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

China40 participantsStarted 2025-05-01

Plain-language 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, Bacteroides, Bifidobacterium, and Enterococcus genera in their feces following chemotherapy. Research reports indicate a significant decline in bacterial diversity in rectal cancer patients post-chemotherapy, particularly showing reduced abundances of Porphyromonas, Peptostreptococcus, and Veillonella. Motoori et al. found that esophageal cancer patients undergoing combined chemotherapy with 5-FU, cisplatin, and docetaxel experienced significant reductions in intestinal Lactobacillus, alongside notable increases in Clostridium difficile and Enterococcus. Iida et al. confirmed that gut microbiota enhances the therapeutic efficacy of platinum-based agents and CpG oligonucleotides in cancer treatment. Concurrent studies suggest that probiotic supplementation during chemotherapy alleviates chemotherapy-related gastrointestinal reactions. Fecal microbiota transplantation (FMT), which involves transferring functional microbiota from healthy donors to patients' gastrointestinal tracts to reconstruct gut microbiota and improve microbial homeostasis, has emerged as a key clinical approach for regulating gut dysbiosis. It is currently recognized as the most effective established therapy for recurrent Clostridioides difficile infection (CDI). Previous studies have indicated FMT as a relatively safe, effective, and recommended treatment modality, while providing theoretical and experimental foundations for elucidating its efficacy and safety in preventing/reducing gastrointestinal symptoms associated with digestive tract cancer therapies. This study aims to evaluate the improvement of treatment-related gastrointestinal symptoms and safety profile of FMT in extrapulmonary neuroendocrine tumor patients.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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;

Exclusion criteria

✕. Patients with major organ dysfunction or failure, including but not limited to cardiac insufficiency/heart failure, renal insufficiency/failure, or hepatic insufficiency/failure;

What they're measuring

Improvement in treatment-related gastrointestinal symptoms

Timeframe: Assessed every two cycles (6 weeks)

Trial details

NCT IDNCT06924645

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

View on ClinicalTrials.gov More Treatment-related Gastrointestinal Toxicity (Including Diarrhea, Constipation, Nausea, and Vomiting) trials