Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

Description

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

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

Study Overview

Study Details

Study overview

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.

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

Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

Condition
Metastatic Colon Carcinoma
Intervention / Treatment

-

Contacts and Locations

Hamilton

Robert Wood Johnson University Hospital, Hamilton, Hamilton, New Jersey, United States, 08690

Lakewood

Monmouth Medical Center, Lakewood, New Jersey, United States, 08701

Lakewood

RWJBarnabas Health - Monmouth Medical Center Southern Campus, Lakewood, New Jersey, United States, 08701

Livingston

Cooperman Barnabas Medical Center, Livingston, New Jersey, United States, 07039

New Brunswick

Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States, 08901

New Brunswick

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States, 08903

Newark

The Cancer Center, Newark, New Jersey, United States, 07103

Newark

Newark Beth Israel Medical Center, Newark, New Jersey, United States, 07112

Somerville

Robert Wood Johnson University Hospital, Somerset, Somerville, New Jersey, United States, 08876

Toms River

Community Medical Center, Toms River, New Jersey, United States, 08753

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Howard S. Hochster, MD,

    Howard S Hochster, MD, PRINCIPAL_INVESTIGATOR, Rutgers University

    Study Record Dates

    2025-07-01