SUSPENDED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis

Quick Facts

Study Start:2024-07-31

Study Completion:2027-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT06508034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * Willing to return to enrolling institution for all study visits (blood draws, etc)	* 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

Inclusion Criteria

Exclusion Criteria

* 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
* Willing to return to enrolling institution for all study visits (blood draws, etc)

* 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

Contacts and Locations

Principal Investigator

Saranya Chumsri, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Saranya Chumsri, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-31

Study Completion Date2027-08-30

Study Record Updates

Study Start Date2024-07-31

Study Completion Date2027-08-30

Terms related to this study

Additional Relevant MeSH Terms

Malignant Solid Neoplasm