Probiotics for the Prevention of Immunotherapy Induced Colitis in Patients Receiving Immunotherapy

Trial Title: Probiotics for the Prevention of Immunotherapy Induced Colitis in Patients Receiving Immunotherapy

NCT ID: NCT06508034

Condition: Malignant Solid Neoplasm

Conditions: Official terms:
Colitis

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo stool and blood sample collection
Arm group label: Treatment (VSL#3® 450B)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Dietary Supplement
Intervention name: Live Freeze-Dried Lactic Acid Bacteria Probiotic
Description: Given PO
Arm group label: Treatment (VSL#3® 450B)

Other name: VSL#3

Other name: VSL3

Intervention type: Other
Intervention name: Questionnaire Administration
Description: Ancillary studies
Arm group label: Treatment (VSL#3® 450B)

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 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Male or female age ≥ 18 years - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 - Histologically confirmed solid malignancy - Will be starting on 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 - 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) Exclusion Criteria: - 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 - 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic in Florida

Address:
City: Jacksonville
Zip: 32224-9980
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Referral Office

Phone: 855-776-0015
Email: mayocliniccancerstudies@mayo.edu

Investigator:
Last name: Saranya Chumsri, M.D.
Email: Principal Investigator

Start date: July 31, 2024

Completion date: August 30, 2027

Lead sponsor:
Agency: Mayo Clinic
Agency class: Other

Source: Mayo Clinic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06508034
https://www.mayo.edu/research/clinical-trials