Can a dead bug stop chemo side effects? new trial aims to find out.
NCT ID NCT07309315
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking an inactivated (killed) form of the bacterium Bacteroides fragilis can prevent diarrhea caused by chemotherapy. The trial will enroll 200 cancer patients about to start chemotherapy regimens known to cause diarrhea. Participants will receive either the inactivated bacterium or a placebo, and researchers will track how many develop diarrhea and its severity.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- 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: 1. Voluntarily sign the informed consent form, be able to comply with the protocol and have the capacity to complete relevant procedures. 2. Aged ≥ 18 years old (based on the date of signing the ICF), regardless of gender. 3. Patients with malignant tumors confirmed by pathology or cytology. 4. Patients scheduled to receive the following initial treatments at the standard dose specified in the protocol: * Cohort 1: Patients with advanced colorectal cancer receiving the FOLFIRI regimen (irinotecan + fluorouracil + leucovorin); * Cohort 2: Patients with breast cancer receiving neratinib treatment. 5. ECOG performance status score of 0-1 at the start of the study. 6. Expected survival time ≥ 12 weeks. 7. Subjects of childbearing potential (including males and females) agree to adopt effective contraceptive measures approved by the investigators (e.g., intrauterine device, contraceptive pills or condoms) during the trial and within 3 months after the trial ends. Female subjects of childbearing potential must have a negative result in serum human chorionic gonadotropin (hCG) test. Exclusion Criteria: 1. History of altered bowel habits or abnormal stool characteristics prior to screening that, in the investigator's opinion, would preclude subsequent efficacy evaluation; or use of laxatives within 7 days prior to randomization; or use of antidiarrheal agents within 48 hours prior to randomization. 2. Complicated with diseases causing diarrhea, including but not limited to inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease), suspected or confirmed infectious diarrhea, irritable bowel syndrome, celiac disease, etc. 3. Receipt of any chemotherapeutic agents or PD-1 antibodies other than the chemotherapy/treatment regimen specified in the protocol during the trial. 4. Concurrent abdominopelvic radiotherapy during the trial period; or unresolved radiotherapy-induced enteritis caused by previous abdominopelvic radiotherapy. 5. Medical history of chronic use of laxatives (≥ 30 non-consecutive days). 6. Need for antibiotic treatment during the trial or long-term use of antibiotics prior to randomization. 7. Patients with stomas, including temporary stomas that have not been closed or patients whose bowel function has not recovered after stoma closure. 8. Presence of unhealed surgical wounds, ulcers or fractures. 9. Known history of human immunodeficiency virus (HIV) infection (positive HIV antibody test). 10. History of allergy or suspected allergy to antidiarrheal drugs (e.g., loperamide and its components). 11. Suspected or confirmed history of alcohol or drug abuse. 12. Pregnant or lactating women. 13. Concurrent participation in other clinical trials. 14. Other conditions deemed inappropriate for study participation by the investigator.
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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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Shenzhen Hospital, Southern Medical University
RECRUITINGShenzhen, Guangdong, 518005, China
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Other studies related to the condition(s) this trial covers.
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- Mind and body: does resilience leave a molecular mark in breast cancer?
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- Bacteria inside tumors may hold the key to breast cancer treatment
- Can a newer drug ease the bone pain of chemotherapy support?