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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the CBM588 probiotic can aid patients with blood cancer who have undergone a donor stem cell transplant. The focus is on enhancing gut health, potentially reducing issues like diarrhea and severe colon inflammation post-transplant. Participants will receive either the probiotic with standard care or just the usual care to determine the probiotic's impact. The trial seeks patients who have had a donor stem cell transplant due to blood disorders and do not have chronic intestinal diseases like Crohn's disease. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that Clostridium butyricum, known as the probiotic strain CBM588, has been used safely for many years. Studies indicate that it produces butyrate, which supports gut health. Other research has found that people taking CBM588 have a greater variety of gut bacteria, benefiting digestion.

Although this trial is in its early stages, the long history of using CBM588 as a probiotic suggests it is generally well-tolerated. Reviewed studies have reported no major harmful effects. This suggests that CBM588 might be a safe option for those who have had a stem cell transplant and want to improve their gut health. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for blood cancer post-transplant care, which typically involves supportive treatments to manage symptoms and side effects, CBM588 uses a probiotic strain called Clostridium butyricum. This probiotic is thought to improve gut health and immune function, potentially reducing complications after a transplant. Researchers are excited about CBM588 because it introduces a novel way to support patients by enhancing their gut microbiome, which might lead to better overall recovery and fewer side effects compared to the usual supportive care alone.

What evidence suggests that CBM588 might be an effective treatment for blood cancer post-transplant care?

Research has shown that Clostridium butyricum, the main ingredient in the CBM588 probiotic, may help reduce inflammation and slow tumor growth in certain cancers, such as colorectal cancer. Studies have found that this probiotic can increase the variety of gut bacteria, which is crucial for maintaining a healthy digestive system. In animal studies, CBM588 improved health outcomes and supported gut health. In this trial, participants in one arm will receive CBM588 alongside standard peri-/post-transplant supportive care. Additionally, when combined with other cancer treatments, CBM588 has been linked to better recovery in some cancers. These findings suggest that CBM588 might enhance gut health and overall recovery in patients after a stem cell transplant. ^{1 2 3 6 7}

Who Is on the Research Team?

Ryotaro Nakamura

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-1-hematologic-neoplasms-3-2019-ae277

CBM588 Probiotic 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 ...

2. clinicaltrial.be clinicaltrial.be/fr/details/5464?per_page=100&only_recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

CBM588 in Improving Clinical Outcomes in Patients Who ... Patients receive standard peri-/post-transplant supportive care and CBM588 PO BID from day of admission to day 28 in the absence of disease ...

3. wwwnc.cdc.gov wwwnc.cdc.gov/eid/article/30/4/23-1633_article

Clostridium butyricum Bacteremia Associated with ... Numerous studies have substantiated the effectiveness of CBM 588, and various animal model experiments have demonstrated its capacity to ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05122546

Study Details | NCT05122546 | CBM588 in Combination ... This phase I trial evaluates the effects of CBM588 in combination with standard therapies, nivolumab and cabozantinib, in treating patients with kidney cancer.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12325897/

Prognostic Impact of Clostridium butyricum MIYAIRI ... Combining the probiotic product CBM588 with immune checkpoint inhibitors (ICIs) has shown improved prognosis in several cancers.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8078720/

Butyrate-producing human gut symbiont, Clostridium ... Clostridium butyricum is a butyrate-producing human gut symbiont that has been safely used as a probiotic for decades.

7. researchgate.net researchgate.net/publication/378682567_Clostridium_butyricum_MIYAIRI_588_contributes_to_the_maintenance_of_intestinal_microbiota_diversity_early_after_haematopoietic_cell_transplantation

(PDF) Clostridium butyricum MIYAIRI 588 contributes to the ... Patients who received CBM588 exhibited a contrasting trend, with lower relative abundances of both genera Enterococcus and Bacteroides. These ...