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Recruiting NCT07319364

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fecal microbiota transplantation (FMT).
Who it may be relevant to
Registry conditions: Fecal Microbiota Transplantation (FMT), Gastrointestinal Neoplasms, Antineoplastic Agents, Drug-related Side Effects and Adverse Reactions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Incidence and improvement rate of chemotherapy/targeted therapy-induced gastrointestinal symptoms in patients with gastrointestinal cancers [Time frame: At 8 weeks post-FMT]
Secondary outcome measures (3)
  • The incidence and improvement rate of gastrointestinal (GI) symptoms in patients with gastrointestinal cancers [Time frame: At 4 weeks post-FMT]
  • Changes in Gut Microbiota Diversity Indices [Time frame: At 4, 8 weeks post-FMT]
  • Correlation Between Changes in Gut Microbiota Abundance and Improvement of Gastrointestinal Symptoms [Time frame: At 8 weeks post-FMT]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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;
  • Uncontrolled or severe infections;
  • Known history of psychotropic substance abuse, alcoholism, and drug abuse;
  • Patients with severe infections complicated with septicemia or sepsis;
  • Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;
  • Patients with active viral infections;
  • 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);
  • Patients with gastrointestinal perforation and/or fistula;
  • Other conditions deemed unsuitable for enrollment by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital Zhejiang University School of Medicine — Zhejiang

Identifiers

NCT: NCT07319364 · 2025-1390

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗