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

NCT06508034 | Suspended DMC

• 3 other identifiers: MC210304NCI-2024-0555121-012363
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 14 weeks

Secondary Outcomes (4)

• Incidence of adverse events

  Up to 30 days post treatment

• Incidence of hospitalization related to IIC

  Up to 14 weeks

• Incidence of treatment delays related to IIC

  Up to 14 weeks

• Incidence of administration of immunosuppressants related to IIC

  Up to 14 weeks

Study Arms (1)

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.

Procedure: Biospecimen Collection; Dietary Supplement: Live Freeze-Dried Lactic Acid Bacteria Probiotic; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo stool and blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (VSL#3® 450B)

Live Freeze-Dried Lactic Acid Bacteria Probiotic DIETARY_SUPPLEMENT

Given PO

Also known as: VSL#3, VSL3

Treatment (VSL#3® 450B)

Questionnaire Administration OTHER

Ancillary studies

Treatment (VSL#3® 450B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Saranya Chumsri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)