Bifidobacterium, BB-12®.pdf

•High gastric acid and bile tolerance compared to other
bifidobacteria. These properties enhance the potential of BB-12®
to provide a health benefit to the host1.
• it contains bile salt hydrolase which provide an advantage for
the cell as it allows a quick response to high bile salt
concentrations and thus facilitates the viable passage from the
small intestine to the large intestine. It is is well-equipped to
endure this critical passage in the gastrointestinal tract1.
• has strong mucus adherence properties. possesses the capability
to transiently colonize the mucosal surfaces in the intestine,
persist at these sites, in addition to pathogen inhibition, immune
interactions, and barrier function enhancement. Thereby, it
increase the possibility of delivering beneficial health effects.1
Bifidobacterium, BB-12®
Characteristics & Mechanisms (FEATURE)

Main molecular mechanisms involved in the response of BB-12 to different stresses.
(A) Bile is detoxified from the cytoplasm by the activity of bile efflux pumps and/or multidrug transporters. Conjugated bile
acids are deconjugated by the bile salt hydrolase, although the relationship of this enzyme with the resistance to bile is
unclear.
(B) Both bile and heat shock induce protein aggregation and misfolding, which is counteracted by the action of chaperones
and proteases.
(C) The F1F0-ATPase is used by bifidobacteria for counteracting the cytoplasm acidification that occurs in acidic
environments. In addition, production of branched-chain amino acids is coupled with glutamine deamination, rendering
ammonia that acts as a cytoplasmic buffer.
Genes & Nutrition, 6, 307-318.https://doi.org/10.1007/s12263-010-0207-5

•-The world’s most documented probiotic Bifidobacterium1,2
•- was discovered and isolated from the feces sample of a
breastfed human infant in 1899 from Chr. Hansen’s collection of
dairy cultures and has high stability in foods and as freeze dried
powders1,2 .
•- has strong mucus adherence properties. possesses the capability
to transiently colonize the mucosal surfaces in the intestine, persist
at these sites, in addition to pathogen inhibition, immune
interactions, and barrier function enhancement. Thereby, it
increase the possibility of delivering beneficial health effects.1, 2.

•Displaced pathogenic gastrointestinal bacteria through
production of antimicrobial substance as well as through
competition for mucosal adhesion1. Pathogen inhibition is
facilitated through multiple mechanisms including: production of
inhibitory substances (organic acids, H2O2, bacteriocins); nutrient
competition; toxin removal/degradation; competition for sites of
adherence (mucus, cell receptors); co-aggregation and virulence
modulation; and induction of host immune responses1

•-Barrier function enhancement is one of the central and
generally accepted mechanisms of probiotics. Maintenance
of an intact and functional mucus layer and epithelial cell
lining in the gastrointestinal tract is critical in order to stay fit
and healthy.1
•-Clinical studies have demonstrated survival of BB-12®
through the gastrointestinal tract1, 2.
•- immune interaction by increasing local and systemic
antibody production, modulating signals in epithelial and
immune cells, and by induction of phenotypic changes in
dendritic cells1.

Infants and children
•Gastrointestinal health
- Associated with reduced incidence of acute diarrhea,2 softer and more frequent
bowel movements,3 and fewer and shorter episodes of diarrhea.4
Excessive crying and fussing*
-Associated with a significant reduction in excessive crying and fussing in in infants
with colic.5
In clinical studies, Bifidobacterium, BB-12® has been
associated with beneficial effects across different areas of
health

Bifidobacterium animalis subsp. lactis BB-12 Protects against
Antibiotic-Induced Functional and Compositional Changes in Human
Fecal Microbiome
Nutrients 2021, 13(8), 2814; https://doi.org/10.3390/nu13082814
Concurrent administration of amoxicillin/clavulanate and BB-12 yogurt, to healthy
subjects, was associated with a significantly smaller decrease in the fecal SCFA levels
and a more stable taxonomic profile of the microbiota over time than the control
group.

The therapeutic
efficacy of
Bifidobacterium
animalis subsp.
lactis BB‐12® in
infant colic: A
randomised,
double blind,
placebo‐controlled
trial
Alimentary Pharmacology & Therapeutics, Volume: 51,
Issue: 1, Pages: 110-120, First published: 03 December
2019, DOI: (10.1111/apt.15561)

The therapeutic
efficacy of
Bifidobacterium
animalis subsp. lactis
BB‐12® in infant
colic: A randomised,
double blind,
placebo‐controlled
trial
Alimentary Pharmacology & Therapeutics, Volume: 51,
Issue: 1, Pages: 110-120, First published: 03 December
2019, DOI: (10.1111/apt.15561)

Individual SCFA expressed as a percent of total SCFA. (A-B) Comparison of all SCFA over time
with (A) Control, (B) Active. (C-E) Comparison of control and active for each individual SCFA with
(C) acetate, (D) butyrate, (E) propionate. Total SCFA is the sum of acetate, butyrate, and
propionate

Fecal Microbiome
Concurrent administration of amoxicillin/
clavulanate and BB-12 yogurt, to healthy
subjects, was associated with a significantly
smaller decrease in the fecal SCFA levels and a
more stable taxonomic profile of the microbiota
over time than the control group.

Our study demonstrated that both SCFA levels and microbiome
changes were attenuated by the BB-12 yogurt.
Importantly, B. animalis was not detected in the feces of subjects
in the BB-12 group on days 21 and 30, although SCFA and
microbiome changes persisted to day 30, which was the last day
we examined.
This suggests that BB-12 may have initiated changes to the
microbiome, perhaps via the cross-feeding of resident microbes
or other mechanisms, resulting in lasting, beneficial effects that
were not dependent on high levels of BB-12.
Fecal Microbiome
Nutrients 2021, 13, 2814. https://doi.org/10.3390/nu13082814

The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12® in
infant colic: A randomised, double blind, placebo‐controlled trial
Aliment Pharmacol Ther. 2019;00:1–11
The values of innate and acquired
immunity biomarkers, calprotectin and
butyrate faecal levels at baseline
during the week before treatment
(V0‐V1, blue bars) and during the last
week of treatment (V4‐V5, light blue
bars) in the two study groups.
Panel A: human β‐defensin 2;
panel B: cathelecidin (LL‐37);
panel C: secretory IgA;
panel D: butyrate;
panel E: calprotectin.
Values are expressed as mean and SD
and asterisks indicate a significant
difference (* = P < 0.05).

.The boxplots showing the variation
(V5‐V1) of crying time (in minutes), beta‐
defensin 2, LL‐37, sIgA, butyrate and
faecal calprotectin levels in subjects
classified in Cluster 1 or 2. Boxes
represent the interquartile range (IQR)
between the first and third quartiles, and
the line inside represents the median
(2nd quartile). Whiskers denote the
lowest and the highest values within 1.5 ×
IQR from the first and third quartiles
respectively. Asterisks indicate a
significant difference as obtained by
pairwise Wilcoxon test (P < 0.05.
calprotectin features have been explored
by only few authors with conflicting
results.47,48 We found a different
modulation of calpro‐ tectin in responder
infants to BB‐12 intervention, suggesting
that calprotectin could be involved in the
modulation of the gut inflam‐ matory
state elicited by this probiotic.

The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12® in infant colic: A randomised, double
blind, placebo‐controlled trial
Alimentary Pharmacology & Therapeutics, Volume: 51, Issue: 1, Pages: 110-120, First published: 03 December 2019, DOI: (10.1111/apt.15561)

In conclusion, our study provides compelling evidences for
the efficacy of Bifidobacterium animalis subsp. lactis BB‐12
in the treat‐ ment of IC. These evidences further support
the important role of gut microbiota as target of
intervention against IC. It is relevant to underline that this
trial studied a specific well‐characterised probiotic strain,
and that these findings cannot be extrapolated for other
probiotic strain.

The therapeutic efficacy of Bifidobacterium animalis subsp. lactis
BB‐12® in infant colic: A randomised, double blind, placebo‐controlled trial
Administration of BB‐12 at a daily dose of 1 × 109 CFU was
associ‐ ated with treatment success (defined as the
percentage of infants who achieved a reduction in the daily
average crying time ≥50%) and reduced crying time, with
beneficial effects on sleep duration and on stool frequency
and consistency. The clinical effect on daily average crying
time was already evident on the first week of treatment in
infants receiving BB‐12. All these variables have been
considered as clinically relevant in previous clinical trials and
meta‐analyses.
•Sung V, Cabana MD, D'Amico F, et al. Lactobacillus reuteri DSM 17938 for managing infant colic: protocol for an individual partici‐ pant
data meta‐analysis. BMJ Open. 2014;4:e006475.
•Sung V, D'Amico F, Cabana MD, et al. Lactobacillus reuteri to treat infant colic: a meta‐analysis. Pediatrics. 2018;141:e20171811. https
://doi.org/10.1542/peds.2017-1811.
• Dryl R, Szajewska H. Probiotics for management of infantile colic: a systematic review of randomized controlled trials. Arch Med Sci.
2018;14:1137‐1143. https://doi.org/10.5114/aoms.2017.66055.
•de Weerth C, Fuentes S, Puylaert P, de Vos WM. Intestinal micro‐ biota of infants with colic: development and specific signatures.
Pediatrics. 2013;131:e550‐e558.

The study has several strengths.
•Main strengths are the ran‐ domised, double blind,
placebo‐controlled design,
•the use of validated procedure for IC diagnosis and the use of a
well‐defined probiotic strain with a well characterised genome
sequence.
•Bifidobacteria have been asso‐ ciated with decreased amounts of
crying
•Infants treated with BB‐12 showed a higher increase of all
immunity bio‐ markers (HBD‐2, LL‐37 and of sIgA) compared to
subjects in the placebo group, suggesting that this probiotic strain
is able to exert an immunomodulatory action in the infant gut
previously reported(Lopez et al2010, Latvala etal,2008)

In a randomized, double-blind, placebo-controlled study by Pitkala et al. 2007 [27], BB-12® was
shown to improve bowel movement by 35%. The number of subjects experiencing normal
bowel movements in more than 30% of the days was increased by 114% in the BB-12® group
J Nutr Health Aging. 2007 Jul-Aug; 11(4):305-11.
bowel
movement%

Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12®, on defecation
frequency in healthy subjects with low defecation frequency and abdominal discomfort: a
randomised, double-blind, placebo-controlled, parallel-group trial
Br J Nutr. 2015 Nov 28; 114(10): 1638–1646
CFU, colony-forming units. ,
1 billion CFU, n 343; ,
10 billion CFU, n 452; ,
placebo, n 453.
intention-to-treat population analysis.
In conclusion, the results of this study strongly support a clinically relevant benefit of the
probiotic strain Bifidobacterium animalis subsp. lactis, BB-12®, on defecation frequency in
healthy subjects with low defecation frequency and abdominal discomfort. The efficacy of the
two doses was similar, indicating that there is a ceiling effect – the reason for this being
unknown at this point in time.

Beneficial health effects of BB-12® have been demonstrated
through clinical research. Survival of BB-12® through the
gastrointestinal tract has been demonstrated and BB-12® has been
shown to support a healthy gastrointestinal microbiota.
Furthermore, BB-12® has been shown to improve bowel function,
to have a protective effect against diarrhea, and to reduce side
effects of antibiotic treatment. In terms of immune function,
clinical studies have shown that BB-12® increases the body’s
resistance to common respiratory infections as well as reduces the
incidence of acute respiratory tract infections.
In conclusion BB-12® has well-established probiotic characteristics
and proven beneficial health effects within gastrointestinal health
and immune function.
Microorganisms. 2014 Jun; 2(2): 92–110

•Upper respiratory tract health
Associated with a reduced frequency of respiratory
infections.6, 7, 8
In clinical studies, Bifidobacterium, BB-12® has been associated
with beneficial effects across different areas of health

Bifidobacterium animalis subsp. lactis BB-12 in
reducing the risk of infections in early childhood
Pediatric Research volume 79, pages65–69 (2016)
The infants receiving BB-12 were reported to have
experienced fewer respiratory tract infections
(RTIs; 87 vs. 100%; risk ratio: 0.87; 95% confidence
interval: 0.76, 1.00; P = 0.033) than the controls.
Administration of BB-12 in early childhood may
reduce RTIs

Bifidobacterium animalis subsp. lactis BB-12 in
reducing the risk of infections in infancy
However, the infants receiving BB-12 (daily dose of BB-12 10
billion colony-forming units from the age of 1-2 months to 8
months ) were reported to have experienced fewer
respiratory infections (65 v. 94%; risk ratio 0·69; 95% CI 0·53,
0·89; P = 0·014) than the control infants. Controlled
administration of BB-12 in early childhood may reduce
respiratory infections
February 2011; The British journal of nutrition 105(3):409-16

BB-12® reduced the risk of respiratory tract infections in a study by Taipale et al. 2011 [42]. In
this randomized, double-blind, placebo-controlled BB-12® was administered using a slow-
release tablet in a pacifier.
Br J Nutr. 2011 Feb; 105(3):409-16.

Immune function
Associated with heightened immune response (as evidenced by increased anti-
rotavirus- and anti-poliovirus-specific IgA following immunization).9

Bifidobacterium lactis Ameliorates the Risk of Food Allergy in Chinese
Children by Affecting Relative Percentage of Treg and Th17 Cells
Canadian Journal of Infectious Diseases and Medical Microbiology Volume 2018, Article ID 4561038, 12 pages https://doi.org/10.1155/2018/4561038

Bifidobacterium lactis Ameliorates the Risk of Food Allergy in Chinese Children by Affecting Relative Percentage of Treg and
Th17 Cells
Canadian Journal of Infectious Diseases and Medical Microbiology Volume 2018, Article ID 4561038, 12 pages https://doi.org/10.1155/2018/4561038

•B. lactis induced a significant tolerance reaction for allergy
symptom reactions on food specific IgE of food in children . by
increasing Treg cells differentiation and suppressing )17-type cells
differentiation .
•related molecular mechanism may be involved with the balance
of the Treg/ )17 cells. B. lactis treatment significantly increased the
expression of FoxP3 and TGF-β related to Treg cells and reduced
the expression of IL-17A and IL-23 related to )17 cells
•The results were consistent with a previous report that B. lactis
promoted potentially antiallergenic processes throughinduction of
)1-type immunity and enhanced the regulatory lymphocyte (Kim
etal,2008).
Bifidobacterium lactis Ameliorates the Risk of Food Allergy in Chinese
Children by Affecting Relative Percentage of Treg and Th17 Cells
Canadian Journal of Infectious Diseases and Medical Microbiology Volume 2018, Article ID 4561038, 12 pages
https://doi.org/10.1155/2018/4561038

Change from baseline (U/ml) in (a, b) vaccine-specific
plasma IgG, IgG1 and IgG3, and (c, d) vaccine-specific
salivary IgG, IgA and IgM for the Bifidobacterium
animalis ssp. lactis (BB-12®,
the consumption of the probiotic strains
BB-12® significantly increases antigen-
specific immune responses in healthy
individuals receiving an influenza
vaccination. The elicitation and
strengthening of multiple and
complementary effector mechanisms
demonstrated in the present study are
considered to be associated with optimal
protection against mucosally transmitted
pathogens, such as the influenza virus. The
data also confirmed that dietary
supplementation with strains BB-12 results
in the elicitation of antigen-specific
responses alone and not in a potentially
harmful generalised immune activation, as
shown by the lack of effect on the plasma
titres of tetanus-specific antibodies. Dietary
supplementation with BB-12® may thus be a
safe and effective means to improve
immune function by augmenting the
response to challenges.
Br J Nutr 2012 Mar;107(6):876-84

Bifidobacterium lactis Bb12 enhances intestinal antibody response in
formula-fed infants: a randomized, double-blind, controlled trial
Conclusions: Infants consuming formula with Bb12 produced feces with detectable
presence of Bb12 and augmented sIgA concentration. Furthermore, cesarean-
delivered infants consuming Bb12 had heightened immune response, as evidenced by
increased anti-rotavirus- and anti-poliovirus-specific IgA following immunization.
These results demonstrate that negative immune-related effects of not breastfeeding
and cesarean delivery can be mitigated by including Bb12 in infant formula, thereby
providing infants a safe, dietary, immune-modulating bacterial introduction.
, JPEN J Parenter Enteral Nutr; 012 Jan;36(1 Suppl):106S-17S

In a randomized, double-blind, placebo-controlled study by Rizzardini et al. 2012 [40], BB-
12® was shown to improve immune function.
Br J Nutr. 2012 Mar; 107(6):876-84.

Immune function
Associated with heightened immune response (as evidenced by increased anti-
rotavirus- and anti-poliovirus-specific IgA following immunization).9
•Skin health*
Associated with reduced severity, extent and subjective symptoms of atopic eczema
in infants with inflammation/atopic exczema.10

Front. Immunol., 01 October 2019 | https://doi.org/10.3389/fimmu.2019.02348
A) bifidobacterial extracellular structures-mediated interaction with the host immune system. Pili are
depicted as black appendages (Pili+) while exopolysaccharides structures (EPS+) are displayed as light blue
layers around the cells. Blue bifidobacterial shapes correspond to bifidobacterial strains.
(B) Exhibits the cross-feeding effects between species of the Bifidobacterium genus and butyrate-producing
bacteria. Acetate and lactate produced by bifidobacterial species by degrading mucin, HMO or diet-derived
glycans become carbon sources for butyrate-producing microorganisms, stimulating a butyrogenic effect. At
the bottom of the image, host immune system cells are represented.

In recent decades, a growing number of studies have demonstrated that changes in the
intestinal microbial composition and gut homeostasis is directly linked to intestinal disorders
resulting, in the most severe cases, in IBD and colorectal cancer. The modulation of the gut
microbiota through prebiotics and/or probiotics is one of the ways to counteract these
dysbiosis, improving human health.
In this context, bifidobacteria are generally considered as potent probiotics for their health-
promoting features. Indeed, they trigger immunomodulatory responses aimed at maintaining
the host intestinal homeostasis through different mechanisms such as production of
extracellular structures that can interact with other intestinal microorganisms and/or the host
cells coupled with the release of by-products of their metabolism that may be utilized by other
commensal bacteria, such as the butyrate-producing microorganisms, to establish a cross-
feeding interaction.
However, despite their key role in stimulating human health and development in technology, the
precise mechanism by which bifidobacteria solicit an immune response is far from being fully
understood.
Indeed, most studies intended to correlate bifidobacteria and their immune modulatory effects
have been carried out by exploiting cell lines and/or animal models, thus preventing a
comprehensive understanding of the impact that bifidobacteria may exert on the human
immune system. Indeed, because of the complexity of the gut microbiota, in case of in
vivo studies it is possible that the presence of other bacterial strains may influence or even
reverse the bifidobacterial immunomodulatory effects. Therefore, the challenge for future
studies is to deepen the knowledge about this field, overcoming the abovementioned limits.
Front. Immunol., 01 October 2019 | https://doi.org/10.3389/fimmu.2019.02348

Efficacy of Bifidobacterium animalis subsp. lactis, BB-12 ® on infant colic - a randomised,
double-blinded, placebo-controlled study
enef Microbes2021 Sep 22;1-10. doi: 10.3920/BM2020.0233
Dose:daily BB-12 (1×109 cfu/day) or placebo for 3 week
At the end of the intervention the parent's/caregiver's
physical, emotional and social functioning scores were
significantly higher for the BB-12 group compared to the
placebo group (all P<0.05). Supplementation of BB-12 is
effective in reducing crying and fussing in infants
diagnosed with infant

Comparisons of fecal SCFA levels
and Shannon diversity at baseline
with multiple time points post
amoxicillin/clavulanate
administration. (A–C) % change in
average SCFA levels as compared to
post run-in (day 0) baseline.
(A) Acetate,
(B) propionate,
(C) butyrate.
The acetate control group (red) in (A)
remains decreased at day 30 (−25.1%)
whereas active (blue, BB-12) group
returns to baseline at day 30 (−1.6%).
(D) Correlation of Shannon diversity
between pre- and post-baseline values
(Spearman’s rank correlation coefficient
R = 0.49, p < 0.05).
(E) Differences in Shannon diversity
between the control (red) and BB-12
(blue) groups at time points pre
(baseline 1, day 30), post (baseline 2,
day 0), day 7, day 14, day 21, and day 30

Bifidobacterium animalis subsp. lactis BB-12 Protects against Antibiotic-Induced Functional
and Compositional Changes in Human Fecal Microbiome
Percent community divergence (Bray–Curtis dissimilarity) over time with respect to the
baseline (post run-in, day 0). Control group (blue bar graphs) exhibits overall greater
increase in community dissimilarity when compared to BB-12 recipients (red bar graphs).

. Conclusions: Infants consuming formula with Bb12 produced
feces with detectable presence of Bb12 and augmented sIgA
concentration. Furthermore, cesarean-delivered infants
consuming Bb12 had heightened immune response, as
evidenced by increased anti-rotavirus- and anti-poliovirus-
specific IgA following immunization. These results demonstrate
that negative immune-related effects of not breastfeeding and
cesarean delivery can be mitigated by including Bb12 in infant
formula, thereby providing infants a safe, dietary, immune-
modulating bacterial introduction. (JPEN J Parenter Enteral Nutr.
2012;36:106S-117S)
Bifidobacterium lactis Bb12 Enhances Intestinal Antibody
Response in Formula-Fed Infants: A Randomized, Double-Blind,
Controlled Trial

Adults
•Oral health*
Defecation frequency†
Associated with increased defecation frequency in adult populations with
infrequent bowel movements,12, 13 and in an elderly, frail nursing-home
population.14
Immune function*
•Associated with a strengthened immune response (as evidenced by increased
anti-influenza antibodies following immunization).15
Cholesterol#
Associated with a reduction in total cholesterol and LDL cholesterol in patients
with type 2 diabetes.16
In clinical studies, Bifidobacterium, BB-12® has been associated with beneficial effects across different
areas of health
Caglar E, et al. Short-term effect of ice-cream containing Bifidobacterium lactis Bb-12 on the number of salivary mutans streptococci and lactobacilli. Acta Odontol
Scand. 2008;66(3):154-8.
13. Eskesen D, et al. Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12®, on defecation frequency in healthy subjects with low defecation
frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial. Br J Nutr. 2015;114(10):1638-46.
14. Uchida K, et al. Effect of fermented milk containing Bifidobacterium lactis BB-12 on stool frequency,defecation , fecal microbiota and safety of excessive
ingestion in healthy female students. J. of Nutritional Food. 2005;8:3951.
15. Pitkala KH, et al. Fermented cereal with specific bifidobacteria normalizes bowel movements in elderly nursing home residents. A randomized,
controlled trial. J Nutr Health Aging. 2007;11(4):305-11

Bifidobacterium animalis subsp. lactis BB-12 Improves the State
Anxiety and Sports Performance of Young Divers Under Stress
Situations: A Single-Arm, Prospective Proof-of-Concept Study
Front. Psychol., 13 January 2021 | https://doi.org/10.3389/fpsyg.2020.570298
this study showed that the daily intake of Bifidobacterium animalis subsp. lactis
BB-12 (1 × 109 colony-forming units/100 g) daily for 8 weeks was effective in
reducing the state anxiety of athletes and could improve the performance of
athletes under stress. In addition, the intake of B.
animalis subsp. lactis increased the abundance of Bifidobacteriaceae in
athletes. This study demonstrated the potential of probiotics to improve mental
and anxiety state and performance in athletes under stress.

Clin Exp Allerg. 2000 Nov;30(11):1604-10.
doi: 10.1046/j.1365-2222.2000.00943.x.
Probiotics in the management of atopic eczema
E Isolauri 1, T Arvola, Y Sütas, E Moilanen, S Salminen
Abstract
Background: Over the last two decades the incidence of allergic diseases has increased in industrialized
countries, and consequently new approaches have to be explored.
Objective: The potential of probiotics to control allergic inflammation at an early age was assessed in a
randomized double-blind placebo-controlled study.
Methods: A total of 27 infants, mean age 4.6 months, who manifested atopic eczema during exclusive breast-
feeding and who have had no exposure to any infant or substitute formula were weaned to probiotic-
supplemented, Bifidobacterium lactis Bb-12 or Lactobacillus strain GG (ATCC 53103), extensively hydrolysed
whey formulas or to the same formula without probiotics. The extent and severity of atopic eczema, the growth
and nutrition of infants, and concentrations of circulating cytokines/chemokines and soluble cell surface adhesion
molecules in serum and methyl-histamine and eosinophilic protein X in urine were determined.
Results: The SCORAD score reflecting the extent and severity of atopic eczema was 16 (7-25) during breast-
feeding, median (interquartile range). After 2 months, a significant improvement in skin condition occurred in
patients given probiotic-supplemented formulas, as compared to the unsupplemented group; chi(2) = 12.27, P =
0.002. SCORAD decreased in the Bifidobacterium lactis Bb-12 group to 0 (0-3.8), and in the Lactobacillus GG
group to 1 (0.1-8.7), vs unsupplemented 13.4 (4.5-18.2), median (interquartile range), in parallel with a reduction
in the concentration of soluble CD4 in serum and eosinophilic protein X in urine.
Conclusion: The results provide the first clinical demonstration of specific probiotic strains
modifying the changes related to allergic inflammation. The data further indicate that probiotics
may counteract inflammatory responses beyond the intestinal milieu. The combined effects of
these probiotic strains will guide infants through the weaning period, when sensitization to newly
encountered antigens is initiated. The probiotic approach may thus offer a new direction in the
search for future foods for allergy treatment and prevention strategies.

. Br J Nutr;2015 Nov 28;114(10):1638-46.doi: 10.1017/S0007114515003347. Epub 2015 Sep 18.
Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12®, on defecation
frequency in healthy subjects with low defecation frequency and abdominal discomfort: a
randomised, double-blind, placebo-controlled, parallel-group trial
Dorte Eskesen 1, Lillian Jespersen 1, Birgit Michelsen 1, Peter J Whorwell 2, Stefan Müller-Lissner 3, Cathrine M Morberg 1
Abstract
The aim of the present study was to investigate the effect of Bifidobacterium animalis subsp. lactis,
BB-12®, on two primary end points - defecation frequency and gastrointestinal (GI) well-being - in
healthy adults with low defecation frequency and abdominal discomfort. A total of 1248 subjects
were included in a randomised, double-blind, placebo-controlled trial. After a 2-week run-in period,
subjects were randomised to 1 or 10 billion colony-forming units/d of the probiotic strain BB-12® or a
matching placebo capsule once daily for 4 weeks. Subjects completed a diary on bowel habits, relief
of abdominal discomfort and symptoms. GI well-being, defined as global relief of abdominal
discomfort, did not show significant differences. The OR for having a defecation frequency above
baseline for ≥50% of the time was 1·31 (95% CI 0·98, 1·75), P=0·071, for probiotic treatment
overall. Tightening the criteria for being a responder to an increase of ≥1 d/week for ≥50 % of the
time resulted in an OR of 1·55 (95% CI 1·22, 1·96), P=0·0003, for treatment overall. A treatment
effect on average defecation frequency was found (P=0·0065), with the frequency being significantly
higher compared with placebo at all weeks for probiotic treatment overall (all P<0·05). Effects on
defecation frequency were similar for the two doses tested, suggesting that a ceiling effect was
reached with the one billion dose. Overall, 4 weeks' supplementation with the probiotic strain BB-
12® resulted in a clinically relevant benefit on defecation frequency. The results suggest that
consumption of BB-12® improves the GI health of individuals whose symptoms are not sufficiently
severe to consult a doctor (ISRCTN18128385).

Safety:
BB-12® is safe for human consumption and has been granted QPS18 (Qualified
Presumption of Safety) status in Europe and been the subject of a
GRAS (Generally Recognized as Safe) notice to the US Food And Drug
Administration.19 It has been tested in clinical studies at level up to at least 100
billion CFU/day (colony forming units), with no adverse events.
The usual dose (orally with meal (but, not hot beverage):
•Infants and children up to 2 years: one bag, once a day.
•Children from 2-12 years: one bag, one to two times a day (eg, morning and evening).
Duration of use:
• Treatment: As long as symptoms persist e.g. diarrhea, flatulence, colic, bowel function disturbance
and other disorders caused by viral and bacterial infections of the gastrointestinal tract (eg rotavirus
infections).
•Prophylaxis/prevention: No serious adverse events have been reported in vulnerable populations,
such as preterm and full-term infants, pregnant and lactating women and hospitalized patients. In these
populations, B. lactis BB-12@ has been consumed in daily dosages ranging from approximately 0.1 to
100 billion colony forming units (cfu). Supplementation periods have ranged from 2 weeks to 12
months.. There were no adverse events have been reported in healthy populations as well. In this
population, B. lactis BB-12 has been consumed in daily dosages ranging from 0.1 billion to 50 billion
cfu. Supplementation periods have ranged from 1 week to 7 months.
https://www.fda.gov/media/134330/download.
Overdose: No cases of overdose have been reported.

Bifidobacterium animalis subsp. Lactis (BB-12®) is a probiotic strain that has been
around for over 30 years.1
It is the world’s most documented probiotic Bifidobacterium and is backed by more
than 130 publications of clinical studies in humans.2
Reference:
Chr. Hansen website, 2020, accessed 22 Jan 2020.
https://www.chr-hansen.com/en/probiotic-supplements-and-infant-formula/cards/product-cards/bifidobacterium-animalis-subsp-lactis-bb-12
Jungersen M, et al. The Science behind the Probiotic Strain Bifidobacterium animalis subsp. lactis BB-12®. Microorganisms.
2014 Jun;2(2):92-110

Bifidobacterium, BB-12®.pdf

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Bifidobacterium, BB-12®.pdf