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Good Bacteria

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Good Bacteria Good Bacteria

Pandemic worries helped fuel the growth of the probiotics market in several areas.

Ingredient suppliers that focus on probiotics have noted increased interest in their products since the start of the coronavirus pandemic, and that interest is for more than the traditional digestive health uses of their ingredients.

Reshma Rathi, vice president of operations, Specialty Enzymes & Probiotics in Chino, CA, said, “The pandemic has increased awareness and demand for probiotics in the past two years because they are among the dietary supplements shown to promote immune health.

“In fact, we’ve published several clinical trials and case series in 2021 alone in peer-reviewed journals on our powerful synbiotic blend ProbioSEB CSC3, comprised of three spore-forming Bacillus probiotics and a prebiotic. When taken in conjunction with a potent proteolytic enzyme blend ImmunoSEB, it showed promising results.

“The most recent clinical trial assessed the safety and efficacy of a combined treatment of ImmunoSEB and ProbioSEB CSC3 in patients experiencing post-viral fatigue,” she said. “Results showed that 91 percent of patients receiving supplementation of ImmunoSEB and ProbioSEB CSC3 experienced resolution of post-viral fatigue by day 14, versus only 15 percent in the control arm. Patients in the test arm also had a greater improvement in physical and mental fatigue.”

Rathi noted another study showed the combination significantly supported the resolution of symptoms in people hospitalized with mild to moderate COVID-19 versus the test arm on day 10 (93 percent vs. 60 percent).

“These products can be positioned as promoting overall immune health, the resolution of post-viral fatigue, and promoting energy levels,” she said.

Buffy Stahl, technology scouting and open innovation leader with IFF Health (New York), also saw the extra interest for probiotic ingredients. “Unsurprisingly, we found an increased focus on immune health throughout the COVID-19 pandemic. And this trend is still going strong! In fact, in a recent survey, 16,000 U.S. adults declared immune health to be top of mind for 2022, with 46 percent reporting an interest in purchasing immune health products,”1 she said.

She noted, “Probiotic strains such as Bifidobacterium lactis BI-04, found in HOWARU Protect Adult, are a great solution to help healthy adults significantly boost their immune system and maintain overall health. In a recent study, those taking BI-04 over a five-month period had a 27 percent lower risk of recurring URTI (upper respiratory tract infection) episodes compared to placebo group. In fact, according to a recent survey of 250 Board Certified Primary Care Physicians, BI-04 is the No. 1 doctor-preferred probiotic strain for respiratory health.”2

“Not only are consumers seeking to support everyday immune health and wellness—like other categories, they’re also looking for tailored immune support—such as vaginal health immunity support,” Stahl said. “Along those same lines, we’re seeing more consumers focus on prevention. They’re taking daily supplements to boost their immune health, rather than only focusing on it acutely—like reaching for medicine once they already have an infection.3

“And as science develops around the gut microbiota’s impact on various body sites and the impact specific probiotic strains can have on the microbiota and health, consumers are beginning to understand that probiotics offer diverse benefits that help target all of these health concerns—beyond traditional digestive health benefits. They’re now seeking tailored solutions to health concerns such as digestive, stress and weight management.”

Kristin Wilhoyte, global director of product marketing, Deerland Probiotics and Enzymes (now a part of ADM), Georgia, said, as COVID-19 enters a new phase (BA.5, a highly contagious form), its impact on how consumers protect themselves through natural means continues. “According to the new Nutrition Business Journal “Condition Specific Report,” in 2021, the GI (gastrointestinal) health market is back, pegging an increase of 8.7 percent in tandem with renewed interest in probiotics as well as in synbiotics, prebiotics and postbiotics,” she noted. “As consumers understand that their immune health is related to gut health, this is a good sign of opportunities for product development.”

New Ingredient Offerings

New probiotic offerings boost benefits and provide finished product opportunity. Wilhoyte said, “The newest generation of probiotics are spore-formers, which are much hardier than conventional strains, thus allowing for broader consumer-friendly applications.” She explained that Deerland’s Bacillus subtilis DE111 is a leading strain of B. subtilis, as it is fully genome sequenced, supported by nine published human clinical studies, and is GRAS (generally recognized as safe) with a letter of no-objection from FDA (U.S. Food and Drug Administration). Clinical results show valuable action in immune support, digestive health for adults and children, and improvements in athletic recovery, sports performance and body composition.

Also new is the company’s MuniSpore Bacillus clausii CS108, which possesses properties that support immune function and microbiome modulation. MuniSpore’s unique characteristic among probiotic strains is supporting the body’s natural repair system through antioxidant activity.

Specialty Enzymes & Probiotics also has few new things on the horizon in regard to new ingredients, according to Rathi.

“Companion animals is a market showing continuous growth in probiotics,” Rathi said. “We are working with many customers to bring enzyme and probiotic solutions for their companion animals. We have recently launched a new probiotic for pets: ProbioSEB CSC3 PET (three spore-forming Probiotics and a Prebiotic for a powerful synbiotic).”

Rathi added that the company is also introducing Pepzyme Pro, a digestive enzyme blend for athletes with a probiotic blend to enhance one of its best-selling sports nutrition powder formulas. “The addition of probiotics is showing strong results in studies when it comes to enhancing the absorption of amino acids and increasing branch-chain amino acids (BCAAs),” she noted.

According to Stahl, IFF Health’s newest probiotic innovation is HOWARU Calm, which contains 17 Billion CFU of the HOWARU signature strain, L. paracasei Lpc-37. “While this probiotic strain isn’t new, there is new research suggesting its strong link to stress management, which is in high demand,” she said. In fact, she continued, “Over the last five years, brands around the world launched more than 8,500 new supplements to manage mood, stress, or anxiety. Among those offerings, 333 were probiotic-based, a niche market segment which saw 34 percent growth during that time period.”4

The featured strain has been demonstrated in a clinical trial to help adults manage the psychological response to stress, support brain health by reducing perceived stress in adults, and provide stress relief by helping to balance and regulate general feelings of stress. Additionally, the strain promotes a balanced mood, a relaxed state of mind and supports overall mental well-being.

“Another new trend,” Stahl said, “is combining probiotics with other nutritious ingredients such as botanicals, vitamins or minerals, to boost the benefits. Consumers are looking to holistically address their health concerns without having to take multiple supplements, giving them a more personalized feel. That’s why IFF began investigating live microbe-based solutions, combined with plant-extracts, to deliver effective, multi-faceted wellness support in custom products,” she said. “However, pairing nutritious ingredients with probiotics comes with challenges, such as shelf-life and ingredients interaction. To help brand owners navigate these challenges and more, we rigorously test probiotic strains with complementary ingredients during long-term studies to ensure stability.”

The Scope of Probiotic Use

Along with gut health and immune, consumers are interested in probiotics for vaginal health and depression. Consumer buzz aside, suppliers and manufacturers are looking at research developments that affect probiotics’ practical uses.

Wilhoyte noted that probiotics have long been explored scientifically for their role in supporting the vaginal microbiota and this research continues. “Newer areas of clinical applications for probiotics (as well as prebiotics, synbiotics and postbiotics) are in the skin microbiome, as well as for helping to regulate the gut-brain-axis, which results in better mood and reduced tension. Mood health remains a larger concern due to current economic stress and fears of COVID and other contagious illnesses,” she said.

According to Stahl, “Traditionally, experts have been skeptical about probiotics’ ability to bolster healthy vaginal bacteria. However, emerging research on feminine health demonstrates that a healthy gut microbiota can play a critical role in women’s vaginal and urinary health.5

“About 30-50 percent of women suffer from bacterial vaginosis annually,6 while 70 percent suffer from vulvovaginal candidiasis in their lifetime.7 Vaginal infections are a common result of vaginal microbiota imbalances caused by atypical vaginal bacterial overgrowth. Antibiotics and antifungal medicines are the primary treatments for vaginal infections, but in many cases, they can cause unpleasant side effects. Oftentimes, bacterial vaginosis or vulvovaginal candidiasis recurs. A more natural solution, such as probiotics, may help,” she said.

She pointed out that a randomized, double-blind, placebo-controlled clinical trial8 was conducted, where a group of healthy women consumed two capsules once daily for 14 days. The capsule included a combination of 2 billion L. rhamnosus HN001, 8 billion L. acidophilus La-14 and lactoferrin—IFF’s HOWARU Feminine Health combination. At the end of the supplementation period, women experienced a rise in vaginal Lactobacillus acidophilus and Lacticaseibacillus rhamnosus levels, which continued to increase post-supplementation for at least one week when compared to the placebo group.

In another clinical trial, Stahl said, 40 women with signs or symptoms of vaginosis and an intermediate Nugent score, which indicates a perturbed vaginal microbiota, reported an increase in healthy vaginal bacteria after consuming a combination of L. rhamnosus HN001, L. acidophilus La-14 and lactoferrin consistently for 15 days.9

“Interestingly, results showed significantly higher lactobacilli counts in the probiotic group compared to the placebo group—indicating probiotics’ benefits for balancing vaginal microbiota. The women in the probiotic group also experienced a decrease in self-assessed vaginal symptoms like itching or discharge,” she said.

The effect of the same combination of L. rhamnosus HN001, L. acidophilus La-14 and lactoferrin on clinically diagnosed vaginal infections was investigated in two other separate trials. Women with either bacterial vaginosis10 or vulvovaginal candidiasis11 consumed the probiotic combination, in addition to an antibiotic12 or antifungal treatment.13 The women then continued to take the probiotic or placebo for six months as a way to maintain microbiota balance. Both studies showed that the probiotic supplement provided significant benefits in bacterial vaginosis and vulvovaginal candidiasis management and recovery, when taken along with antibiotic or anti-fungal therapy.

“When it comes to probiotics and depression,” Stahl added, “we can’t speak to a direct link there, but we have seen probiotics have a positive effect on stress management, as mentioned.” While evidence on the exact mechanisms is still emerging, research has demonstrated probiotics’ strong link to the gut microbiota, promoting brain health and reducing perceived stress via the microbiota-gut-brain axis.12

In a randomized, double-blind, placebo-controlled clinical trial to assess HOWARU Calm’s safety and efficacy, researchers at IFF divided 120 healthy adults into two groups and instructed them to take one capsule of either 17 billion CFU of Lpc-37 or a placebo every day for five weeks.13

Participants’ mood, stress and anxiety were assessed at baseline and at the end of the study, in addition to their sleep quality and well-being, which were monitored with an online diary. Following the five-week intervention, participants completed the Trier Social Stress Test (TSST)—considered the most valid and reliable laboratory stress test for humans.

Using the Perceived Stress Scale, the Lpc-37 group reported a significant decrease in perceived stress in the Lpc-37 group compared to the placebo group, from baseline to end-of-study. These positive effects were even more prevalent in women because statistical analyses revealed that the female participants in the Sisu study had higher stress, sleep disruptions and felt less rested after a night sleep, compared to men enrolled in the study.

“This kind of research is essential for supplement manufacturers and brand owners to take heed of,” Stahl noted. “By incorporating clinically backed strains into their products, they’ll be able to produce efficacious end products that help consumers live their healthiest lives. And as consumer knowledge around gut health continue to grow, we predict probiotic products expanding even further to potentially support skin and heart health in the future.”

Finished Product Trends

New developments have led to success with new finished product trends. According to Wilhoyte, “Gummies remain the top dog in non-pill, non-beverage supplements. The beauty of spores such as DE111 and MuniSpore is that their inherent stability allows for production of an array of appealing foods and beverages.”

At IFF Health, Stahl noted, “The success of our probiotic-botanical combination products has led us to develop additional combination supplement concepts, with a personalized approach for women. With women taking charge of their health like never before, “women’s health” is expanding far beyond vaginal health. For example, nearly 50 percent of women reported a rise in stress over the previous five years, compared to 39 percent of men, and only 35 percent of women reported success when trying to manage their stress.”14

The new range of women’s concepts combine probiotics, botanicals and bioscience ingredients, endorsed by science and stability data, Stahl noted. These solutions are backed by consumer insights and carefully designed to meet feminine needs. The Gut & Brain Health product focuses on the microbiota-gut-brain axis to enhance the mind and body; Mindful Beauty is for those looking to enhance their beauty-from-within; and Body Shape offers benefits to control body weight and trunk fat mass by fostering a balanced microbiota.

“In addition to combination tablets or capsules as finished products, delivering probiotic products in exciting delivery formats is a great way for brand owners to appeal to consumers and stand out on shelves,” Stahl said. “While unique F&B (food & beverage) formats have traditionally been challenging for probiotics due to stability issues, we’ve invested our efforts into the research and expertise it takes to produce consumer-centric applications with our HOWARU Probiotic line. In addition to probiotics, our entire portfolio, including other scientifically validated actives, have the capability to be formulated into nutritious F&B formats, with our best-in-class tastes materials.

“At IFF,” Stahl concluded, “we’ve expanded our delivery system options to include drink sachets, ready-to-drink beverages, bars, shots, chocolates, gummies and more—with unlimited opportunity for brand owners to innovate with the confidence that their probiotic strains and actives will remain stable and effective.” NIE

References:

1 Innova Market Insights (Free text search of Mood or Stress or Anxiety positionings within Supplement Product Database. Nutrition Business Journal.

2 Mindbody 2022 wellness index. Mindbody. (n.d.). Retrieved July 21, 2022, from www.mindbodyonline.com/business/education/wi/wellness-index.

3 West, Nicholas P. et al., Probiotic Supplementation for respiratory and gastrointestinal illness symptoms in healthy physically active individuals. Clinical Nutrition, (2014) Volume 33, Issue 4, 581–587.

4 2018 ProVoice Survey of 250 Board Certified Primary Care Physicians.

5 New Hope Network. (2020, July 13). NBJ 2020 supplement business report Predicts Supplement sales growth will spike above 12 percent this Year.

6 Driven by COVID-19. GlobeNewswire News Room.

7 www.frontiersin.org/articles/10.3389/fimmu.2020.02184/full.

8 University of California – San Francisco. “Microbiome therapy protects against recurrent bacterial vaginosis: Reducing this common infection could help prevent HIV and preterm birth.” ScienceDaily. ScienceDaily, 13 May 2020.

9 Gonçalves B, Ferreira C, Alves CT, Henriques M, Azeredo J, Silva S, Crit Rev Microbiol. 2016 Nov.; 42(6):905-27.

10 De Alberti D et al., (2015) Arch Gynecol Obstet 292(4):861-867.

11 Russo R et al., (2018) Arch Gynecol Obstet 298(1):13-145.

12 Russo R et al. (2019) Beneficial Microbes. 10:1, 19-26.

13 Russo R et al. (2019) Mycoses DOI: 10.1111/myc.12883.

14 Cryan, John F et al. “The Microbiota-Gut-Brain Axis.” Physiological Reviews vol. 99,4 (2019): 1877-2013 doi:10.1152/physrev.00018.2018.

For More Information:

Deerland Probiotics and Enzymes (now a part of ADM), www.deerland.com
IFF Health, www.iff.com
Specialty Enzymes & Probiotics, www.specialtyenzymes.com

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