NCT05296681 Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
| NCT ID | NCT05296681 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Howard S. Hochster, MD |
| Condition | Metastatic Colon Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2022-05-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2022-05-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria * 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 Exclusion Criteria * 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.
Contact & Investigator
Howard S Hochster, MD
PRINCIPAL INVESTIGATOR
Rutgers University
Frequently Asked Questions
Who can join the NCT05296681 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Colon Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05296681 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05296681 currently recruiting?
Yes, NCT05296681 is actively recruiting participants. Contact the research team at howard.hochster@rutgers.edu for enrollment information.
Where is the NCT05296681 trial being conducted?
This trial is being conducted at Hamilton, United States, Lakewood, United States, Lakewood, United States, Livingston, United States and 6 additional locations.
Who is sponsoring the NCT05296681 clinical trial?
NCT05296681 is sponsored by Howard S. Hochster, MD. The principal investigator is Howard S Hochster, MD at Rutgers University. The trial plans to enroll 42 participants.