Inactivated Bacteroides fragilis to help prevent chemotherapy-induced diarrhea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled study investigates the effect of an inactivated probiotic, Bacteroides fragilis SK10, on the incidence of diarrhea caused by chemotherapy. Participants are adults with advanced colorectal cancer on FOLFIRI or breast cancer patients treated with neratinib. The intervention compares SK10 injections with placebo to see if it reduces CID and to explore potential mechanisms. Eligibility includes adults with cancer, good performance status, and plans for the specified treatments, with standard safety and follow-up procedures. The study aims to clarify safety and potential benefit in a real-world oncology setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shenzhen Hospital, Southern Medical University
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Zhou
• Email: zhw811807859@126.com
• Phone: 18688489622

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Non-invasive brain stimulation to help chemotherapy-induced nerve problems in cancer survivors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.