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Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

Stage IV Colon Cancer AJCC v8 Clinical Trial

Official title:
A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery

Clinical Trial 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.

Clinical Trial Description

PRIMARY ENDPOINT: Dose Intensity of Irinotecan administered (mg/m2/week) SECONDARY ENDPOINTS: 1. Reduction in % Patients Needing Dose Modification for Diarrhea 2. Toxicity Grade of diarrhea 3. Response Rate 4. Time to Progression-free survival EXPLORATORY ENDPOINTS: 1. 16S rRNA gene sequencing to reveal changes of the gut microbiota including institution of foundation guilds and restoration of healthy microbiome 2. Short chain fatty acids analysis (promotion of acetic and butyric acid production) 3. Markers for gut inflammation such as fecal lipocalin 2 4. Gut barrier function test to see if the restoration of healthier gut microbiota would improve gut barrier function. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05296681
Study type Interventional
Source Rutgers, The State University of New Jersey
Contact Howard S Hochster, MD
Phone 732-235-2465
Email howard.hochster@rutgers.edu
Status Recruiting
Phase Phase 2
Start date May 3, 2022
Completion date July 1, 2025
View Details
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