NCT05296681RecruitingPhase 2
Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 16 Mar 2022
- Start date
- 3 May 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Howard S. Hochster, MD
- Diseases
- Colorectal cancer
- NCT number
- NCT05296681
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- From 3 May 2022 to the primary completion date, Dec 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current antibiotic therapy
- 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.
Other illness
- 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 ulcerative colitis, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea.
Other
- Grade two diarrhea or greater (4-6 movements per day over baseline)
- Inability to take oral supplements
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Robert Wood Johnson University Hospital, Hamilton Coordinator of this site? Confirm its status | Hamilton | United States | Recruiting |
| RWJBarnabas Health - Monmouth Medical Center Southern Campus Coordinator of this site? Confirm its status | Lakewood | United States | Recruiting |
| Monmouth Medical Center Coordinator of this site? Confirm its status | Lakewood | United States | Recruiting |
| Cooperman Barnabas Medical Center Coordinator of this site? Confirm its status | Livingston | United States | Recruiting |
| The Cancer Center Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Newark Beth Israel Medical Center Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Robert Wood Johnson University Hospital Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Robert Wood Johnson University Hospital Somerset Coordinator of this site? Confirm its status | Somerville | United States | Recruiting |
| Community Medical Center Coordinator of this site? Confirm its status | Toms River | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.