Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

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 receivin

Trial Details

NCT ID
NCT05296681
Phase
PHASE2
Sponsor
Howard S. Hochster, MD
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • NBT-NM108
Locations (sample)
  • Hamilton, New Jersey, United States|40.20706,-74.08125
  • Lakewood, New Jersey, United States|40.09789,-74.21764
  • Lakewood, New Jersey, United States|40.09789,-74.21764
  • Livingston, New Jersey, United States|40.79593,-74.31487
  • New Brunswick, New Jersey, United States|40.48622,-74.45182

Key Eligibility Criteria

  • Biopsy proven and metastatic colon cancer
  • Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w.
  • Participants who have had prior irinotecan will be eligible if they are off irinotecan for at least three months and stools have returned to baseli…
  • Performance Status (PS) 0-1

For full eligibility, visit ClinicalTrials.gov.

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