drugset / Trial / NCT05296681

Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

NCT05296681 ↗

Phase 2 Recruiting 42 enrolled Howard S. Hochster, MD
RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial tests whether NBT-NM108 works in reducing chemotherapy-induced diarrhea in patients with colon cancer that has spread to other places in the body (metastatic). Irinotecan is one of the most used medicine for colon cancer, but it leads to diarrhea in most patients receiving it and among some of them, severe diarrhea can occur. NBT-NM108 is a high dietary fiber formula that is developed based on research findings that have shown that high fiber diets can help maintain healthy bacteria in the gut and improve gut function. Giving NBT-NM108 to patients with colon cancer receiving chemotherapy may help relieve or lessen diarrhea symptoms and lead to improved tolerance of the chemotherapy drug, irinotecan.

Timeline

Start
2022-05-03
Primary completion
2026-12
Completion
2027-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject NBT-NM108 Other / unclassified — Oral