NCT07319364

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

An Observational, Real-World Study Evaluating Fecal Microbiota Transplantation for the Prevention/Reduction of Chemotherapy/Targeted Therapy-Induced Gastrointestinal Symptoms in Patients With Gastrointestinal Cancers.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: China