Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)
Efficacy and Safety of Fecal Microbiota Transplantation in Reducing Recurrence of Colorectal Adenomas After Endoscopic Resection: a Multicenter, Open-label, Randomized Controlled Study
Shenzhen Hospital of Southern Medical University
466 participants
Apr 9, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn about the efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection. The main questions it aims to answer are: * the efficacy and safety of fecal microbiota transplantation in reducing the recurrence rate of colorectal adenomas after endoscopic resection. * changes in the intestinal and mucosal microbiota of patients before and after endoscopic treatment. * changes in the intestinal and mucosal microbiota of patients before and after fecal microbiota transplantation. Participants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months).
Eligibility
Inclusion Criteria4
- Age 18-75, gender not specified.
- 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.
- Individuals who are able to swallow pills/capsules.
- 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 Criteria13
- Individuals in whom the adenoma was not completely removed in a previous colonoscopy;
- Individuals who experienced serious complications during or after adenoma resection, including perforation, uncontrollable bleeding, or severe infection;
- Individuals with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC/Lynch syndrome);
- Individuals regularly taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase 2 (COX2) inhibitors, calcium, or vitamin D;
- Individuals with a history of subtotal or total gastrectomy or partial bowel resection;
- People who cannot tolerate colonoscopy;
- Individuals with allergic diathesis, known allergies to fecal microbiota transplantation, drug allergies, or intolerance;
- Individuals with serious heart, liver, or kidney diseases, or any history of cancer;
- People suffering from severe constipation;
- Pregnant women, breastfeeding mothers, or women planning to become pregnant;
- Patients with mental illness who are unable to cooperate;
- Individuals involved in the design, planning, or execution of this trial;
- Any other individuals who, in the investigator's opinion, are unsuitable for inclusion.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
We will use fecal suspensions and capsules prepared from the feces of healthy donors for fecal microbiota transplantation. Participants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months).
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06205862