Bacillus subtilis
Shelf-stable spore-forming probiotic with promising but still-preliminary human GI and immune data
What is Bacillus subtilis?
Bacillus subtilis (Bacillus subtilis (DE111 / R0179)) is a probiotic strain used for reduces days of vomiting and hard stools / occasional gi discomfort in young children (de111, 1 billion cfu/day). NutriDex grades the human evidence as Preliminary. Bacillus subtilis is a spore-forming probiotic whose acid-resistant spores survive gastric transit; both DE111 and R0179 designations have been shown in human RCTs to reach and germinate in the small intestine and to be well tolerated. The strongest data are for digestive comfort: in a 2021 RCT of 102 daycare children, DE111 (1 billion CFU/day x 8 weeks) reduced days of vomiting and hard stools versus placebo. In healthy adults, a 2021 pilot RCT (n=44) found DE111 enhanced regulatory T-cell responses but left most GI symptom and inflammation markers largely unchanged, and a 2015 R0179 dose-ranging trial (n=81) confirmed tolerability and GI survival without persistent microbiota shifts. Overall the human evidence is positive but small and pilot-grade — no large meta-analyses yet exist for these specific strains.
Purported Benefits
Evidence by outcome
The same supplement can be well-proven for one use and unproven for another — here is the human evidence graded outcome by outcome.
| Outcome | Evidence | Effect | Studies |
|---|---|---|---|
| Reduces GI discomfort (vomiting, hard stools) in young childrenSingle 102-child RCT of DE111 showed fewer days of vomiting/hard stools; not yet replicated or meta-analyzed. | Preliminary | ↑ benefit · moderate | 1 |
| Improves bowel-movement profile in healthy adultsOne small RCT showed improved bowel profile, but a second pilot found GI symptoms largely unchanged. | Preliminary | ↔ mixed · small | 2 |
| Survives gastric transit and germinates in small intestineIleostomy and dose-ranging RCTs confirm spore survival/germination; a delivery property, not a clinical outcome. | Moderate | ↑ benefit · moderate | 2 |
| Enhances regulatory T-cell (Treg) immune responseSingle n=44 pilot RCT showed increased Tregs after LPS challenge; surrogate marker, no clinical endpoint. | Preliminary | ↑ benefit | 1 |
| Reduces body-fat percentage with resistance trainingOne small female-athlete RCT showed greater fat loss; a male-athlete RCT found no body-composition change. | Preliminary | ↔ mixed · small | 2 |
| Attenuates circulating TNF-alpha in athletesSingle 25-athlete RCT showed lower TNF-alpha; inflammatory biomarker only, no clinical correlate. | Preliminary | ↑ benefit | 1 |