CBM588 Probiotic for Blood Cancer Post-Transplant Care

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Must not be taking: Investigational agents, Antibiotics

Disqualifiers: Pregnancy, Breastfeeding, Chronic intestinal disease, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well a probiotic called CBM588 works in patients who have had a stem cell transplant. These patients often have gut problems and infections. CBM588 aims to increase the variety of good bacteria in their intestines to help with digestion and reduce harmful side effects. Clostridium butyricum MIYAIRI 588 (CBM 588) is a probiotic strain developed for use by humans and animals, known for its beneficial health effects and safety profile.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer.

What data supports the effectiveness of the CBM588 Probiotic treatment for blood cancer post-transplant care?

Research shows that Clostridium butyricum, a component of the CBM588 Probiotic, can help reduce tumor growth and inflammation in colorectal cancer, suggesting it might have beneficial effects in other cancer-related treatments. ^{1 2 3 4 5}

Is Clostridium butyricum CBM 588 Probiotic safe for human use?

Clostridium butyricum CBM 588 has been used as a probiotic, but there are rare cases of bacteremia (bacteria in the blood) reported after surgery, especially in people with weakened immune systems. It's important to discuss potential risks with your doctor, especially if you have a compromised immune system. ^{1 2 6 7 8}

How is the CBM588 probiotic treatment different from other treatments for blood cancer post-transplant care?

CBM588 is unique because it is a probiotic (a beneficial bacteria) that may help improve gut health and reduce inflammation, which is different from traditional treatments that often focus on directly targeting cancer cells. This probiotic has been used in Japan for digestive health and may offer a novel approach by supporting the gut microbiome, potentially aiding recovery and reducing complications after a transplant. ^{1 9 10 11 12}

Research Team

Ryotaro Nakamura

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for patients with blood cancers who are undergoing a donor stem cell transplant. They must be willing to follow the trial for 2 years, have a performance status of at least 60%, and agree to use birth control. Excluded are pregnant or breastfeeding women, those with chronic intestinal diseases, severe allergies to certain antibiotics, uncontrolled illnesses like active infections or hepatitis B/C, HIV positive individuals, other active malignancies within the last 2 years (except certain skin cancers and cervical cancer in-situ), or severe lactose intolerance.

Inclusion Criteria

I am scheduled for a stem cell transplant with a closely matched donor.

I am eligible for a specific type of bone marrow transplant.

Documented informed consent of the participant and/or legally authorized representative

Exclusion Criteria

I understand the study's purpose, procedures, and the risks/benefits involved.

I do not have any uncontrolled illnesses or active infections, including hepatitis B or C, and I am not HIV positive.

Refusing to use contraception up to 90 days post-HCT

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive standard peri-/post-transplant supportive care and CBM588 orally twice daily from day of admission to day 28

4 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

100 days

Long-term Follow-up

Participants are monitored for overall survival, incidence of GVHD, and microbiome diversity

Up to 2 years

Treatment Details

Interventions

• Clostridium butyricum CBM 588 Probiotic Strain

Trial Overview The trial tests CBM588 probiotic strain's effectiveness in improving gut bacteria diversity and preventing gastrointestinal issues after stem cell transplants. It's compared against standard practices in patients who've had reduced intensity conditioning before their transplant.

Participant Groups

Group I: Arm I (CBM588) Experimental Treatment 2 Interventions

Patients receive standard peri-/post-transplant supportive care and CBM588 PO BID from day of admission to day 28 in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (standard of care) Active Control 1 Intervention

Patients receive standard peri-/post-transplant supportive care.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. China pubmed.ncbi.nlm.nih.gov

Clostridium butyricum inhibits the progression of colorectal cancer and alleviates intestinal inflammation via the myeloid differentiation factor 88 (MyD88)-nuclear factor-kappa B (NF-κB) signaling pathway. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Probiotics Clostridium butyricum and Bacillus subtilis ameliorate intestinal tumorigenesis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Spiking immunotherapy with a bacterial cocktail brings T cells back to the fight. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Therapeutic potential of Clostridium butyricum anticancer effects in colorectal cancer. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Commensal Clostridiales strains mediate effective anti-cancer immune response against solid tumors. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Lactobacillus bloodstream infections genetically related to probiotic use in pediatric hematopoietic cell transplant patients. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Clostridium butyricum modulates gut microbiota and reduces colitis associated colon cancer in mice. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Probiotic-related bacteremia after major hepatectomy for biliary cancer: a report of two cases. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Safety assessment of the Clostridium butyricum MIYAIRI 588® probiotic strain including evaluation of antimicrobial sensitivity and presence of Clostridium toxin genes in vitro and teratogenicity in vivo. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of Clostridium butyricum on fecal flora in Helicobacter pylori eradication therapy. [2019]

11. England pubmed.ncbi.nlm.nih.gov

The impact of Clostridium butyricum MIYAIRI 588 on the murine gut microbiome and colonic tissue. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of probiotic Clostridium butyricum MIYAIRI 588 on murine gut metabolic alterations. [2019]