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

NCT ID: NCT07319364

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-01

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental Group

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.

Group Type: EXPERIMENTAL

Fecal microbiota transplantation (FMT)

Intervention Type: BIOLOGICAL

Building upon the existing treatment regimen, starting from the fourth cycle, one FMT treatment was administered 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 intestinal bacteria 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.

Interventions

Fecal microbiota transplantation (FMT)

Building upon the existing treatment regimen, starting from the fourth cycle, one FMT treatment was administered 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 intestinal bacteria 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Chemotherapy; Targeted Therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, Hangzhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Da Wang

Role: CONTACT

wangda0618@zju.edu.cn

86-0571-87784720

Facility Contacts

Da Wang

Role: primary

wangda0618@zju.edu.cn

8613819108162

Other Identifiers

2025-1390

Identifier Type: -

Identifier Source: org_study_id