Could a probiotic help stem cell transplant recovery?
NCT ID NCT03922035
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether a probiotic called CBM588 is safe and can improve outcomes in 36 patients who have received a donor stem cell transplant. The probiotic aims to increase healthy gut bacteria and reduce gut-related side effects like diarrhea and colon inflammation. The study primarily looks at safety and whether patients can take the probiotic as directed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Clostridium butyricum MIYAIRI 588 (CBM588) probiotic
- What this could lead to
- If it works, this could point toward a simple probiotic to reduce gut complications and improve recovery after stem cell transplants.
- What could go wrong
- This is a very small, early-phase pilot study (36 people) focused mainly on safety and feasibility. It is too early to know if the probiotic truly helps, and results may not apply to all transplant patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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36 people
The number who actually took part.
- Started
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Apr 2019
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines. * Willingness to be followed for the planned duration of the trial (2 years). * Karnofsky performance status must be \>= 60%. * Any hematologic disorders receiving allogeneic hematopoietic stem cell transplant with reduced intensity conditioning. * Planned 8/8 or 7/8 (human leukocyte antigens \[HLA\]-A, B, C, DR) related or unrelated donor hematopoietic cell transplantation (HCT). * Clinical Laboratory and Organ Function Criteria: Consistent with City of Hope (COH) standard operating procedure (SOP) for "patient evaluation for selection for hematopoietic cell transplantation. * Patient is eligible to receive allogeneic hematopoietic cell transplantation with reduced intensity conditioning. * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy. * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only). Exclusion Criteria: * Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this pilot study. A legal guardian may substitute for the research participant. * Refusing to use contraception up to 90 days post-HCT. * Pregnant and/or breast feeding if a female recipient. * Patients with history of chronic intestinal disease (e.g., Crohn's disease, ulcerative colitis). * In the opinion of the principal investigator (PI), the participant has a condition that will preclude them from complying with study treatment. * Research participants receiving any other investigational agents. * Known or documented history of hypersensitivity to all the listed antibiotics, used for severe infections related to CBM588: * Ampicillin. * Chloramphenicol. * Clindamycin. * Erythromycin. * Metronidazole. * Tetracycline. * Vancomycin. * Research participants with presence of other active malignancy within 2 years of study entry. Participants with history of prior malignancy treated with curative intent who achieved complete response (CR) more than 2 years before study entry are eligible. This exclusion rule does not apply to non-melanoma skin tumors and in-situ cervical cancer. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent (i.e., research participants whom are severe lactose intolerance or intolerance to milk products). * Research participants having any uncontrolled illness including ongoing or active infection. Research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures, or radiological evidence of infections. * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures. * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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