaches for the detection and identification of bifidobacteria and lactobacilli in the human gastrointestinal tract. Syst Appl Microbiol. 2003 Nov;26(4):572-84.

16 Balamurugan R, Janardhan HP, George S, Chittaranjan SP, Ramakrishna BS. Bacterial succession in the colon during childhood and adolescence: molecular studies in a southern Indian village. Am J Clin Nutr. 2008 Dec;88(6):1643-7.

17 Fuller R. A review. Probiotics in man and animals. J Appl Bacteriol. 1989 May;66(5):365-78.

18 Salminen S, Deighton M. Lactic acid bacteria in the gut in normal and disordered states. Dig Dis. 1992;10:227-238.

19 Salminen S, Isolauri, Onnel T. Gut flora in normal and disordered states. Chemotherapy. 1995;41(Suppl 1):5-15.