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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06924645
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Treatment-related Gastrointestinal Toxicity (Including Diarrhea, Constipation, Nausea, and Vomiting), Extrapulmonary Neuroendocrine Neoplasms

Arms & Interventions

Arms

Experimental: Fecal microbiota transplantation

Fecal Microbiota Transplantation (FMT) is delivered as a single dose of oral microbiota capsules within 72 hours before starting standard therapy.

Active Comparator: Control

Standard Therapy Alone

Interventions

Procedure: - Fecal Microbiota Transplant (FMT)

Fecal Microbiota Transplantation (FMT) is delivered as a single dose of oral microbiota capsules within 72 hours before starting standard therapy.

Other: - Standard Therapy

Standard Therapy Alone

Contact a Trial Team

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International Sites

Hangzhou, Zhejiang, China

Status

Address

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang,

Site Contact

Wen Cai

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