Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508034
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Probiotics for the Prevention of Immunotherapy Induced Colitis in Patients Receiving Immunotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 VSL3 450B in patients receiving immunotherapy Immunotherapy with monoclonal antibodies helps the bodys 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 VSL3 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-1programmed cell death-1 ligand 1 PD-L1 and 2 anti-PD-1PD-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 VSL3 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 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-1programmed cell death-1 ligand 1 PD-L1 and 2 anti-PD-1PD-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 VSL3 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 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None