Fecal Microbiota Transplantation for Preventing Gastrointestinal Symptoms in Extrapulmonary Neuroendocrine Neoplasms: A Real-World Study

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Apr 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called fecal microbiota transplantation (FMT) to see if it can help prevent or reduce gastrointestinal symptoms like diarrhea, constipation, nausea, and vomiting in patients with extrapulmonary neuroendocrine neoplasms, which are a type of tumor that occurs outside the lungs. Researchers believe that FMT, which involves transferring healthy bacteria from a donor's stool into a patient's gut, may help restore balance to the gut microbiome and improve symptoms that often arise after cancer treatments like chemotherapy.

To join the study, participants must be at least 18 years old, have a confirmed diagnosis of extrapulmonary neuroendocrine neoplasms, and be experiencing gastrointestinal issues after starting standard treatment. They should also be able to swallow capsules and have a good overall health status as determined by medical tests. The trial is currently not recruiting participants, but once it begins, those who qualify can expect to receive the FMT treatment and will be monitored for any changes in their gastrointestinal symptoms and overall safety during the study.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years, regardless of gender;
• • 2. Anticipated survival period ≥3 months;
• • 3. Pathologically confirmed diagnosis of extrapulmonary neuroendocrine neoplasms;
• • 4. Development of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within three cycles of standard treatment;
• • 5. Patients are capable and willing to sign an informed consent form and complete follow-up;
• • 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
• • 7. No use of oral/intravenous broad-spectrum antibiotics within 3 days prior to enrollment;
• • 8. Ability to swallow capsules without chewing;
• • 9. Adequate organ function confirmed by screening laboratory tests.
• Exclusion Criteria:
• • 1. Patients with major organ dysfunction or failure, including but not limited to cardiac insufficiency/heart failure, renal insufficiency/failure, or hepatic insufficiency/failure;
• • 2. Uncontrolled or severe infection;
• • 3. Known history of psychotropic drug abuse, alcoholism, or substance abuse;
• • 4. Severe infection accompanied by sepsis or septicemia;
• • 5. History of severe allergic reactions or known allergy to components of the liquid live bacterial enteric-coated capsules;
• • 6. Female subjects with a positive pregnancy test, lactating women, or women of childbearing potential who refuse to use contraceptive measures during the observation period (15 weeks);
• • 7. Patients with gastrointestinal perforation and/or fistula;
• • 8. Other conditions deemed unsuitable for enrollment by the investigator.