Efficacy of Bacillus clausii UBBC-07 and Bacillus coagulans Unique IS-2 in Mitigating Pulmonary Parameters in Patients With Moderate COVID-19 Symptoms.

2024-12-26
Cureus 16(12)
- Mehdi Ali Mirza
- Rajiv Kumar Bandaru
- Ushasree T

PubMed: 39866999
DOI: 10.7759/cureus.76436

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 56
Population: 56 patients with moderate COVID-19 symptoms
Methods: randomized, double-blind, placebo-controlled, three-arm parallel-group study; standard treatment combined with Bacillus clausii UBBC-07, Bacillus coagulans Unique IS-2, or placebo; oral suspension containing 2 billion spores twice daily for 14 days

Probiotics have shown efficacy in preventing and reducing infections caused by common viruses, including rotavirus, norovirus, hepatitis, human papillomavirus (HPV), human immunodeficiency virus (HIV), and herpes simplex virus (HSV). A randomized, double-blind, placebo-controlled, three-arm parallel-group study was conducted on 56 patients with moderate COVID-19 symptoms. Patients were randomly assigned to one of the three groups: standard treatment combined with Bacillus clausii UBBC-07, standard treatment combined with Bacillus coagulans Unique IS-2, or standard treatment with a placebo. The probiotics were administered as an oral suspension containing 2 billion spores, taken twice daily for 14 days. The placebo group received distilled water administered twice daily for 14 days. Clinical recovery and respiratory parameters were assessed, with C-reactive protein (CRP), serum ferritin, and lactate dehydrogenase (LDH) levels measured on days one, seven, and 14, while D-dimer and interleukin-6 levels were evaluated on days one and 14. There was a significant reduction (p < 0.01) in serum ferritin levels for both Bacillus clausii UBBC-07 and Bacillus coagulans Unique IS-2 compared to the placebo group. The median reduction in serum ferritin levels on day seven was 345 μg/L (39.2%) in the Bacillus clausii UBBC-07 group, 350 μg/L (40.7%) in the Bacillus coagulans Unique IS-2 group, and 270 μg/L (30.9%) in the placebo group. By day 14, the reductions were 665 μg/L (75.6%) for the Bacillus clausii UBBC-07 group, 630 μg/L (73.3%) for the Bacillus coagulans Unique IS-2 group, and 595 μg/L (69.1%) for the placebo group. D-dimer levels were significantly reduced by the end of treatment (day 14) in the Bacillus coagulans Unique IS-2 group compared to the placebo group, with median decreases of 0.36 μg/ml (60.0%) for Bacillus coagulans Unique IS-2, 0.21 μg/ml (36.8%) for Bacillus clausii UBBC-07, and 0.22 μg/ml (34.4%) for the placebo group. No significant differences were observed in other biomarkers, including CRP, LDH, and interleukin-6. No adverse effects related to probiotic administration were observed, and the intervention was well tolerated by all patients. In conclusion, Bacillus coagulans Unique IS-2 and Bacillus clausii UBBC-07 may be considered adjunct therapies for mitigating COVID-19 infections.

Research Insights

Bacillus coagulans Unique IS-2→Reduced C-Reactive Protein Levels
No significant differences were observed in other biomarkers, including CRP, LDH, and interleukin-6.
Effect
Neutral
Effect size
Small
Dose
2 billion spores, twice daily for 14 days
Bacillus coagulans Unique IS-2→Reduced D-Dimer Level
D-dimer levels were significantly reduced by the end of treatment (day 14) in the Bacillus coagulans Unique IS-2 group compared to the placebo group, with median decreases of 0.36 μg/ml (60.0%) for Bacillus coagulans Unique IS-2...
Effect
Beneficial
Effect size
Large
Dose
2 billion spores, twice daily for 14 days
Bacillus coagulans Unique IS-2→Reduced Ferritin Level
There was a significant reduction (p < 0.01) in serum ferritin levels for both Bacillus clausii UBBC-07 and Bacillus coagulans Unique IS-2 compared to the placebo group. The median reduction in serum ferritin levels on day seven was 350 μg/L (40.7%) in the Bacillus coagulans Unique IS-2 group...By day 14, the reductions were 630 μg/L (73.3%)
Effect
Beneficial
Effect size
Large
Dose
2 billion spores, twice daily for 14 days
Bacillus coagulans Unique IS-2→Reduced Interleukin-6 Levels
No significant differences were observed in other biomarkers, including CRP, LDH, and interleukin-6.
Effect
Neutral
Effect size
Small
Dose
2 billion spores, twice daily for 14 days
Bacillus coagulans Unique IS-2→Reduced Lactate Dehydrogenase Level
No significant differences were observed in other biomarkers, including CRP, LDH, and interleukin-6.
Effect
Neutral
Effect size
Small
Dose
2 billion spores, twice daily for 14 days

Adverse Events Reported

Bacillus coagulans Unique IS-2→Overall tolerability
No adverse effects related to probiotic administration were observed, and the intervention was well tolerated by all patients.
Finding
Reported