Clinical trial · Interventional
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
NCT06728072CI-TRIAL-00122609recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| CRC | Colorectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- First line chemotherapy as directed. Standard of care chemotherapy treatment options include but are not limited to the following: * FOLFOX every 2 weeks * FOLFIRI every 2 weeks * FOLFOX + bevacizumab or panitumumab every 2 weeks * FOLFIRI + bevacizumab or panitumumab every 2 weeks * CAPEOX every 3 weeks * CAPEOX + bevacizumab or panitumumab every 3 weeks
- type
- EXPERIMENTAL
- label
- Metronidazole Ciprofloxacin and Aspirin Therapy
- description
- First line chemo therapy (standard of care) + Microbiome modulation therapy MBMT 500 mg metronidazole 3 times daily, 500 mg ciprofloxacin twice daily, and 81 mg aspirin once daily for 28 days
- interventionNames
- Drug: Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin
Primary outcomes (1)
- measure
- Best response by analysis using Response Evaluation Criteria in Solid Tumors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.