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Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
NCT05296681 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG NBT-NM108
Study Locations (10)
New Jersey
- Robert Wood Johnson University Hospital, Hamilton — Hamilton
- Monmouth Medical Center — Lakewood
- RWJBarnabas Health - Monmouth Medical Center Southern Campus — Lakewood
- Cooperman Barnabas Medical Center — Livingston
- Robert Wood Johnson University Hospital — New Brunswick
- Rutgers Cancer Institute of New Jersey — New Brunswick
- The Cancer Center — Newark
- Newark Beth Israel Medical Center — Newark
- Robert Wood Johnson University Hospital, Somerset — Somerville
- Community Medical Center — Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-05-03 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05296681
The ClinicalTrials.gov registry entry for NCT05296681 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Howard S. Hochster, MD, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Metastatic Colon Carcinoma appearing as the primary indexed condition, and to 1 intervention — of which NBT-NM108 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05296681 reports 10 study locations spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05296681 about?
NCT05296681 is a clinical study titled "Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery". 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...
What is the current status of trial NCT05296681?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2022-05-03. Estimated completion is 2027-06-01.
What conditions does trial NCT05296681 study?
This clinical trial studies the following 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05296681?
The interventions under investigation include: NBT-NM108 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05296681?
This trial is sponsored by Howard S. Hochster, MD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05296681 being conducted?
This trial has 10 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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