Inactivated Bacteroides Fragilis for Prevention of Chemotherapy-Induced Diarrhea

NCT07309315 | Not Yet Recruiting

• 1 other identifier: SK10-IIT
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The incidence of chemotherapy-induced diarrhea (CID) is closely related to the types of anticancer drugs. Combination chemotherapy regimens such as fluorouracil derivatives and irinotecan, as well as tyrosine kinase inhibitors like neratinib, are associated with a high severity and incidence of diarrhea. These All antineoplastic agents can induce intestinal epithelial cell apoptosis, damage the intestinal mucosa, subsequently reduce the absorption surface area, and thereby lead to diarrhea. Recent literature has indicated that Bacteroides fragilis may be a candidate drug for the treatment and prevention of CID. This study intends to conduct a randomized controlled trial to determine the efficacy and mechanism of action of inactivated Bacteroides fragilis (SK10) in the prevention of chemotherapy-induced diarrhea (CID).

Conditions

Chemotherapy-induced Diarrhea

Outcome Measures

Primary Outcomes (1)

• Overall Incidence of Diarrhea

  Proportion of Patients with Any Grade of Diarrhea assessed by CTCAE v5.0

  4 weeks

Secondary Outcomes (12)

• Incidence of Grade ≥2 Diarrhea

  4 weeks

• Incidence of Grade ≥3 Diarrhea

  4 weeks

• Days of Diarrhea

  4 weeks

• Frequency of Diarrhea

  4 weeks

• Percentage and Days of Patients Receiving Antidiarrheal Treatment

  4 weeks

Other Outcomes (2)

• Change in Levels of Blood Inflammatory Cytokines Compared with Baseline

  4 weeks

• Change in Composition and Diversity of Fecal Flora Structure, and Change in Fecal Metabolomics

  4 weeks

Study Arms (4)

Arm 1

EXPERIMENTAL

Trial Group of Patients with Advanced Colorectal Cancer

Drug: Inactivated Bacteroides fragilis

Arm 2

PLACEBO COMPARATOR

Control Group of Patients with Advanced Colorectal Cancer

Drug: Placebo

Arm 3

EXPERIMENTAL

Trial Group of Patients with Breast Cancer

Drug: Inactivated Bacteroides fragilis

Arm 4

PLACEBO COMPARATOR

Control Group of Patients with Breast Cancer

Drug: Placebo

Interventions

Inactivated Bacteroides fragilis DRUG

Live Biotherapeutic Products

Also known as: SK10

Arm 1; Arm 3

Placebo DRUG

Placebo

Arm 2; Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form, be able to comply with the protocol and have the capacity to complete relevant procedures.
• Aged ≥ 18 years old (based on the date of signing the ICF), regardless of gender.
• Patients with malignant tumors confirmed by pathology or cytology.
• Patients scheduled to receive the following first-line 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.
• ECOG performance status score of 0-1 at the start of the study.
• Expected survival time ≥ 12 weeks.
• 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.

You may not qualify if:

• History of altered bowel habits or abnormal stool characteristics prior to screening; or use of laxatives within 7 days prior to randomization; or use of antidiarrheal agents within 48 hours prior to randomization.
• 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.
• Receipt of any chemotherapeutic agents, cetuximab or PD-1 antibodies other than the chemotherapy/treatment regimen specified in the protocol during the trial.
• Previous or concurrent abdominopelvic radiotherapy during the trial period.
• Medical history of chronic use of laxatives (≥ 30 non-consecutive days).
• Need for antibiotic treatment during the trial or long-term use of antibiotics prior to randomization.
• Patients with stomas (temporary stomas should be closed for at least 6 months prior to randomization).
• Presence of unhealed surgical wounds, ulcers or fractures.
• Known history of human immunodeficiency virus (HIV) infection (positive HIV antibody test).
• History of allergy or suspected allergy to antidiarrheal drugs (e.g., loperamide and its components).
• Suspected or confirmed history of alcohol or drug abuse.
• Pregnant or lactating women.
• Concurrent participation in other clinical trials.
• Other conditions deemed inappropriate for study participation by the investigator.

Sponsors & Collaborators

• Shenzhen Hospital of Southern Medical University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital Director

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 30, 2025
• Study Start: December 15, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share