Placebo-controlled, randomised study. In-vitro investigations at a university hospital. Microbiome analyses. An overview of the scientific evidence base for Bacillus subtilis MM40® (DSM 21097; Budapest Treaty DSM 33619; EU Trademark No. 018279328).
Disclaimer: The data presented originate from individual studies. Further research is required. These are not approved health claims under EU Regulation 1924/2006.
In a placebo-controlled, randomised study at Medicom In Medical Center, Dnipro (Vogel et al., April 2026), 72 adults were randomized; 70 completers (37 probiotic, 33 placebo) entered the analysis. The following changes were documented in the probiotic group compared to placebo.
Source: Vogel W, Minch S, Prydyus I, Kryzhanovska N. Bacillus subtilis MM40® (DSM 21097) supplementation in metabolic syndrome. Placebo-controlled 12-week RCT at Medicom In Medical Center, Dnipro (April 2026); n = 72 randomized / 70 completers. The data originate from a single clinical study and are not yet peer-reviewed. Further research is required.
The placebo-controlled, randomised study is considered the gold standard of clinical research. Blinding of both subjects and investigators minimizes the influence of subjective factors.
Randomization ensures that both groups - verum and placebo - have comparable baseline conditions. This enables a robust interpretation of the observed changes.
Note: A single study does not permit definitive conclusions. Further investigations are required to confirm the results.
Agar diffusion tests (Hemmhoftest) with MM40® against selected reference organisms were conducted at the University Hospital Schleswig-Holstein (UKSH), Campus Lübeck.
Inhibition zone observed
In the agar diffusion test, MM40® showed a measurable inhibition
zone against methicillin-resistant Staphylococcus aureus (MRSA).
Control strain CU1: 0 mm inhibition zone
Inhibition zone observed
MM40® also demonstrated an inhibition zone against
Proteus mirabilis in the agar diffusion test.
Control strain CU1: 0 mm inhibition zone
The reference strain B. subtilis CU1 showed no measurable inhibition zones (0 mm) against MRSA and Proteus mirabilis in the same test setup.
Method: Agar diffusion test (UKSH Lübeck)
Note: In-vitro results. Laboratory investigations do not permit direct conclusions regarding efficacy in the human organism. Further research is required. Source: Agar diffusion test, UKSH Lübeck.
In addition to the primary metabolic endpoints, the clinical study also investigated shifts in gut microbiome composition. The following observations were documented in the verum group:
Source: Secondary endpoints of the RCT with B. subtilis MM40® (DSM 21097); n = 72 randomized / 70 completers; microbiota subgroup n = 38; 12 weeks. The data originate from a single clinical study.
The data presented on this page originate from individual studies and laboratory investigations. Further research is required to confirm the results. These are not approved health claims under EU Regulation 1924/2006. In-vitro results do not permit direct conclusions regarding efficacy in the human organism. The language used on this page describes observations and study results and does not constitute healing claims, efficacy promises, or therapeutic recommendations.
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