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

NCT06924645 | Not Yet Recruiting

• 1 other identifier: 2025-0198
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Treatment-related Gastrointestinal Toxicity (Including Diarrhea, Constipation, Nausea, and Vomiting); Extrapulmonary Neuroendocrine Neoplasms

Outcome Measures

Primary Outcomes (1)

• Improvement in treatment-related gastrointestinal symptoms

  Hart Diarrhea Score

  Assessed every two cycles (6 weeks)

Secondary Outcomes (3)

• Chemotherapy cycle delay rate

  Assessed every two cycles (6 weeks)

• Quality of Life (QoL) assessment

  Assessed every two cycles (6 weeks)

• Gut microbiota colonization

  Assessed every two cycles (6 weeks)

Study Arms (2)

Fecal microbiota transplantation

EXPERIMENTAL

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

Procedure: Fecal Microbiota Transplant (FMT)

Control

ACTIVE COMPARATOR

Standard Therapy Alone

Other: Standard Therapy

Interventions

Fecal Microbiota Transplant (FMT) PROCEDURE

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

Fecal microbiota transplantation

Standard Therapy OTHER

Standard Therapy Alone

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Constipation; Nausea; Vomiting

Interventions

Fecal Microbiota Transplantation; Standard of Care

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 11, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 11, 2025

Record last verified: 2025-02

Locations

CN (1)