Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-27 @ 8:52 AM
Study NCT ID:
NCT06508034
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2024-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics for the Prevention of Immunotherapy Induced Colitis in Patients Receiving Immunotherapy
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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:
I. 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:
I. 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:
I. 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.
I. 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:
I. 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:
I. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: