RecruitingPhase 2NCT05296681

Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

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


Sponsor

Howard S. Hochster, MD

Enrollment

42 participants

Start Date

May 3, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a probiotic (beneficial bacteria) supplement can improve the health of gut bacteria and reduce the severe diarrhea that commonly occurs with irinotecan chemotherapy in people with metastatic colon cancer. **You may be eligible if...** - You have been diagnosed with metastatic colon cancer confirmed by biopsy - You are scheduled to receive irinotecan-based chemotherapy (second-line or later) - Your overall health is good (performance status 0–1) - Your blood counts, kidney, and liver function are within acceptable ranges - If you previously received irinotecan, you have been off it for at least 3 months and your bowel habits have returned to normal **You may NOT be eligible if...** - You currently have moderate to severe diarrhea (more than 4–6 extra bowel movements per day above your normal) - You are unable to take oral supplements - You are currently on antibiotic therapy - You have a known genetic variant that affects irinotecan metabolism (UGT1A1) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNBT-NM108

Patients receive irinotecan-based chemotherapy per standard of care.


Locations(10)

Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey, United States

Monmouth Medical Center

Lakewood, New Jersey, United States

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Lakewood, New Jersey, United States

Cooperman Barnabas Medical Center

Livingston, New Jersey, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

The Cancer Center

Newark, New Jersey, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Robert Wood Johnson University Hospital, Somerset

Somerville, New Jersey, United States

Community Medical Center

Toms River, New Jersey, United States

View Full Details on ClinicalTrials.gov

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NCT05296681


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