Gut bacteria hack: could antibiotics boost chemo for stage IV colon cancer?
NCT ID NCT06728072
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether adding two antibiotics (ciprofloxacin and metronidazole) plus aspirin to standard chemotherapy can improve outcomes for people with stage IV colorectal cancer. About 97 participants will receive either chemo alone or chemo plus the microbiome modulation therapy. The goal is to see if this combination increases tumor shrinkage and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ciprofloxacin, metronidazole, and aspirin
- What this could lead to
- If it works, this could point toward a way to make chemotherapy more effective for advanced colorectal cancer by targeting gut bacteria.
- What could go wrong
- This is a small, early-phase pilot study, so results may not apply broadly. Adding antibiotics and aspirin may cause side effects like digestive issues or bleeding risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 97 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jul 2035
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of stage IV colorectal cancer * Measurable disease by Response evaluation criteria in solid tumors (RECIST) 1.1 criteria * Planned first-line treatment with a 5FU-based doublet chemotherapy regimen for colon cancer, specifics of the regimen at the discretion of the treating physician Note: Patients who have received adjuvant therapy \>6 months prior are eligible * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 * Absolute neutrophil count (ANC) ≥1,500 cells/μL * Platelet count ≥100,000 cells/μL * Hemoglobin ≥8 g/dL Note: The use of transfusion or other intervention to achieve hemoglobin ≥8 g/dL is acceptable. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) Note: Patients with documented liver metastases: AST and ALT ≤5 × ULN * Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥40 mL/min using the Cockcroft-Gault equation: (140 - age) × body weight/plasma creatinine × 72 (× 0.85 if female) * Radiographically measurable disease by RECIST 1.1 * Nonpregnant and not actively breastfeeding * Sexually active patients of childbearing potential and their partners must agree to use medically acceptable form of contraception, per treating investigator, throughout the study Patients should continue to use medically acceptable methods of contraception after study treatment ends, following the guidance for their specific chemotherapy regimen. Childbearing potential excludes: Age \> 50 years and naturally amenorrhoeic for \> 1 year OR previous hysterectomy or bilateral salpingo-oophorectomy * Patients on a pre-existing daily aspirin regimen may participate in the study without interrupting this regimen. * Patients with a contraindication to aspirin may participate in the study. These patients will not be required to take aspirin as part of the study treatment. Exclusion Criteria: * Total colectomy * Diagnosed with Cockayne Syndrome * Using disulfiram, tizanidine, or theophylline and unable to stop taking these medications for the length of the microbiome modulation therapy * On methotrexate doses of 15 mg/week or more * History of allergic reaction to ciprofloxacin, metronidazole, or aspirin * Fuss course of antibiotics in the 30 days before chemotherapy start Note: Full course is defined as ≥5 doses with an intent to treat a defined infection. Use of antibiotics intended for prophylaxis at the time of surgery is allowed * Corrected QT interval (QTc) \>480 on baseline ECG * Diagnosed with a malabsorptive syndrome * Inability to swallow tablets
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Virginia Cancer Institute (VCI)
RECRUITINGRichmond, Virginia, 23229, United States
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Virginia Commonwealth University
RECRUITINGRichmond, Virginia, 23298, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to why some cancer treatments work better
- Burning the edges: a new way to stop colon polyps from coming back
- Missed Follow-Up colonoscopies: do they raise the risk of advanced growths?
- A 2.2 mm scope could spot cancerous tissue in minutes, not days
- The gatekeepers of tumors: scientists probe how blood vessels let immune cells in
- New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers