Probiotics for the Prevention of Immunotherapy Induced Colitis in Patients Receiving Immunotherapy
Public ClinicalTrials.gov record NCT06508034. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06508034
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Interventions
- Biospecimen Collection Procedure
- Live Freeze-Dried Lactic Acid Bacteria Probiotic Dietary Supplement
- Questionnaire Administration Other
Procedure · Dietary Supplement · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 30, 2024
- Primary completion
- Aug 29, 2027
- Completion
- Aug 29, 2027
- Last update posted
- Jan 20, 2026
2024 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06508034, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 20, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06508034 live on ClinicalTrials.gov.