Malignant Solid NeoplasmNCT06508034
Probiotics for the Prevention of Immunotherapy Induced Colitis in Patients Receiving Immunotherapy
A study testing Biospecimen Collection, Live Freeze-Dried Lactic Acid Bacteria Probiotic and Questionnaire Administration in people with Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
The clinical trial tests the use of over-the-counter probiotics VSL#3® 450B in patients receiving immunotherapy. Immunotherapy with monoclonal antibodies, helps the body's immune system attack tumor cells, and interferes with the ability of tumor cells to grow and spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Neoplasm
- What is being tested?
- Biospecimen Collection, Live Freeze-Dried Lactic Acid Bacteria Probiotic and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Histologically confirmed solid malignancy
- Will be starting on ICIs or have started ≤ 2 cycles of ICIs
- For cohort 1: Ipilimumab with or without anti-PD-1/PD-L1 including but not limited to pembrolizumab, nivolumab, cemiplimab, atezolizumab, avelumab, or durvalumab
- For cohort 2: Anti-PD-1/PD-L1 described above with or without chemotherapy
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- Absolute neutrophil count (ANC) ≥ 1000/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- Creatinine ≤ 2 x upper limit of normal (ULN)
- Serum glutamic-oxaloacetic transaminase (SGOT) [aspartate transaminase (AST)] ≤ 2 x ULN
- Albumin ≥ 3 g/dL
- Willing and able to provide research stool and blood samples
- Negative serum pregnancy test done ≤ 7 days prior to enrollment, for women of childbearing potential only
- Capable of providing valid informed consent
- Willing to return to enrolling institution for all study visits (blood draws, etc)
Who cannot join
- Requires prolonged systemic antibiotic therapy for other condition and recent systemic antibiotic within the past 2 weeks
- Fecal microbiota transplant (FMT) within the past 6 months
- FMT with an associated serious adverse event related to the FMT product or procedure
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of over-the-counter probiotics
- Immunocompromised patients including patients known to be HIV positive or those on chronic steroids > 20 mg prednisone a day or prednisone-equivalent Note: Must be off systemic steroids at least 90 days prior to enrollment. However, topical steroids, inhalants or steroid eye drops are permitted
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis
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- History of chronic diarrhea
- History of celiac disease
- Currently has a colostomy
- Intraabdominal surgery related to gastrointestinal tract within the last 60 days
- Evidence of active, severe colitis
- History of short gut syndrome or motility disorders
- Requires the regular use of medications to manage bowel hypermotility
- Active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to randomization. Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis
The clinical trial tests the use of over-the-counter probiotics VSL#3® 450B in patients receiving immunotherapy. Immunotherapy with monoclonal antibodies, helps the body's immune system attack tumor cells, and interferes with the ability of tumor cells to grow and spread. Immunotherapy can also cause an unfortunate side effect of inflammation of the colon and diarrhea, also known as immune checkpoint inhibitor induced colitis. Immune checkpoint inhibitor induced colitis can occur in up to 45% of patients receiving immunotherapy. Taking probiotics VSL#3® 450B may reduce the chances of developing immune checkpoint inhibitor induced colitis in patients receiving immunotherapy.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the incidence of immune checkpoint inhibitors (ICI)-induced colitis (IIC) in patients with solid malignancies receiving over-the-counter multi-strain probiotic blend and ICIs in both cohorts: (1) anti-Cytotoxic T lymphocyte-associated protein-4 (CTLA-4) +/- anti-programmed cell death-1 (PD-1)/programmed cell death-1 ligand 1 (PD-L1), and (2) anti-PD-1/PD-L1 +/- chemo.
SECONDARY OBJECTIVES:
- To evaluate the safety of multi-strain probiotic blend in cancer patients receiving ICIs.
II. To evaluate the clinical outcomes related to IIC, including the incidence of IIC, hospitalization, treatment delays, and administration of immunosuppressants.
EXPLORATORY OBJECTIVES:
- To evaluate changes in gut microbiome with ICIs and multi-strain probiotic blend.
II. To evaluate changes in immune response with ICIs and multi-strain probiotic blend.
OUTLINE:
Patients receive VSL#3® 450B (live freeze-dried lactic acid bacteria probiotic) orally (PO) once daily (QD) at least 3 days prior or 1-2 weeks prior to starting standard care ICIs or receiving the next cycle of ICIs and then continue for 12 weeks. Patients also undergo stool and blood sample collections on study.
After completion of study treatment, patients are followed up at 30 days and 1 year.
- Conditions
- Malignant Solid Neoplasm
- Being tested
- Biospecimen Collection, Live Freeze-Dried Lactic Acid Bacteria Probiotic, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo stool and blood sample collection
Live Freeze-Dried Lactic Acid Bacteria ProbioticDietary supplement
Also called VSL#3, VSL3
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (VSL#3® 450B) | Experimental | Patients receive VSL#3® 450B (live freeze-dried lactic acid bacteria probiotic) PO QD at least 3 days prior or 1-2 weeks prior to starting standard care or receiving the next cycle of ICIs and then continue for 12 weeks. Patients also undergo stool and blood sample collections on study. Receives: Procedure: Biospecimen Collection; Dietary Supplement: Live Freeze-Dried Lactic Acid Bacteria Probiotic; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of immune checkpoint inhibitors (ICI)-induced colitis (IIC) with VSL#3 and ICIs
Will be evaluated in patients with solid malignancies in 2 cohorts, including 1) anti-CTLA4 ± anti-PD-1/PD-L1, 2) anti-PD-1/PD-L1 ± chemotherapy respectively. Analysis will be performed in all-treated population, defined as any subject enrolled into the study that received at least 3 days of VSL#3 and anti-PD-1/PD-L1. The statistical analyses will be handled in a descriptive manner. Will be estimated by the number of patients who had IIC divided by the total number of evaluable patients. Two-sided 90% exact confidence intervals for the true incidence rate will be calculated according to the approach of Clopper and Pearson.
Measured: Up to 14 weeks
Secondary outcomes (4)
Incidence of adverse events
Will be evaluated by the safety profile of multi-strain probiotic blend in cancer patients receiving ICIs. Analysis will be performed in all-treated population, defined as any subject enrolled into the study that received at least 3 days of VSL#3 and anti-PD-1/PD-L1. The statistical analyses will be handled in a descriptive manner. Descriptive statistics (frequency table) and histogram will be used to summarize toxicity.
Measured: Up to 30 days post treatment
Incidence of hospitalization related to IIC
Analysis will be performed in all-treated population, defined as any subject enrolled into the study that received at least 3 days of VSL#3 and anti-PD-1/PD-L1. The statistical analyses will be handled in a descriptive manner. Descriptive statistics (frequency table) and histogram will be used to summarize clinical outcomes related to IIC.
Measured: Up to 14 weeks
Incidence of treatment delays related to IIC
Analysis will be performed in all-treated population, defined as any subject enrolled into the study that received at least 3 days of VSL#3 and anti-PD-1/PD-L1. The statistical analyses will be handled in a descriptive manner. Descriptive statistics (frequency table) and histogram will be used to summarize clinical outcomes related to IIC.
Measured: Up to 14 weeks
Incidence of administration of immunosuppressants related to IIC
Analysis will be performed in all-treated population, defined as any subject enrolled into the study that received at least 3 days of VSL#3 and anti-PD-1/PD-L1. The statistical analyses will be handled in a descriptive manner. Descriptive statistics (frequency table) and histogram will be used to summarize clinical outcomes related to IIC.
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start31 Jul 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Why it stopped: Change in funding status
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saranya Chumsri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508034
- Sponsor's protocol ID
- MC210304
- Other IDs
- NCI-2024-05551, 21-012363, MC210304
- Status last verified
- Jan 2026
- First submitted
- 12 Jul 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis
- ClinicalTrials.gov ID
- NCT06508034
- Acronym / sponsor ID
- MC210304
- Conditions
- Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Change in funding status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical trial tests the use of over-the-counter probiotics VSL#3® 450B in patients receiving immunotherapy. Immunotherapy with monoclonal antibodies, helps the body's immune system attack tumor cells, and interferes with the ability of tumor cells to grow and spread. Immunotherapy can also cause an unfortunate side effect of inflammation of the colon and diarrhea, also known as immune checkpoint inhibitor induced colitis. Immune checkpoint inhibitor induced colitis can occur in up to 45% of patients receiving immunotherapy. Taking probiotics VSL#3® 450B may reduce the chances of developing immune checkpoint inhibitor induced colitis in patients receiving immunotherapy.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the incidence of immune checkpoint inhibitors (ICI)-induced colitis (IIC) in patients with solid malignancies receiving over-the-counter multi-strain probiotic blend and ICIs in both cohorts: (1) anti-Cytotoxic T lymphocyte-associated protein-4 (CTLA-4) +/- anti-programmed cell death-1 (PD-1)/programmed cell death-1 ligand 1 (PD-L1), and (2) anti-PD-1/PD-L1 +/- chemo.
SECONDARY OBJECTIVES:
- To evaluate the safety of multi-strain probiotic blend in cancer patients receiving ICIs.
II. To evaluate the clinical outcomes related to IIC, including the incidence of IIC, hospitalization, treatment delays, and administration of immunosuppressants.
EXPLORATORY OBJECTIVES:
- To evaluate changes in gut microbiome with ICIs and multi-strain probiotic blend.
II. To evaluate changes in immune response with ICIs and multi-strain probiotic blend.
OUTLINE:
Patients receive VSL#3® 450B (live freeze-dried lactic acid bacteria probiotic) orally (PO) once daily (QD) at least 3 days prior or 1-2 weeks prior to starting standard care ICIs or receiving the next cycle of ICIs and then continue for 12 weeks. Patients also undergo stool and blood sample collections on study.
After completion of study treatment, patients are followed up at 30 days and 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (VSL#3® 450B) | Experimental | Procedure: Biospecimen Collection, Dietary Supplement: Live Freeze-Dried Lactic Acid Bacteria Probiotic, Other: Questionnaire AdministrationPatients receive VSL#3® 450B (live freeze-dried lactic acid bacteria probiotic) PO QD at least 3 days prior or 1-2 weeks prior to starting standard care or receiving the next cycle of ICIs and then continue for 12 weeks. Patients also undergo stool and blood sample collections on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Histologically confirmed solid malignancy
- Will be starting on ICIs or have started ≤ 2 cycles of ICIs
- Absolute neutrophil count (ANC) ≥ 1000/mm^3
Key exclusion criteria (14 listed)
- Requires prolonged systemic antibiotic therapy for other condition and recent systemic antibiotic within the past 2 weeks
- Fecal microbiota transplant (FMT) within the past 6 months
- FMT with an associated serious adverse event related to the FMT product or procedure
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of over-the-counter probiotics
- Immunocompromised patients including patients known to be HIV positive or those on chronic steroids > 20 mg prednisone a day or prednisone-equivalent Note: Must be off systemic steroids at least 90 days prior to enrollment. However, topical steroids, inhalants or steroid eye drops are permitted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo stool and blood sample collection | Procedure or surgery | Treatment (VSL#3® 450B) |
| Live Freeze-Dried Lactic Acid Bacteria ProbioticAlso: VSL#3, VSL3Given PO | Dietary supplement | Treatment (VSL#3® 450B) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (VSL#3® 450B) |
Primary outcome
Incidence of immune checkpoint inhibitors (ICI)-induced colitis (IIC) with VSL#3 and ICIs
Time frame: Up to 14 weeks
Will be evaluated in patients with solid malignancies in 2 cohorts, including 1) anti-CTLA4 ± anti-PD-1/PD-L1, 2) anti-PD-1/PD-L1 ± chemotherapy respectively. Analysis will be performed in all-treated population, defined as any subject enrolled into the study that received at least 3 days of VSL#3 and anti-PD-1/PD-L1. The statistical analyses will be handled in a descriptive manner. Will be estimated by the number of patients who had IIC divided by the total number of evaluable patients. Two-sided 90% exact confidence intervals for the true incidence rate will be calculated according to the approach of Clopper and Pearson.
4 secondary outcomes
Incidence of adverse events
Time frame: Up to 30 days post treatment
Incidence of hospitalization related to IIC
Time frame: Up to 14 weeks
Incidence of treatment delays related to IIC
Time frame: Up to 14 weeks
Incidence of administration of immunosuppressants related to IIC
Time frame: Up to 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saranya Chumsri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Live Freeze-Dried Lactic Acid Bacteria Probiotic and Questionnaire Administration in people with Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of immune checkpoint inhibitors (ICI)-induced colitis (IIC) with VSL#3 and ICIs (time frame: Up to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.