Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)

Launched by SHENZHEN HOSPITAL OF SOUTHERN MEDICAL UNIVERSITY · Jan 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called fecal microbiota transplantation (FMT) to see if it can help prevent the return of colorectal adenomas, which are growths in the colon that can potentially lead to cancer. The trial is particularly focusing on patients who have had these growths removed through a procedure called endoscopic resection. Researchers want to find out if FMT can effectively reduce the chances of these adenomas coming back and how it affects the gut bacteria in patients before and after treatment.

To participate in this study, individuals should be between the ages of 18 and 75 and have recently had colorectal adenomas removed. Participants will undergo a colonoscopy and receive FMT through a procedure and then take capsules containing the treatment for several months. They will have follow-up colonoscopies to monitor their progress. However, certain individuals, such as those with specific health conditions or complications from previous treatments, will not be eligible. This trial is currently recruiting participants and aims to provide valuable insights into a new approach for managing colorectal health.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-75, gender not specified.
• • 2. Colorectal adenoma patients diagnosed by colonoscopy and treated with endoscopic resection (such as EMR, ESD, APC treatment, etc.)，or patients who have undergone endoscopic resection within the past 6 months and have pathologically confirmed colorectal adenoma.
• • 3. Individuals who are able to swallow pills/capsules.
• • 4. Individuals who voluntarily sign an informed consent form after fully understanding the purpose and procedures of this study, the characteristics of the disease, the therapeutic efficacy of the drugs, the related examination methods, and the potential risks/benefits of the study.
• Exclusion Criteria:
• • 1. Individuals in whom the adenoma was not completely removed in a previous colonoscopy;
• • 2. Individuals who experienced serious complications during or after adenoma resection, including perforation, uncontrollable bleeding, or severe infection;
• • 3. Individuals with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC/Lynch syndrome);
• • 4. Individuals regularly taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase 2 (COX2) inhibitors, calcium, or vitamin D;
• • 5. Individuals with a history of subtotal or total gastrectomy or partial bowel resection;
• • 6. People who cannot tolerate colonoscopy;
• • 7. Individuals with allergic diathesis, known allergies to fecal microbiota transplantation, drug allergies, or intolerance;
• • 8. Individuals with serious heart, liver, or kidney diseases, or any history of cancer;
• • 9. People suffering from severe constipation;
• • 10. Pregnant women, breastfeeding mothers, or women planning to become pregnant;
• • 11. Patients with mental illness who are unable to cooperate;
• • 12. Individuals involved in the design, planning, or execution of this trial;
• • 13. Any other individuals who, in the investigator's opinion, are unsuitable for inclusion.