B. lactis LAFTI B94 DOCUMENTED PROBIOTIC STRAIN. DEDICATED TO HEARTY KIDS. B. lactis. Health claims. References. White paper

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1 White paper Health claims Natural and Non-prescription Health Products Directorate (NNHPD), the regulatory agency for natural health products in Canada, has approved health claims for, such as: Helps support intestinal/gastrointestinal health (ages months and older) Could promote a favorable gut flora (ages months and older) Participates in a healthy microflora balance (ages months and older) Helps to relieve abdominal discomfort, such as bloating and constipation (ages years and above) Helps children and adolescents with bloating and constipation in irritable bowel syndrome (IBS) (ages years and above) Available in various dosage forms: - Powders or orodispersible powders - Sticks or sachets - Capsules or sprinkle caps - Chewable tablets Basturk A. et al., 1. Efficacy of synbiotic, probiotic, and prebiotic treatments for irritable bowel syndrome in children: A randomized controlled trial. Turk J Gastroenterol. 1; : Borowitz SM, Cox DJ, Kovatchev B, Ritterband LM, Sheen J, Sutphen J. Treatment of childhood constipation by primary care physicians: efficacy and predictors of outcome. Pediatrics. Apr;11():83-. Braegger C, Chmielewska A, Decsi T, et al. Supplementation of infant formula with probiotics and/or prebiotics: A systematic review and comment by the ESPGHAN committee on nutrition. J Pediatr Gastroenterol Nutr 11; : 38-. Crittenden R. et al.,. Probiotic research in Australia, New Zealand and the Asia-Pacific region. Current Pharmaceutical Design. 11, 3-3. Crittenden RG et al. Selection of a bifidobacterium strain to complement resistant starch in a synbiotic yoghurt. Journal of Applied. Microbiology 9 (1) : 8-8. Dilli et al., 13, Treatment outcomes of infants with Cyanotic Congenital Heart Disease treated with symbiotics, Pediatrics, 31-. Dilli et al., 1, The ProPre-save study: effects of probiotics and prebiotics alone or combined on Nectrotizing enterocolitis in very low birth weight infants, The Journal of Pediatrics 1. Erdogan et al., 1, The comparition of the efficacy of two different probiotics in rotavirus gastroenteritis in children, Journal of Tropical Medicine, Volume 1, Article ID 8. Gibson G. R. et al., 1. The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 1.. Işlek et al., 1, The role of Bifidobacterium lactis B9 plus inulin in the treatment of acute infectious diarrhea in children, Turk J Gastroenterol 1; : Koletzko S, Osterrieder S. Acute infectious diarrhea in children. Dtsch Arzetbl Int 9; 1: Mahoney M, Henriksson A. The effect of processed meat and meat starter cultures on gastrointestinal colonization and virulence of Listeria monocytogenes in mice. International Journal of Food Microbiology 8 (3) 1. Osemene (1) Irritable Bowel Syndrome in Children and Adolescents, US Pharmacist ():-. Pang G.. A comparative study of probiotic bacterial strains in vitro and in vivo. School of Biomedical Sciences, University of Newcastle,NSW (Internal Report). Peran L. et al.. A comparative study of the preventative effects exerted by three probiotics, Bifidobacterium lactis, Lactobacillus casei and Lactobacillus acidophilus, in the TNBS model of rat colitis. Journal Of Applied Microbiology 13; Sandhu BK, Paul SP. Irritable bowel syndrome in children: pathogenesis, diagnosis and evidence-based treatment. World J Gastroenterol. 1 May 8;():13-3. Su P, Henriksson A, Tandianus JE, Park JH, Foong F, Dunn NW. Detection and quantification of Bifidobacterium lactis in human faecal samples from a consumption trial. FEMS Microbiol Lett. Mar 1;(1): Su P., Henriksson A. and Mitchell H. Prebiotics enhance survival and prolong the retention period of specific probiotic inocula in an in vivo murine model. Journal of Applied Microbiology 13 (): 39. Van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol. Oct;11(1):1-9. Walker CL, Rudan I, Liu L, et al. Global burden of childhood pneumonia and diarrhoea. Lancet 13; ; 381: 1-1. WebMD. Abdominal Pain, Age 11 and Younger - Topic Overview. Zhang L., Su P., Henriksson A., O Rourke J. and Hazel Mitchell. (8 ) Investigation of the Immunomodulatory Effects of Lactobacillus casei and Bifidobacterium lactis on Helicobacter pylori Infection. Blackwell Publishing Ltd, Helicobacter 13: FOR MORE INFORMATION, PLEASE CONTACT: healthsolutions@lallemand.com or This is business-to-business information not intended for the health professional and final consumer communications. It is based on our own research and development work and is, to the best of our knowledge, reliable. However, Lallemand does not assume any liability resulting from the use of its products, as conditions of use are beyond our control. The information provided should not be used as a substitute for any form of advice and in all cases, local marketers and distributors should check local regulatory requirements before use as different claims may be approved depending on the regulations applicable in each country. Lallemand does not assume any liability resulting from the claims made by its customers on their packaging or promotional material. PRO shutterstock - Graphic design: laurencebonhomme.com References DOCUMENTED PROBIOTIC STRAIN. DEDICATED TO HEARTY KIDS.

2 A first-class probiotic strain FOR HEARTY KIDS AND TEENS AND INULIN, THE SYNBIOTIC EFFECT KEY PROBIOTIC FEATURES Survival through the digestive tract: in vitro human stomach model shows survival within the stomach environment and physiological concentration of bile [Crittenden, 1]. This was further confirmed by a study in adult volunteers. Four weeks after the feeding stopped, could still be detected in one subject [Su, ] (Fig. 1). Competition with other microorganisms such as Helicobacter pylori, Salmonella typhimurium or Listeria monocytogenes (demonstrated in animal models) [Zhang, 8; Crittenden, ; Mahoney, 3]. Support of natural defenses, in both in vitro and in vivo models of immune challenges: has been shown to reduce the production of TNF-α, inos and COX- [Peran, ], increase the level of Interleukin 1 and decrease the eosinophils level [Pang, ]. The probiotic strain Bifidobacterium lactis has been specifically documented in the area of gut health. It benefits from a strong body of clinical evidence in children and adolescents, supported by in vitro and in vivo documentation of its modes of action. A CONVERGING BODY OF CLINICAL EVIDENCE Gut transit in children & teens Gut health in infants & children 1 clinical study on occasional constipation in children and teenagers [Basturk, 1] clinical studies on occasional diarrhea in infants and children [Erdogan, 1], [Islek, 1] FOR OTHER USE THAN FOOD/DIETARY SUPPLEMENT clinical studies in premature infants at risk for Necrotizing Enterocolitis (NEC) [Dilli, 13], [Dilli, 1] has been selected and fully documented for its probiotic features in in vitro and in vivo testing: Log 1 CFU/g wet weight 1., Figure 1: Gastrointestinal tract survival of in consumption trial faecal samples Subject 1 Subject Subject 3 Subject Subject Feeding period (day 1-), washout period (day 8-3) Prebiotics are defined as a substrate that is selectively utilized by host microorganisms conferring a health benefit [Gibson, 1], in other words a food for probiotic. Most commonly used natural prebiotics are: inulin, fructooligosaccharides (FOS) or galacto-oligosaccharides (GOS). Their overall benefits could include normal bowel function and management of occasional constipation. The effects of prebiotics have been extensively investigated in infant nutrition studies. In particular, it has been shown that stool properties of infants receiving prebiotics are similar to those of breastfed infants [Braegger, 11]. In an in vitro study, was first selected among Bifidobacterium isolates for its capacity to hydrolyze resistant starch, grow on various prebiotic substrates and resist to acidic and proteaserich environment of stomach and physiological concentration of bile. A selection of prebiotics was then screened for their potential synergy with. Most of them showed positive effect on the growth of in vitro (inulin, FOS, GOS, isomalto-oligosaccharides, xylo-oligosaccharides, and soybean-oligosaccharides) [Crittenden, 1]. Prebiotics were further tested in vivo (mice model) [Su, ], indicating that FOS and inulin were the best candidates to increase the survival and retention time of the probiotic in the gut, compared to control (glucose). Both extended the retention time of from 3 to around 1 days (fig. ). Based on these data, inulin has been used in the formulation of children specific synbiotic formula in association with (x1 9 CFU and 9 mg inulin per sachet). Most of the randomized trials presented use this formulation. Inulin is a long-chain fructo-oligosaccharide (FOS) obtained from chicory extract. Its consumption has been linked to increased levels of bifidobacteria and lactobacilli in the intestinal flora. Log 1 CFU/g wet weight Figure : Detection of in faecal samples from mice 1 1 Time (h) FOS Inulin SOS Glucose Further to its selection, the strain was fully identified by genetic methods and its genome sequenced. 3

3 Kids & teens DIGESTIVE COMFORT Gut health is a common concern in children and adolescents. Gut discomfort, such as occasional bloating, irregular transit and constipation, is very frequent in young populations and often represents a reason to visit the doctor. About 1 out of 3 children is seen by a doctor for abdominal discomfort by the time they are aged 1, however the majority has no serious health problems [WebMD]. SIGNIFICANTLY IMPROVES BLOATING, BELCHING ABDOMINAL FULLNESS AND OCCASIONAL CONSTIPATION IN CHILDREN AND TEENS [BASTURK, 1] GUT DISCOMFORT IN CHILDREN AND TEENAGERS 1 children and adolescents, aged -1 years old, were enrolled in a randomized, double-blind, controlled study [Basturk, 1]. They were randomized between 3 groups: PREBIOTIC: the children received 9 mg of inulin/ day for weeks. PROBIOTIC: the children received x1 9 CFU /day for weeks. SYNBIOTIC: the children received 9 mg of inulin + x1 9 CFU /day for weeks. Figure 3: (with or without inulin) and occasional gut discomfort Occasional constipation has been described as the most common gut disturbance in young children, with reported prevalence between 1% and 3% [Van Den Berg, ]. It is the major reason for 3% of visits to pediatric gastroenterologists [Borowitz, ]. Most cases are temporary, and can often be linked to behavioral causes (early toilet training in the youngest) or dietary changes. Children and teens experiencing overall occasional abdominal discomfort in % [Osemene, 1] % of participants before and after 1 month of probiotic or synbiotic intake PROBIOTIC group Before After 1 month Overall occasional abdominal discomfort concerns 8% to 1% of children and 13% to 38% of adolescents, with higher prevalence in girls [Osemene, 1]. Gut disturbances may be associated with a brain-gut axis disorder. It is linked with occasional discomfort in daily life, with possible impact on feeling healthy, sleeping behavior, stress and overall quality of life. It can impact school attendance and success, which in turns generates still more stress. Kids Kids 8% to 1% 13% to 38% At the end of the -week period, the following parameters were monitored for all children: postprandial swelling, belching-abdominal distension, mucoid defecation, difficulty in defecation, feeling of incomplete defecation, urgent defecation. Bloating after meals Belching-abdominal fullness Difficulty with defecation * * * p<.1 * p=.1.8.8* * p=.31 8 A MATTER OF BALANCE Most of gut health issues can be linked to stress factors for the gut microbiota - dietary changes, stress, antibiotic, poor diet balance etc. - which can affect its composition and balance. In children, the gut microbiota and immune systems are still maturing. The role of probiotics in preserving and restoring the gut microbiota and reinforcing the body natural defenses is well documented. With their track record of safety, biological image and lack of side-effects, probiotics are particularly well suited for children s gut health management. Teens In summary, the results of the study showed that alone significantly improved symptoms of gut discomfort (fig. 3): bloating after meals (p=.1), belching abdominal fullness (p<.1) and constipation (p=.31). In addition, the synbiotic supplement also improved a fourth symptom: the presence of mucus in the feces (p=.1) (fig. 3). Altogether, the synbiotic group showed recovery from all measured primary parameters of the study in 39.1% of patients and the probiotic alone in 9.%. There was a significant difference between the prebiotic and synbiotic groups. No side effects (diarrhea, constipation, abdominal pain) were observed in any children. Bloating after meals Belching-abdominal fullness Difficulty with defecation Mucus in stool SYNBIOTIC group 13* 1.* * p <.1 1.* 3.* * p =.1 * p =.1 * p =... Before After 1 month. 9. 8

4 Gut health IN INFANTS & CHILDREN Occasional diarrhea of various origins is particularly frequent in young children. Worldwide, 1 to 1. million children are affected every year. 8% of them are under two years of age and most are -11 month-old infants. Children under the age of five experience occasional diarrhea 3 to times per year, and very few (1%-3%) of these cases are serious [Koletzko, 9; Walker, 13]. FOR OTHER USE THAN FOOD/DIETARY SUPPLEMENT In neonates, more critical gut disorders such as necrotizing enterocolitis (NEC) can appear. It may result from an inappropriate immunologic response to intestinal bacteria and a disruption in the balance of the gastrointestinal microbiota in susceptible individuals. Two randomized controlled trials have been performed in infants at risk for NEC*. with inulin decreases the risk of either nosocomial infections [Dilli, 13 - study conducted on 1 hospitalized neonates], or NEC [Dilli, 1 - study conducted on hospitalized infants with very low birth weight] in those at-risk populations. & DURATION OF OCCASIONAL DIARRHEA [Erdogan, 1] Figure : Duration time (days) of occasional diarrhea *p<.1 * Such studies in hospitalized infants are to be taken with caution. In these conditions, probiotics must be considered as pharmaceuticals and used under medical supervision. However, the studies serve as a real proof of concept about the benefits of for gut health in young populations. 8 A randomized, placebo controlled trial was conducted in children aged months to years, with occasional diarrhea [Erdogan, 1]. The probiotic was supplemented daily at x1 9 CFU in combination with oral rehydration therapy and rapid refeeding with a normal diet. significantly reduced the duration of occasional diarrhea by approximately 3 days vs placebo (p<.1) (fig. ). Days Control.1 + INULIN & DURATION OF OCCASIONAL DIARRHEA [Islek, 1] Figure : Duration time (days) of occasional diarrhea Another randomized, placebo controlled trial involved 1 children with occasional diarrhea, aged months to years [Islek, 1]. They received either placebo or synbiotic supplement containing x1 9 CFU and 9 mg inulin, once a day for days, in addition to normal fluid therapy and nutritional support. The synbiotic significantly reduced the duration of occasional diarrhea by 31 hours on average vs placebo (p<.1) (fig. ). Moreover, it appears that the synbiotic was more effective when taken within the first hours of diarrhea (p=.). Days. Control *p<.1-31h inulin

5 White paper Health claims Natural and Non-prescription Health Products Directorate (NNHPD), the regulatory agency for natural health products in Canada, has approved health claims for, such as: Helps support intestinal/gastrointestinal health (ages months and older) Could promote a favorable gut flora (ages months and older) Participates in a healthy microflora balance (ages months and older) Helps to relieve abdominal discomfort, such as bloating and constipation (ages years and above) Helps children and adolescents with bloating and constipation in irritable bowel syndrome (IBS) (ages years and above) Available in various dosage forms: - Powders or orodispersible powders - Sticks or sachets - Capsules or sprinkle caps - Chewable tablets Basturk A. et al., 1. Efficacy of synbiotic, probiotic, and prebiotic treatments for irritable bowel syndrome in children: A randomized controlled trial. Turk J Gastroenterol. 1; : Borowitz SM, Cox DJ, Kovatchev B, Ritterband LM, Sheen J, Sutphen J. Treatment of childhood constipation by primary care physicians: efficacy and predictors of outcome. Pediatrics. Apr;11():83-. Braegger C, Chmielewska A, Decsi T, et al. Supplementation of infant formula with probiotics and/or prebiotics: A systematic review and comment by the ESPGHAN committee on nutrition. J Pediatr Gastroenterol Nutr 11; : 38-. Crittenden R. et al.,. Probiotic research in Australia, New Zealand and the Asia-Pacific region. Current Pharmaceutical Design. 11, 3-3. Crittenden RG et al. Selection of a bifidobacterium strain to complement resistant starch in a synbiotic yoghurt. Journal of Applied. Microbiology 9 (1) : 8-8. Dilli et al., 13, Treatment outcomes of infants with Cyanotic Congenital Heart Disease treated with symbiotics, Pediatrics, 31-. Dilli et al., 1, The ProPre-save study: effects of probiotics and prebiotics alone or combined on Nectrotizing enterocolitis in very low birth weight infants, The Journal of Pediatrics 1. Erdogan et al., 1, The comparition of the efficacy of two different probiotics in rotavirus gastroenteritis in children, Journal of Tropical Medicine, Volume 1, Article ID 8. Gibson G. R. et al., 1. The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 1.. Işlek et al., 1, The role of Bifidobacterium lactis B9 plus inulin in the treatment of acute infectious diarrhea in children, Turk J Gastroenterol 1; : Koletzko S, Osterrieder S. Acute infectious diarrhea in children. Dtsch Arzetbl Int 9; 1: Mahoney M, Henriksson A. The effect of processed meat and meat starter cultures on gastrointestinal colonization and virulence of Listeria monocytogenes in mice. International Journal of Food Microbiology 8 (3) 1. Osemene (1) Irritable Bowel Syndrome in Children and Adolescents, US Pharmacist ():-. Pang G.. A comparative study of probiotic bacterial strains in vitro and in vivo. School of Biomedical Sciences, University of Newcastle,NSW (Internal Report). Peran L. et al.. A comparative study of the preventative effects exerted by three probiotics, Bifidobacterium lactis, Lactobacillus casei and Lactobacillus acidophilus, in the TNBS model of rat colitis. Journal Of Applied Microbiology 13; Sandhu BK, Paul SP. Irritable bowel syndrome in children: pathogenesis, diagnosis and evidence-based treatment. World J Gastroenterol. 1 May 8;():13-3. Su P, Henriksson A, Tandianus JE, Park JH, Foong F, Dunn NW. Detection and quantification of Bifidobacterium lactis in human faecal samples from a consumption trial. FEMS Microbiol Lett. Mar 1;(1): Su P., Henriksson A. and Mitchell H. Prebiotics enhance survival and prolong the retention period of specific probiotic inocula in an in vivo murine model. Journal of Applied Microbiology 13 (): 39. Van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol. Oct;11(1):1-9. Walker CL, Rudan I, Liu L, et al. Global burden of childhood pneumonia and diarrhoea. Lancet 13; ; 381: 1-1. WebMD. Abdominal Pain, Age 11 and Younger - Topic Overview. Zhang L., Su P., Henriksson A., O Rourke J. and Hazel Mitchell. (8 ) Investigation of the Immunomodulatory Effects of Lactobacillus casei and Bifidobacterium lactis on Helicobacter pylori Infection. Blackwell Publishing Ltd, Helicobacter 13: FOR MORE INFORMATION, PLEASE CONTACT: healthsolutions@lallemand.com or This is business-to-business information not intended for the health professional and final consumer communications. It is based on our own research and development work and is, to the best of our knowledge, reliable. However, Lallemand does not assume any liability resulting from the use of its products, as conditions of use are beyond our control. The information provided should not be used as a substitute for any form of advice and in all cases, local marketers and distributors should check local regulatory requirements before use as different claims may be approved depending on the regulations applicable in each country. Lallemand does not assume any liability resulting from the claims made by its customers on their packaging or promotional material. PRO shutterstock - Graphic design: laurencebonhomme.com References DOCUMENTED PROBIOTIC STRAIN. DEDICATED TO HEARTY KIDS.