Could a common antibiotic help fight colorectal cancer?
NCT ID NCT05748145
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the antibiotic metronidazole can lower the amount of a specific bacteria (Fusobacterium nucleatum) in colorectal cancer tumors. About 40 adults with untreated colorectal cancer will take metronidazole before surgery. Researchers will compare bacteria levels in tumor samples taken before and after treatment to see if the antibiotic helps control the disease.
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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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Dec 2026
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: * Written informed consent according to ICH/GCP regulations before registration. * Age ≥ 18 years old * Untreated, primary colorectal adenocarcinoma (\> 15 cm from the anal verge) * Colonoscopy with endoscopic biopsy for disease confirmation and correlative studies. * Candidates for surgical resection prior to administration of any therapy. Exclusion Criteria: * Insufficient material on the tissue biopsy to be left in the archives of the Cantonal Institute of Pathology for further evaluations/analyses * Known prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives * Oral or parenteral antibiotic therapy within the six weeks prior to enrolment * Emergency surgery (planned within less than 14 days), where no opportunity to administer preoperative oral antibiotics exists * Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervices uteri * Any previous anticancer treatment prior resection * Women who are pregnant or breast feeding * Fertile women or men who do not use safe contraception during the study period * Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.), * Inability to consent and follow the procedures of the study e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment, affect patient compliance or place the patient at high risk from treatment-related complications
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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
1 site. 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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Oncology Institute of Southern Switzerland
RECRUITINGBellinzona, Canton Ticino, 6500, Switzerland
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