ADM spotlights first clinical trial on heat-treated Bifidobacterium longum
Conducted by Vedic Lifesciences and published in Gut Microbes, the study reported that the probiotic Bifidobacterium longum CECT 7347 (ES1) and postbiotic heat-treated Bifidobacterium longum CECT 7347 (HT-ES1) provided a statistically significant and clinically meaningful reduction in IBS-Symptom Severity Scale (SSS) scores compared to placebo.
The researchers conducted a multi-center, randomized, double-blind placebo controlled trial on 200 adults between the ages of 18 and 65 with IBS. Participants received either 1 billion CFU of ES1 probiotic, 2.5 billion equivalent cells of heat-treated ES1 postbiotic (HT-ES1) or a placebo for 12 weeks.
“Digestive health can have a huge impact on everyday quality of life, and this study’s results are key to us delivering solutions that can help consumers focus on their daily activities instead of their abdominal discomfort,” said Dr. Richard Day, vice president of medical affairs and clinical development at ADM. “This trial is the culmination of many years’ hard work by different ADM teams across multiple sites and countries.”
All secondary outcomes were also achieved, showing an improvement in: quality of life (based on the IBS-QoL questionnaire), frequency of watery stools, mean APS-NRS score (abdominal pain numeric rating scale) and stress, as measured by the State-Trait Anxiety Index (STAI).
“The findings from this robust three-arm clinical trial build upon the growing body of evidence showing how supporting the health of the gut microbiome can address aspects of a person’s health and well-being, including digestive health,” Dr. Day. “Taken together with the already extensive preclinical data generated for these two microbiome solution products, this manuscript adds to the already strong scientific dossier for ES1 and HT-ES1. And crucially, this is the first clinical trial to be published using the pioneering HT-ES1.”
The researchers suggest that future trials should address some of the limitations of the study and include RCTs in other geographical locations, controlling for dietary confounders and further exploring potential mechanisms of action.
Heating interest in heat-treated strains
Postbiotics have burst onto the scene over the past couple of years, particularly following the publication of a (somewhat debated) consensus definition by the International Scientific Association for Probiotics and Prebiotics (ISAPP): “A preparation of inanimate microorganisms and/or their components that confers a health benefit on the host".
As a postbiotic, HT-ES1 retains its functionality through various formulation environments like high heat or water content, and formulators do not need to make adaptations for living microorganisms.
Vaughn DuBow, ADM’s global director of marketing for microbiome solutions, told NutraIngredients-USA at SupplySide West 2023 that he predicts that postbiotic sales will match probiotics in the next few years.
“The increasing attention on postbiotics can be attributed to the strains’ robustness,” he said. “When working with heat-treated postbiotics, formulators don’t have to make adaptions for live colony forming units (CFUs).
“This enables postbiotics—such as the heat-treated postbiotic versions of our BPL1 (Bifidobacterium animalis subsp. lactis CECT8145) and ES1 (Bifidobacterium longum CECT7347) strains—to survive during harsh processing conditions like high heat or water content. This makes them suitable for a nearly limitless range of foods, beverages and dietary supplements, answering consumers’ calls for more wellness offerings that can fit their individual lifestyles and personalized goals.”
DuBow also cited data from Frost & Sullivan’s 2023 Growth Opportunities for the Nutrition & Wellness Industry report, which stated that postbiotics are projected to grow at a CAGR of 9.3% between 2021 to 2026.
Source: Gut Microbes
doi: 10.1080/19490976.2024.2338322
"A randomized double-blind, placebo-controlled trial to evaluate the safety and efficacy of live Bifidobacterium longum CECT 7347 (ES1) and heat-treated Bifidobacterium longum CECT 7347 (HT-ES1) in participants with diarrhea-predominant irritable bowel syndrome"
Authors: S Srivastava et al.
