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CBM588 Probiotic for Blood Cancer Post-Transplant Care
Phase 1
Waitlist Available
Led By Ryotaro Nakamura
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a drug to help improve outcomes for people who have had a stem cell transplant from a donor. The drug may help increase gut bacteria biodiversity and prevent recurrent gastrointestinal symptoms.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include digestive disturbances such as diarrhea due to changes in gut microbiota from taking CBM588. Since it aims to prevent inflammation of the colon and other GI toxicity symptoms post-transplant, fewer serious side effects are expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of CBM588
Incidence of adverse events
Secondary outcome measures
CI of acute graft versus host disease (aGVHD)
CI of relapse/progression of disease
Cumulative incidence (CI) of chronic graft versus host disease (cGVHD)
+3 moreOther outcome measures
Gut microbiome diversity
Gut microbiome diversity aGVHD incidence
Gut microbiome diversity and bloodstream infection
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (CBM588)Experimental Treatment2 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 Control1 Intervention
Patients receive standard peri-/post-transplant supportive care.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,117 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,424 Total Patients Enrolled
Ryotaro NakamuraPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
216 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.I am currently pregnant or breastfeeding.I have a chronic intestinal condition like Crohn's disease or ulcerative colitis.I have not had any other cancer except for non-melanoma skin cancer or in-situ cervical cancer in the last 2 years.I can care for myself but may need occasional help.I have a blood disorder and received a stem cell transplant with mild preparation.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (standard of care)
- Group 2: Arm I (CBM588)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with the condition still being enrolled in this research project?
"According to the clinicaltrials.gov website, this particular trial is not currently recruiting patients. It was first posted on April 18th, 2019 and was last updated on February 17th, 2022. There are, however, 365 other trials that are actively recruiting patients."
Answered by AI
Do patients experience any adverse effects from Clostridium butyricum CBM 588 Probiotic Strain?
"Clostridium butyricum CBM 588 Probiotic Strain is in Phase 1 of clinical trials, so there is limited data to support its safety."
Answered by AI
What are the benefits that researchers hope to see from this study?
"The research team will be measuring the primary outcome, adverse events, during the safety lead-in phase. Additionally, they will be looking at overall survival, using the Kaplan and Meier method, as well as the cumulative incidence of acute and chronic graft versus host disease."
Answered by AI
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