Clinical Report: Clostridium butyricum MIYAIRI 588 Preserves Gut Microbiota Post-HSCT

Overview

This study evaluated the effects of prophylactic administration of Clostridium butyricum MIYAIRI 588 (CBM588) on intestinal microbiota diversity following allogeneic hematopoietic stem cell transplantation (HSCT). Using 16S rRNA amplicon sequencing, CBM588 was shown to help maintain microbiota stability during the peri-transplant period, which is critical for patient prognosis.

Background

The intestinal microbiota is essential for regulating digestion, metabolism, and immune function. HSCT is a curative treatment for hematological diseases but disrupts the gut microbiota due to conditioning regimens and antimicrobial therapies. Stability of the intestinal microbiota post-transplant correlates with improved outcomes. CBM588, a spore-forming anaerobic bacterium classified as a live biotherapeutic product, has demonstrated efficacy in preventing antibiotic-associated dysbiosis and is used clinically in Japan. This study investigates CBM588's role in preserving gut microbiota diversity after HSCT.

Data Highlights

Forty Japanese patients undergoing allogeneic HSCT were enrolled, with 196 fecal samples collected longitudinally from 37 patients. Samples were collected at baseline (7 days pre-HSCT) and weekly up to 35 days post-HSCT. 16S rRNA gene sequencing targeted the V3–V4 region, and quantitative PCR assessed C. butyricum abundance. CBM588 was administered orally at 60 mg daily alongside standard antimicrobials.

Key Findings

• CBM588 administration was associated with preservation of intestinal microbiota diversity during the peri-transplant period.
• 16S rRNA sequencing revealed increased abundance of beneficial genera such as Bifidobacterium, Lactobacillus, and Lactococcus in patients receiving CBM588.
• Quantitative PCR confirmed increased colonization of C. butyricum in the gut following CBM588 administration.
• Microbiota stability correlated with reduced incidence and severity of acute graft-versus-host disease (aGVHD).
• CBM588 demonstrated tolerance to stressors including low pH and antimicrobials, supporting its efficacy during HSCT conditioning and treatment.

Clinical Implications

Prophylactic use of CBM588 during HSCT may help maintain gut microbiota diversity, potentially improving transplant outcomes and reducing complications such as aGVHD. Its resilience to antimicrobial agents makes it a promising adjunct to standard care in the peri-transplant period. Further randomized studies are warranted to confirm safety and efficacy.

Conclusion

CBM588 shows promise as a live biotherapeutic product to preserve intestinal microbiota diversity following HSCT, which may contribute to better clinical outcomes. This study supports its potential role in microbial intervention strategies during transplantation.

References

1. Miyarisan Pharmaceutical Co., Ltd. -- CBM588 Clinical Use and Properties
2. NCT03922035 -- Randomised Pilot Study of CBM588 in HSCT Patients
3. QIIME 2 Platform -- Microbiota Sequencing Analysis