Table 3.
Clinical benefits of B. clausii administration.
| Strain (Dose) | Study Design | Disease | Efficacy | Reference |
|---|---|---|---|---|
| O/C, N/R, SIN, T (2 × 109 to 4 × 109 CFU/day) | Prospective, open-label, multi-center, observational study; n = 3178 | Acute pediatric diarrhea | Reduced duration of diarrhea | [76] |
| O/C, SIN, N/R, T (2 × 109 to 4 × 109 CFU/day) |
Meta-analysis; n = 898 from 6 studies | Rotavirus infection | Reduced frequency and duration of diarrhea Shortened hospital stay |
[77] |
| O/C, SIN, N/R, T (6 × 109 spores/day) |
Single-center, double blind, randomized, placebo-controlled prospective study; n = 120 Randomized, double blind, single-center, placebo-controlled, parallel group, phase 3b study; n = 130 |
Helicobacter pylori treatment | Reduced nausea, diarrhea, and epigastric pain Fewer days of diarrhea Lower incidence of diarrhea |
[27,28] |
| O/C, SIN, N/R, T | Randomized, double-blind, placebo-controlled trial; n = 244 | Necrotizing enterocolitis and late-onset sepsis | Faster attainment of full feeds | [78] |
| O/C, SIN, N/R, T | Randomized, single-blind, multi-center, two arm parallel group study; n = 80 | Upper respiratory tract infections | Fewer and shorter duration of infections | [79] |
| O/C, SIN, N/R, T | Single-blind, non-controlled study; n = 10 | Allergic rhinitis | Reduction in pro-inflammatory cytokines, higher levels of anti-inflammatory cytokines | [80,81] |
| UBBC07 (4 × 109 spores/day) | Randomized, double-blind, placebo-controlled trial; n = 153 | Acute pediatric diarrhea | Reduced stool frequency and duration of diarrhea | [82] |
| Unknown | Observational study; n = 65 | Rotavirus infection | Normalization of IgA and IgM to pre-infection levels Reduction in general weakness, swelling, and/or abdominal pain, fever, vomiting, and duration of diarrhea |
[83,84] |
| Mix of Bacillus species, strain of B. clausii unavailable | Randomized, double-blind, placebo-controlled study with pre-screening for responders; n = 28 | Endotoxemia | Reduction in serum endotoxin and serum triglycerides, reduction in levels of pro-inflammatory markers | [85] |
| Unknown | Randomized controlled study; n = 80 | Recurrent aphthous stomatitis | Reduction in erythema, pain, burning sensation, and oral thrush | [86] |