Using probiotics to prevent colitis in patients receiving immunotherapy
Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis
This study is testing if taking a probiotic called VSL#3® can help prevent colitis in patients with solid tumors who are receiving immunotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | Ipilimumab, pembrolizumab, nivolumab, cemiplimab, atezolizumab, avelumab, durvalumab, chemotherapy, prednisone, immunotherapy |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06508034 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the probiotic VSL#3® 450B in preventing immune checkpoint inhibitor-induced colitis in patients with solid tumors undergoing immunotherapy. Participants will take the probiotic daily for 12 weeks, starting 1-2 weeks before their immunotherapy treatment. The study aims to assess the incidence of colitis, safety of the probiotic, and its impact on gut microbiome and immune response. Patients will be monitored through stool and blood sample collections and follow-up visits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed solid malignancies who are about to start immunotherapy.
Not a fit: Patients who are not starting immunotherapy or have conditions that contraindicate the use of probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of colitis in patients undergoing immunotherapy, improving their treatment experience and outcomes.
How similar studies have performed: While the use of probiotics in cancer care is an emerging field, this specific approach has not been extensively tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Saranya Chumsri, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.