OncoMatch/Clinical Trials/NCT05296681
Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
Is NCT05296681 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies NBT-NM108 for metastatic colon carcinoma.
Treatment: NBT-NM108 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: UGT1A1 wild-type
Disease stage
Required: Stage IV, IVA, IVB, IVC
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: irinotecan-based chemotherapy (irinotecan) — second-line or later
Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w
Lab requirements
Blood counts
Absolute Neutrophil Count (ANC) >1500/uL
Kidney function
Creatinine < 1.5 x Upper Limit of Normal (ULN)
Liver function
Transaminases < 5x ULN; Bilirubin < 1.5 x ULN; Albumin > 3.0 g/dL
Lab values as acceptable for trials: Absolute Neutrophil Count( ANC) >1500/uL; Creatinine < 1.5 x Upper Limit of Normal (ULN); Transaminases < 5x ULN; Bilirubin < 1.5 x ULN; Albumin > 3.0 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Robert Wood Johnson University Hospital, Hamilton · Hamilton, New Jersey
- Monmouth Medical Center · Lakewood, New Jersey
- RWJBarnabas Health - Monmouth Medical Center Southern Campus · Lakewood, New Jersey
- Cooperman Barnabas Medical Center · Livingston, New Jersey
- Robert Wood Johnson University Hospital · New Brunswick, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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