Status:
NOT_YET_RECRUITING
Fecal Microbiota Transplantation for Preventing Gastrointestinal Symptoms in Extrapulmonary Neuroendocrine Neoplasms: A Real-World Study
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Treatment-related Gastrointestinal Toxicity (Including Diarrhea, Constipation, Nausea, and Vomiting)
Extrapulmonary Neuroendocrine Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Existing studies have demonstrated that patients with different types of tumors exhibit significant increases in Enterobacter and Staphylococcus genera, along with marked decreases in Lactobacillus, B...
Eligibility Criteria
Inclusion
- Age ≥18 years, regardless of gender;
- Anticipated survival period ≥3 months;
- Pathologically confirmed diagnosis of extrapulmonary neuroendocrine neoplasms;
- Development of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within three cycles of standard treatment;
- Patients are capable and willing to sign an informed consent form and complete follow-up;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
- No use of oral/intravenous broad-spectrum antibiotics within 3 days prior to enrollment;
- Ability to swallow capsules without chewing;
- Adequate organ function confirmed by screening laboratory tests.
Exclusion
- Patients with major organ dysfunction or failure, including but not limited to cardiac insufficiency/heart failure, renal insufficiency/failure, or hepatic insufficiency/failure;
- Uncontrolled or severe infection;
- Known history of psychotropic drug abuse, alcoholism, or substance abuse;
- Severe infection accompanied by sepsis or septicemia;
- History of severe allergic reactions or known allergy to components of the liquid live bacterial enteric-coated capsules;
- 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);
- Patients with gastrointestinal perforation and/or fistula;
- Other conditions deemed unsuitable for enrollment by the investigator.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06924645
Start Date
May 1 2025
End Date
December 31 2028
Last Update
April 11 2025
Active Locations (1)
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1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China