Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

Recruiting now · Phase 2

Conditions studied: Metastatic Colon Carcinoma, Stage IV Colon Cancer AJCC v8, Stage IVA Colon Cancer AJCC v8, Stage IVB Colon Cancer AJCC v8, Stage IVC Colon Cancer AJCC v8

In brief

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.

Key facts

Study ID

NCT05296681

Run by

Howard S. Hochster, MD

People needed

42

Starts

2022-05-03

Expected to finish

2027-06-01

Last updated by the study team

2026-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 baseline consistency.
• Performance Status (PS) 0-1
• 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
• No known UGTA1A* genotype

You may not qualify if…

• Grade two diarrhea or greater (4-6 movements per day over baseline)
• Inability to take oral supplements
• Current antibiotic therapy
• Baseline grade 3-4 diarrhea Participants with grade two diarrhea should undergo stool evaluation with stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea. They will be eligible if this evaluation shows no infection.
• History of the following infections and/or disease which could lead to diarrhea:
• History of prior positive gastrointestinal biopsy, gastrointestinal culture, or stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia, Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea unless fully treated with at least three months normal stool.
• History of ulcerative colitis, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea.

Where it is running

• Robert Wood Johnson University Hospital, Hamilton — Hamilton, New Jersey, United States (enrolling)
• Monmouth Medical Center — Lakewood, New Jersey, United States (enrolling)
• RWJBarnabas Health - Monmouth Medical Center Southern Campus — Lakewood, New Jersey, United States (enrolling)
• Cooperman Barnabas Medical Center — Livingston, New Jersey, United States (enrolling)
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (enrolling)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
• The Cancer Center — Newark, New Jersey, United States (enrolling)
• Newark Beth Israel Medical Center — Newark, New Jersey, United States (enrolling)
• Robert Wood Johnson University Hospital, Somerset — Somerville, New Jersey, United States (enrolling)
• Community Medical Center — Toms River, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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