The new probiotics were developed with Bacillus subtilis DE111, a probiotic strain that the supports a healthy digestive system, according to a recent clinical trial that found the strain improves gastrointestinal discomfort and increases the frequency of normal stools in individuals experiencing occasional constipation and/or diarrhea.
"When developing a new product, we look to translate proven science into formulas that deliver efficacious health benefits. So, our team has spent a lot of time formulating these gummies to both taste delicious and equally uphold the highest quality, safety and efficacy standards. We wanted to make sure our gummies checked off all these boxes," noted Eric Bianco, Culturelle brand manager.
The Adult Gummies contain 3 billion colony forming units (CFUs) of Bacillus subtilis DE111 and 2 grams of dietary fiber per serving. The children’s version contains 1.5 billion CFUs of Bacillus subtilis DE111 and under a gram of sugar per serving.
Overcoming format challenges
While gummies work great for multivitamins, the format can present limitations for probiotics. Gummies rely on water soluble ingredients and use high temperatures during the manufacturing process. However, most active ingredients in probiotics are not water soluble and are also temperature sensitive.
Culturelle said the key to defeating such obstacles hinge on the strain.
“We overcame the challenges that are associated with developing an efficacious gummy by choosing the ideal probiotic strain for the gummy format. Gummies have high water content, which is fine for vitamins and minerals but most probiotics, like Lactobacillus rhamnosus GG, are unsuitable for the gummy format. The high moisture of the gummy format does not allow for many traditional probiotics to survive and deliver viable bacteria after storage,” explained Bianco.
“On the other hand, bacilli are spore-formers that live in a dormant state until arriving in the gut. This helps them survive the higher water content of the gummy format. By choosing a clinically supported bacillus strain, Bacillus subtilis DE111, Culturelle Adult and Kids Gummies guarantee potency through expiration date.”
The adult and the childrens gummies are available now.
Immunity and gut health
About 70% of the immune system is housed in the gut, so it’s no wonder probiotic bacteria have been shown to have a number of beneficial immune and health effects.
From mild symptoms to hospital visits and even death, decreased bacteria diversity and gut dysbiosis could be factors that impact the severity of COVID-19 cases.
During a recent NutraCast episode, Chris D’Adamo, PhD, Director of the Center for Integrative Medicine at the University of Maryland School of Medicine, explained that while probiotics for COVID is still under investigation, “We do know that probiotics have been shown to help reduce the frequency, severity and duration of other respiratory illnesses like rhinoviruses, the common cold, influenza as well. So there's certainly biological plausibility that probiotics could help with COVID infection.”
Probiotics to fight COVID
Scientists at Duke University recently received approval for a randomized, double blind, placebo-controlled clinical trial that will use a commercial Culturelle probiotic formulated with Lactobacillus rhamnosus GG (LGG) in COVID-19 exposed households.
The study will be led by Drs. Paul Wischmeyer and Anthony Sung. The Wischmeyer lab and others have previously reported that probiotics, such as LGG, may improve intestinal and lung barrier function and homeostasis, increase regulatory T cells, improve antiviral defenses, and decrease pro-inflammatory cytokines in respiratory and systemic infections.
“Lactobacillus rhamnosus GG was selected for inclusion in the study based on evidence from over 200 clinical trials demonstrating the probiotic strain’s health benefits, including immune support, with select findings demonstrating the probiotic strain’s help in reducing ventilator-associated pneumonia in adult patients and decreasing the risk of upper respiratory tract infections in children attending day care.”
Bianco added that Culturelle is the only commercially available brand in the US with 100% Lactobacillus rhamnosus GG products. i-Health, Inc., marketer of Culturelle, will be providing support for the trial, which is expected to enroll 1,000 participants. Enrollment is currently underway.
The study is slated to wrap up by May 2022, according to clinicaltrials.gov.