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

NCT06508034 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-01-21

No results posted yet for this study

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo stool and blood sample collection

DIETARY_SUPPLEMENT

Live Freeze-Dried Lactic Acid Bacteria Probiotic

Given PO

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

Principal Investigators

  • Saranya Chumsri, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2027-08-30
Completion
2027-08-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06508034 on ClinicalTrials.gov