HN019 is a strain from the Bifidobacterium lactis species of bacteria. It is sometimes referred to as Bifidobacterium lactis DR10TM.The Bifidobacterium lactis species of bacteria has recently been reclassified as B. animalis subsp. lactis; however, for ease of reference, it is typically known as Bifidobacterium lactis (Masco et al, 2004). The whole Bifidobacteria genus is extremely well-researched and is considered to be very safe for human consumption (Borriello et al, 2003), and is listed in the Inventory of Microorganisms with Documented History of Use in Human Food (Mogenson et al, 2002). This genera of bacteria is naturally present in foods, particularly dairy products, and in fact, the Bifidobacterium lactis HN019 strain was originally isolated from a yogurt source.
Bifidobacterium lactis HN019 – Safety and Survival
Bifidobacterium lactis HN019 is a food supplement with research demonstrating its safety and survival to reach the gut alive. A recent study in 2018 by Ibarra, A. et al., concluded B. lactis HN019 to be safe and well tolerated. This was also confirmed in an additional study by Dekker, J.W. et al., in 2009 where the strain was given to newborns. No statistical differences were noted between the placebo and probiotic group in terms of adverse events, as such the authors concluded the strain to be safe.
Bifidobacterium lactis HN019 has been detected in stools suggesting successful passage through the digestive system. This was shown in studies by Oswari, H. et al., (2013) and Prasad, J. et al., (2013) where for all participants taking B. lactis HN019 it was isolated in faecal samples compared to no participants in the control group.
Bifidobacterium lactis HN019 and Intestinal Health
The ability to survive transit through the stomach environment and to help stabilise the population and activity of the intestinal microbiota are both considered to be the primary characteristics of a probiotic. In vitro studies have shown B. lactis HN019 to be capable of surviving the transit through the intestinal tract and adhesion to the intestinal mucosa; however, it is clinical evidence which can demonstrate this ability more definitively. B. lactis HN019 has been researched for its potential to help improve intestinal health; in particular, there are two dietary intervention studies which suggested that consumption of B. lactis HN019 had a favourable modulatory effect on the gut microbiota.
The first of these was a 2003 randomised, double-blind, placebo-controlled study which monitored 30 participants aged between 20-60 years. The subjects were randomly divided into 3 groups: those in the first group were given a milk drink containing 2.4g of galacto-oligosccharides (GOS) per day, those in the second group were given a similar milk drink containing 30 billion CFU of B. lactis HN019 per day, and those in the third group were given a placebo of plain milk. After a 2 week pre-intervention period the trial was conducted over a four week period, followed by a two week wash out period. Faecal samples were collected from each of the participants every week and their microbiota analysed. The results indicated that the probiotic group showed a significant increase in levels of both Lactobacilli bacteria as well as Bifidobacteria, suggesting that the probiotic helped to globally stimulate the growth of beneficial bacteria in the gut and not just those from the probiotic species used in the trial. The GOS group showed similar increases in these friendly microbes, but the placebo group showed no change in their gut microbiota composition. This evidence indicates that supplementing with either prebiotics or probiotics could offer this beneficial effect, and offers hope for those who are sensitive to prebiotics, who could potentially still experience an improvement in their intestinal health by taking Bifidobacterium lactis HN019 alone (Gopal et al, 2003).
Bifidobacterium lactis HN019 and IBS
Poor intestinal health can manifest as a broad range of non-specific functional gastrointestinal symptoms, typically of unknown origin as medical tests fail to reveal a specific cause. Medical practitioners often label these symptoms under the umbrella term of Irritable Bowel Syndrome (IBS). Due to a lack of viable medical solutions to alleviate symptoms, an increasing amount of research is being focused on the potential for probiotics to help alleviate these increasingly common symptoms. In one such study (Waller et al, 2011) the effects of B. lactis HN019 on whole gut transit time (WGTT), as well as the frequency of functional gastrointestinal symptoms in adults, were assessed. A total of 88 people participated in this randomised placebo controlled trial, in which the participants were divided into 3 groups: the first group was given a high dose (17.5 billion CFUs) of B. lactis HN019, the second group was given a lower dose (1.8 billion CFUs) of B. lactis HN019, and the third group was given a placebo. Improvements in both WGTT and functional gastrointestinal symptoms were observed in both of the probiotic groups: the higher dose appeared to offer the most notable impact with 8/9 of the gastrointestinal symptoms improving, though even the lower dose probiotic appeared to result in a significant improvement with 7/9 symptoms improving, these results compared to a 2/9 improvement in the placebo group. These impressive scores indicate that the B. lactis HN019 strain is significant for improving overall gut health.
WGTT is an important factor to consider when looking at overall gut health; slow WGTT can also be associated with other complications such as gallstones and small intestinal overgrowth (SIBO). In this study where the effects of probiotics on WGTT were assessed, the participants ingested radiopaque markers and underwent x-rays to identify the speed of transit when taking B. lactis HN019. The results indicated that those people who originally began the trial with a slow WGTT experienced big improvements in their transit time, with the results being most significant in the group taking the higher dose. However, in those people displaying a normal WGTT at the onset of the study, the probiotic group did not experience any significant digestive changes. This suggests that the probiotic may normalise bowel function in those participants who were previously experiencing digestive problems, therefore we may conclude that taking B. lactis HN019 stabilises and balances the gut bacteria improving overall gut health (Waller, PA. et al, 2011).
In a different study, the effects of a probiotic combination, Lactobacillus acidophilus NCFM and Bifidobacterium lactis HN019, on stool transit time in patients with pre-existing constipation were monitored. For the purposes of the study, 47 participants were divided into two groups, one receiving a combination of a prebiotic (polydextrose) and the probiotic combination in a yogurt and the other a placebo group who were just given plain yogurt. Results showed that, after the 2 week intervention period, the treatment group had significantly shorter transit time compared to baseline than the control group, but would not cause faster transit time or diarrhoea in those with normal bowel function (Magro et al., 2014).
Miller et al (2016) conducted a meta-analysis to determine the efficacy of short term probiotic supplementation on intestinal transit time (ITT) in adults. 15 randomised, controlled trials, including 675 participants were reviewed. Medium to large treatment effects were identified with B. lactis HN019 (SMD: 0.67, P < 0.001) and B. lactis DN-173 010 (SMD: 0.54, P < 0.01) while other probiotic strains yielded negligible reductions in ITT relative to control.The authors concluded that probiotic supplementation is moderately efficacious for reducing ITT in adults. Probiotics were most efficacious in constipated subjects, when evaluated in high-quality studies, and with certain probiotic strains (especially B. lactis HN019).
Other related studies: Hemalatha R. et al., (2014)
Also relevant: Show all strains in the database researched for Constipation and IBS
Bifidobacterium lactis HN019 and Modulation of the Immune System
It is not always an obvious connection for many people to make, but due to the fact that around 70% of our immune cells are located in the intestines, the potential for our gut microbiome to affect our immune function is being widely explored. Emerging evidence indicates that our resident bacteria do interact with and influence the activity of our immune cells, which include phagocytic cells (monocytes, macrophages, neutrophils) which are effective microbial pathogen eliminators, and natural killer cells which are vital for combatting viral infections and tumour cells. These are often used as ‘markers’ in immunity and are therefore used to assess the efficacy of an intervention to raise immunity.
A double blind, three stage ‘before, during, and after’ clinical trial was conducted to look at how this particular strain, Bifidobacterium lactis HN019, might enhance immune function. Fifty healthy Taiwanese citizens aged between 41-81 years of age were invited to take part in the study, and randomly assigned into two groups labelled A and B. In the preliminary stage, both groups simply received a plain low-fat milk drink for 3 weeks. In stage 2, those in group A were given a low-fat milk drink (LFMD) containing the probiotic Bifidobacterium lactis HN019, and those in group B were given the same probiotic in a lactose-hydrolysed LFDM, both for a period of 3 weeks. During the third stage of the study, both groups were put back onto a plain LFMD for a further 3 weeks.
The results indicated that consumption of the plain LFMD had no effect on immune responses, but, during stage 2, significant improvements in immune responses were noted, with both phagocytosis by the PMN (Polymorphonuclear) cells and NK cell tumour killing activity being enhanced following consumption of B. lactis HN019. It’s worth noting that those who consumed the B. lactis HN019 in lactose-hydrolysed LFMD were found to have the greatest increase in NK cell tumour killing activity. Oligosaccharides are produced when lactose is hydrolysed and as these act as a food source, or prebiotic, for the live cultures, this may account for the increased activity and enhanced results in the group taking the lactose-hydrolysed LFMD.
The enhanced immune responses observed in participants during stage 2 appeared to level off once they stopped consuming the probiotic milk; however, the plateaued responses were still an improvement on those recorded in the pre-treatment phase, suggesting immune enhancement by B. lactis HN019 had a sustained effect even after supplementation ceased. The authors concluded that the strain Bifidobacterium lactis HN019 enhanced immune function of two different types of leucocytes (Chiang, BL. 2000).
Another randomised, double-blind, placebo-controlled trial involving 25 healthy, elderly participants also looked at the effects of Bifidobacterium lactis HN019 on immunity. In this trial, the participants were divided into two groups: those in the first group were given 180ml of low-fat, low-lactose milk, twice a day for a period of 6 weeks, whereas those in the other group were given the same milk drink fortified with 150 billion CFUs of Bifidobacterium lactis HN019, for the same length of time. Immunity markers including phagocytic capacity were monitored via blood tests at 0, 3, 6 and 12 weeks post trial commencement.
The results showed that, compared to the placebo group, those consuming the probiotic produced significantly enhanced levels of in****eron-alpha, upon stimulation of their peripheral blood mononuclear cells in culture, and also displayed significant increases in polymorphonuclear cell phagocytic capacity. These results demonstrated that consumption of Bifidobacterium lactis HN019 improved natural immunity in these elderly subjects in a relatively short time (6 weeks) (Arunachalam, K., 2000).
In another clinical trial to measure the effects of this probiotic strain on immune function, 30 healthy, elderly volunteers were engaged in a 3 stage dietary supplementation programme, beginning with a non-treatment run-in period, then a treatment period where participants were given either 5 billion or 50 billion CFUs of the probiotic Bifidobacterium lactis HN019 for 3 weeks, followed by a wash out period for 3 weeks. Increases in immune markers of T lymphocytes and natural killer cells were measured in blood tests. Immune markers were significantly raised in those that had taken the probiotic, and the dose of the probiotic didn’t appear to be significant. Interestingly, the most notable improvements in immune function were seen in those subjects who displayed poor immune responses pre-treatment (Gill H.S. et al, 2001).
As it’s been noted that gut physiology can alter and deteriorate with age, rendering the elderly more susceptible to gut-related illnesses, researchers tried to determine whether the probiotic strain Bifidobacterium lactis HN019 could enhance health indices in the elderly. In order to demonstrate this effect, a randomised, double-blind, placebo-controlled study was carried out using four groups each comprised of 20 elderly participants. Each of the volunteers were given 250ml of reconstituted milk, either as a plain milk drink in the placebo group, or in the 3 probiotic groups as a milk drink fortified with different doses of the probiotic Bifidobacterium lactis HN019: 5 billion CFU/day (high), 1 billion CFU/day (medium), or 65 million CFU/day (low). The entire study lasted 8 weeks with an intervention period of 4 weeks.
The study showed that, compared to the placebo group, intervention with Bifodobacterium lactis HN019 significantly increased the overall intestinal counts of Bifidobacteria, Lactobacilli and Enterococci, in participants of the probiotic groups, and reduced the numbers of Enterobacteria present. Enterobacteriaceae are a large family of Gram-negative bacteria that includes many of the most common pathogens such as Salmonella and Escherica coli. The results suggested that this positive effect was not dependent on the dose, and that even the lower dose of the probiotic gave desirable changes in the intestinal microflora of the elderly (Ahmed et al., 2007).
Elderly people have an increased vulnerability to infections which is often associated with a degeneration in cellular immune function. A systematic review and meta-analysis was conducted (Miller et al, 2017) to ascertain the efficacy of the probiotic B. lactis HN019 on cellular immune function in the elderly. This review included controlled studies which looked at polymorphonuclear (PMN) cell phagocytic activity or natural killer (NK) cell activity following consumption of B. lactis HN019. Four clinical trials were selected with intervention periods of 3-6 weeks, using doses of between 5-300 billion CFU of the probiotic.
Although the number of subjects in the trials was modest, all consistently found that daily short-term consumption of probiotic B. lactis HN019 was highly efficacious in enhancing PMN phagocytic capacity and moderately effective at enhancing NK cell tumoricidal activity in healthy elderly adults. However, the correlation between B. lactis HN019 mediated PMN and NK cell activity improvement and resistance to infection and diseases was not studied in this review.
Further related studies: Gill, H.S. et al (20012). Gill HS et al., (20013), Liu C et al (2010), Sazawal et al, (2004)
Growing evidence suggests that a healthy gut microbiota is associated with good health in children.
Therefore, various probiotics are being trialled in children, to see which strains offer the most benefits for children’s health. Bifodobacterium lactis HN019 is one of the probiotic strains selected for further exploration, and evidence does seem to support its potential for use in the support of children’s health.
A trial which was conducted in order to look at the effects of probiotics on iron status, anaemia and growth in children aged between 1-4 years of age. In this community-based, placebo-controlled trial 624 children were enrolled and randomly assigned to two different groups. In the first group, the children received a milk fortified with the probiotic strain Bifidobacterium lactis HN019 at a strength of 19 million CFUs along with an additional prebiotic (2.4 g/day of prebiotic oligosaccharides milk), whereas the children in the second group received a placebo drink. The trial lasted for a period of one year, during which blood tests were conducted along with weight and height measurements taken at the baseline, mid study and at the end of the study. Results indicated that, compared to the placebo group, those children who had consumed the probiotic and prebiotic fortified milk for the duration of the study period were 45% less likely to experience anaemia and iron deficiency. The children in the probiotic group also increased weight gain by 0.13kg/year (Sazawal S., 2010 (1)).
An additional study was conducted in India on a group of 379 healthy children to see if probiotics could reduce the incidence of diarrhoea in infants aged between 2-5 years. Diarrhoea is a major cause of mortality among children under five years old, and is considered to be a significant public health issue in India. Three randomly allocated groups of children received one of two probiotics, either Lactobacillus paracasei Lpc-37 or Bifidobacterium lactis HN019, each at a dose of 2.5 billion CFUs per day, or a placebo, for a period of 9 months. They were assessed for weight gain, growth and occurrence of diarrhoea and fever symptoms. The results were interesting in that neither of the tested probiotics; L. paracasei Lpc-37 or Bifidobacterium lactis HN019 had any influence on weight gain or linear growth and there was no significant effect of the probiotics on the incidence of diarrhoea and fever when looking at the whole trial period. However, during the wet season, in the months of August and September, the occurrence of diarrhoea was statistically significantly higher in placebo group (16.9%) compared to L. paracasei Lpc- 37 (11.7 %) and B.lactis HN019 groups (8.4 %). A similar difference was seen in the incidence of fever with the placebo group being (11.5%) compared to the L. paracasei Lpc-37 group (7%) and B. lactis HN019 group (7.3%). (Hemalatha R. et al., 2014).
The safety of probiotics for use in infants, and also in pregnant and nursing women, is an area of particular interest for scientists and medical professionals, as it is essential that any suggested interventions pose no risk to the child. The following double-blind placebo-controlled clinical trial demonstrated the safety of two commercially available probiotic strains: Lactobacillus rhamnosus HN001 and Bifidobacterium lactis HN019. The focus of the trial was to determine whether the probiotics would help to reduce the risk of infant eczema. To try and demonstrate this effect, three groups of infants received daily doses of either Lactobacillus rhamnosus HN001 6 billion CFU/day, Bifidobacterium lactis HN019 9 billion CFU/ day, or a placebo. The period of supplementation took place from birth to 24 months. The children’s mothers also received these probiotics, from 35 weeks gestation and then for up to 6 months postnatally whilst breastfeeding. Several safety outcomes were measured and it was concluded that these particular probiotic strains were safe and well tolerated in infants (Dekka et al., 2009).
Further related studies: Morgan AR, et al (2014), Oswari H et al (2013), Prescott SL (2008), Sazawal et al (2010(1)), Sazawal et al, (2004), Sazawal et al (2010(2)), Wickens K, et al. (2008). Wickens K, et al. (2012),
Bifidobacterium lactis HN019 and Metabolic Disorders
Metabolic disorders are a growing health concern. They may manifest as a variety of different health conditions including obesity, diabetes and thyroid dysfunction. These disorders are often inherited, though can respond well to dietary and lifestyle changes. Symptoms are typically a large waist circumference, elevated blood sugar/blood pressure/cholesterol levels, increased thirst and urination, fatigue, and blurred vision. Individuals are considered to have metabolic syndrome (MetS) when they display at least three of the classic symptoms, and there is an increased risk of cardiovascular problems in affected individuals. Probiotics are one of the natural interventions which are being studied to assess their potential to support such conditions.
To explore this potential, a placebo controlled trial was conducted to assess the effects of Bifidobacterium lactis HN019 on the classic symptoms of MetS and other related cardiovascular risk factors. For the purposes of the study, 51 participants were divided into two groups: one group was given 80 mL fermented milk 272 billion CFUs of B. lactis HN019 for 45 days, and the other group was given a placebo. The results were statistically significant as they showed a significant reduction in body mass index, total cholesterol and low density lipoprotein compared to baseline and control groups. In addition to this the results showed a decrease in tumour necrosis factor and interleukin -6. Showing a potential for this strain to help reduce obesity, blood lipids and some inflammatory markers in those patients with MetS and CVD risk (Bernini et al., 2006).
Ahmed M. et al., (2007) Impact of consumption of different levels of Bifidobacterium lactis HN019 on the intestinal microflora of elderly human subjects. J Nutr. 11: 26-31. Arunachalam K, Gill H.S., & Chandra R.K., (2000). ’Enhancement of natural immune function by dietary consumption of Bifidobacterium lactis (HN019)’. Eur J Clin Nutr. 54: 263-267. Bernini L.J., et al., (2016). ‘Beneficial effects of Bifidobacterium lactis on lipid profile and cytokines in patients with metabolic syndrome: A randomised trial. Effects of probiotics on metabolic syndrome’. Nutrition 32(6):716-9. Borriello, S.P. et al, (2003). ‘Safety of probiotics that contain lactobacilli or bifidobacteria’. Clin. Infect. Dis. 36:775-780. Chiang B. L, et al. (2000) ‘Enhancing immunity by dietary consumption of a probiotic lactic acid bacterium (Bifidobacterium lactis HN019): optimisation and definition of cellular immune responses’. Eur J Clin Nutr. 54: 849-855. Dekker J.W, (2009) ‘Safety aspects of probiotic bacterial strains Lactobacillus rhamnosus HN001 and Bifidobacterium animalis subsp. lactis HN019 in human infants aged 0–2 years’. Int Dairy J. 19: 149–154. Gill H.S. et al., (2001)1. ‘Enhancement of immunity in the elderly by dietary supplementation with the probiotic Bifidobacterium lactis HN019’. Am J Clin Nutr. 74: 833-839. Gill H.S, et al., (2001)2 ‘Optimizing immunity and gut function in the elderly’. J Nutr Health Aging. 5: 80-91. Gill H.S. et al., (2001)3. ‘Dietary probiotic supplementation enhances natural killer cell activity in the elderly: an investigation of age-related immunological changes’. J Clin Immunol. 21: 264-271. Gopal P. et al (2003). ‘Effects of the consumption of Bifidobacterium lactis HN019 (DR10TM) and galacto-oligosaccharides on the microflora of the gastrointestinal tract in human subjects’. Nutr Res. 23: 1313-1328. 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Clin Exp Allergy. 42: 1071-1079.Information on this strain was gathered by Joanna Scott-Lutyens BA (hons), DipION, Nutritional Therapist; and Kerry Beeson, BSc (Nut.Med) Nutritional Therapist.