Actively Recruiting
Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
Led by Howard S. Hochster, MD · Updated on 2026-01-06
42
Participants Needed
10
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-proven metastatic colon cancer
- Candidate for second-line or later irinotecan-based chemotherapy starting at 180 mg/m2 every 2 weeks
- Prior irinotecan allowed if off for at least 3 months and stools returned to normal consistency
- Performance status 0-1
- Lab values: Absolute Neutrophil Count >1500/uL; Creatinine <1.5x upper limit of normal; Transaminases <5x upper limit of normal; Bilirubin <1.5x upper limit of normal; Albumin >3.0 g/dL
- No known UGTA1A* genotype
You will not qualify if you...
- Grade two or higher diarrhea (4-6 bowel movements per day over baseline)
- Unable to take oral supplements
- Current antibiotic therapy
- Baseline grade 3-4 diarrhea
- Active infections causing diarrhea unless treated with normal stools for at least 3 months
- History of gastrointestinal infections or diseases causing diarrhea such as ulcerative colitis, Crohn's disease, celiac sprue, chronic pancreatitis, malabsorption, or other related conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States, 08690
Actively Recruiting
2
Monmouth Medical Center
Lakewood, New Jersey, United States, 08701
Actively Recruiting
3
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States, 08701
Actively Recruiting
4
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
5
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
6
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
7
The Cancer Center
Newark, New Jersey, United States, 07103
Actively Recruiting
8
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
9
Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey, United States, 08876
Actively Recruiting
10
Community Medical Center
Toms River, New Jersey, United States, 08753
Actively Recruiting
Research Team
H
Howard S Hochster, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here