MedTrace Logo

Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

NCT05296681 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-06

No results posted yet for this 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

  • 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

Interventions

DRUG

NBT-NM108

Patients receive irinotecan-based chemotherapy per standard of care.

Sponsors & Collaborators

  • Howard S. Hochster, MD

    lead OTHER

Principal Investigators

  • Howard S Hochster, MD · Rutgers University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2026-12-31
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05296681 on ClinicalTrials.gov