About this trial
This trial looks at a product called NBT-NM108 that may help patients with colon cancer. It focuses on whether this drink can reduce diarrhea caused by chemotherapy. Diarrhea is a common issue with the medicine irinotecan, which is used to treat colon cancer. The hope is that NBT-NM108 can make it easier for patients to handle their treatment by improving gut health and reducing diarrhea symptoms.
The trial's ID number is NCT05296681. This is a Phase 2 trial, which means it is looking at how well the treatment works and its safety. It is regulated by the FDA and aims to include about 42 participants.
Who can join
Men and women aged 18 and older can join. They must have colon cancer that has spread and be starting a specific type of chemotherapy. Some health conditions may prevent someone from joining, like severe diarrhea or certain gastrointestinal diseases. The trial team will confirm who is eligible to participate.
Conditions
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
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants are randomly placed into two groups. One group will drink NBT-NM108 four times a day for 56 days, starting before chemotherapy. The other group will receive standard chemotherapy without the special drink. Everyone will receive irinotecan-based chemotherapy as part of their treatment.
Where
This trial is running at 10 locations in the United States. All of them are currently recruiting.
Community Medical Center
Toms River, New Jersey
Cooperman Barnabas Medical Center
Livingston, New Jersey
Monmouth Medical Center
Lakewood, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey
Robert Wood Johnson University Hospital
New Brunswick, New Jersey
Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey
Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey
The first 8 of 10 sites are listed here. The registry record has the full list.