RecruitingPhase 2NCT06728072

Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer

Pilot Study Evaluating Microbiome Modulation Therapy (MBMT) With Ciprofloxacin, Metronidazole, and Aspirin in Addition to Standard of Care Chemotherapy in Patients Undergoing First-Line Therapy for Metastatic Colorectal Cancer


Sponsor

Virginia Commonwealth University

Enrollment

97 participants

Start Date

Mar 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a 2-arm, noncomparative phase 2 trial designed to evaluate treatment outcomes with or without the addition of ciprofloxacin, metronidazole, and aspirin to first-line chemotherapy for patients with stage IV colorectal cancer (CRC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a specific combination of antibiotics (to modify gut bacteria) to standard chemotherapy improves outcomes for people with stage IV (metastatic) colorectal cancer. Research suggests certain gut bacteria may affect how well chemotherapy works. **You may be eligible if...** - You have been diagnosed with stage IV (advanced, spread) colorectal cancer - You have measurable disease on scans - You are about to start first-line chemotherapy with a standard 5-fluorouracil (5FU)-based regimen - Your blood counts and organ function are within acceptable ranges - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have had your entire colon removed (total colectomy) - You have Cockayne Syndrome - You are taking certain medications that interact with the study antibiotics (disulfiram, tizanidine, theophylline, or high-dose methotrexate) and cannot stop them - You are allergic to ciprofloxacin, metronidazole, or aspirin - You received a full course of antibiotics in the 30 days before starting chemotherapy - You have an abnormal heart rhythm (prolonged QTc interval) on an ECG - You have a condition that affects your ability to absorb or swallow medications 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGStandard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin

Metronidazole, ciprofloxacin, aspirin is initiated Cycle 1 Day 1 of chemotherapy. May be initiated any time from 7 days before Cycle 1 Day 1 up to and including Cycle 1 Day 3


Locations(2)

Virginia Cancer Institute (VCI)

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06728072


Related Trials