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NCT05296681 · ClinicalTrials.gov registry record · Phase 2
Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
A Phase 2 study of Metastatic Colon Carcinoma and Stage IV Colon Cancer AJCC v8, sponsored by Howard S. Hochster, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 10
- Study locations
NCT05296681 is a Phase 2 study of Metastatic Colon Carcinoma and Stage IV Colon Cancer AJCC v8 that is actively recruiting participants, run by Howard S. Hochster, MD. The registered enrollment target is 42 participants, below the 262-participant average among 3 other Metastatic Colon Carcinoma trials with a reported enrollment target (84% lower). The trial reports 10 study locations across 1 state.
The verdict
NCT05296681, a Phase 2 study of Metastatic Colon Carcinoma and Stage IV Colon Cancer AJCC v8, is actively recruiting participants, sponsored by Howard S. Hochster, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 10
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 262-participant average among 3 other Metastatic Colon Carcinoma trials with a reported enrollment target (84% lower). The listed sponsor is Howard S. Hochster, MD, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT05296681 reports 10 study locations spanning 1 distinct geographic area - top geographies include New Jersey.
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.
What interventions are being tested in trial NCT05296681?
The interventions under investigation include: NBT-NM108 (DRUG).
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.
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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