Clostridium butyricum MIYAIRI 588 contributes to the maintenance of intestinal microbiota diversity early after haematopoietic cell transplantation - Scorecard - MDSpire

Clostridium butyricum MIYAIRI 588 contributes to the maintenance of intestinal microbiota diversity early after haematopoietic cell transplantation

  • By

  • Kentaro Fukushima

  • Hayami Kudo

  • Kentaro Oka

  • Atsushi Hayashi

  • Makoto Onizuka

  • Shinsuke Kusakabe

  • Akihisa Hino

  • Motomichi Takahashi

  • Kiyoshi Takeda

  • Masaki Mori

  • Kiyoshi Ando

  • Naoki Hosen

  • March 2, 2024

  • 0 min

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Clinical Scorecard: The Role of Clostridium butyricum MIYAIRI 588 in Preserving Intestinal Microbiota Diversity Following Early Hematopoietic Cell Transplantation

At a Glance

CategoryDetail
ConditionIntestinal microbiota disruption following hematopoietic stem cell transplantation (HSCT)
Key MechanismsCBM588, a live biotherapeutic product, modulates gut microbiota by increasing beneficial bacteria such as Bifidobacterium, Lactobacillus, and Lactococcus, and exhibits tolerance to stressors including antimicrobials
Target PopulationPatients undergoing allogeneic hematopoietic stem cell transplantation
Care SettingPeri-transplant period in hospital settings performing HSCT

Key Highlights

  • CBM588 is a spore-forming anaerobic bacterium classified as a live biotherapeutic product used to treat and prevent microbial dysbiosis-related digestive symptoms.
  • Prophylactic administration of CBM588 during HSCT may help preserve intestinal microbiota diversity and improve microbial balance disrupted by conditioning chemotherapy and antimicrobials.
  • A randomized pilot study is underway to assess the safety and feasibility of CBM588 administration in the peri-transplant period.

Guideline-Based Recommendations

Diagnosis

  • Monitor intestinal microbiota diversity using 16S rRNA amplicon sequencing before and after HSCT.
  • Use quantitative PCR to quantify C. butyricum and total bacterial load in fecal samples.

Management

  • Administer 60 mg oral CBM588 daily alongside usual postoperative antimicrobials during the peri-transplant period.
  • Collect and analyze fecal samples weekly from 7 days before HSCT to 35 days post-transplant to monitor microbiota changes.

Monitoring & Follow-up

  • Regularly assess alpha diversity and microbial composition via sequencing and qPCR to evaluate microbiota stability.
  • Monitor for incidence and severity of acute graft-versus-host disease (aGVHD) and other adverse events during CBM588 administration.

Risks

  • Safety and efficacy of microbial interventions post-HSCT remain under investigation; careful monitoring for adverse events is essential.
  • Potential variability in microbiota response due to conditioning regimens and antimicrobial treatments.

Patient & Prescribing Data

Japanese patients undergoing allogeneic HSCT

CBM588 administration is feasible and may normalize intestinal microbiota disturbed by antibiotics and conditioning regimens, potentially improving clinical outcomes.

Clinical Best Practices

  • Obtain informed consent and adhere to institutional review board approvals and ethical guidelines.
  • Ensure accurate and timely collection of fecal samples for microbiota analysis.
  • Use validated molecular techniques such as 16S rRNA sequencing and qPCR for microbiota assessment.
  • Combine CBM588 administration with standard antimicrobial prophylaxis during HSCT.
  • Monitor patients closely for gastrointestinal symptoms and graft-versus-host disease.

References

Original Source(s)

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