A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery
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- STATUS
- Recruiting
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- End date
- Sep 1, 2023
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- participants needed
- 42
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- sponsor
- Howard S. Hochster, MD
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.
Description
PRIMARY ENDPOINT:
Dose Intensity of Irinotecan administered (mg/m2/week)
SECONDARY ENDPOINTS:
- Reduction in % Patients Needing Dose Modification for Diarrhea
- Toxicity Grade of diarrhea
- Response Rate
- Time to Progression-free survival
EXPLORATORY ENDPOINTS:
- 16S rRNA gene sequencing to reveal changes of the gut microbiota including institution of foundation guilds and restoration of healthy microbiome
- Short chain fatty acids analysis (promotion of acetic and butyric acid production)
- Markers for gut inflammation such as fecal lipocalin 2
- Gut barrier function test to see if the restoration of healthier gut microbiota would improve gut barrier function.
Details
| Condition | 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 |
|---|---|
| Treatment | NBT-NM108 |
| Clinical Study Identifier | NCT05296681 |
| Sponsor | Howard S. Hochster, MD |
| Last Modified on | 23 October 2022 |
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