A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects

Zhejiang University

Status and phase: Enrolling; Phase 1

Conditions: Antineoplastic Agents; Fecal Microbiota Transplantation (FMT); Drug-related Side Effects and Adverse Reactions; Gastrointestinal Neoplasms

Treatments: Biological: Fecal microbiota transplantation (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07319364

2025-1390

Details and patient eligibility

About

The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy / targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years, gender not restricted;
2. Estimated survival time ≥ 3 months;
3. Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.;
4. TNM staging of cancer in patients is Stage IV;
5. Having undergone PD-1 or PD-L1 testing;
6. Planned to receive the 4th cycle of chemotherapy/targeted therapy;
7. Occurrence of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within 3 cycles of conventional chemotherapy/targeted therapy;
8. Patients are able and willing to sign the informed consent form and complete follow-up;
9. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
10. Use of oral/intravenous broad-spectrum antibiotics with caution within 3 days;
11. Patients are able to swallow capsules without chewing;
12. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
13. Laboratory test results during the screening period indicate that the subjects have sufficient organ function.

Exclusion criteria

1. Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or renal failure, and hepatic insufficiency/hepatic failure;
2. Uncontrolled or severe infections;
3. Known history of psychotropic substance abuse, alcoholism, and drug abuse;
4. Patients with severe infections complicated with septicemia or sepsis;
5. Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;
6. Patients with active viral infections;
7. Female subjects with a positive pregnancy test, lactating female subjects, and women of childbearing age who refuse to use contraceptive measures during the entire observation period (15 weeks);
8. Patients with gastrointestinal perforation and/or fistula;
9. Other conditions deemed unsuitable for enrollment by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Control Group

No Intervention group

Description:

Patients in the control group continued their original chemotherapy/targeted therapy regimen, with each treatment cycle lasting 3 weeks, for a total of 5 cycles. Treatment efficacy was assessed after every 2 cycles.

Experimental Group

Experimental group

Description:

Patients in the FMT group received treatment starting from the fourth cycle on top of their existing regimen. They underwent one FMT treatment within 3 days prior to chemotherapy/targeted therapy during the fourth, sixth, and eighth cycles (weeks 3, 9, and 15 after study initiation). Each transplant consisted of approximately 40g of donor gut microbiota encapsulated in capsules. The capsules were administered orally, typically at a dose of 2-3 capsules (1g/capsule) every 3-5 minutes, totaling 40 capsules per dose for a total of 120 capsules. Treatment cycles were conducted every 3 weeks, with therapeutic efficacy assessed after every 2 cycles.

Treatment:

Biological: Fecal microbiota transplantation (FMT)