Testing NBT-NM108 to Support Gut Health and Reduce Diarrhea During Irinotecan Chemotherapy for Advanced Colon Cancer

What this Trial Is About

Researchers are evaluating a dietary fiber formula called NBT-NM108 in patients with metastatic colon cancer receiving irinotecan-based chemotherapy. Irinotecan often causes diarrhea, which can be severe and affect treatment tolerance. This phase II trial aims to see if NBT-NM108 can reduce diarrhea symptoms by promoting a healthier gut microbiome, potentially improving patients ability to continue their chemotherapy. Participants are randomly assigned to one of two groups one group receives NBT-NM108 drinks four times daily before meals and two hours after dinner for 56 days, starting five days before chemotherapy begins. Both groups receive irinotecan-based chemotherapy as standard care. The study compares the dose intensity of irinotecan administered, diarrhea severity, treatment response, and progression-free survival between the groups. Additional analysis includes gut microbiota sequencing and tests for gut inflammation and barrier function. During the study, participants undergo assessments of treatment-related side effects and tumor response by imaging. Researchers monitor diarrhea toxicity, need for chemotherapy dose modifications, and microbiome changes. The main outcome is measured at eight weeks, with imaging done before chemotherapy and at six weeks after treatment starts. Participants are followed throughout the treatment period to evaluate safety, treatment tolerance, and microbiome effects.

Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery