NCT06205862 Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)
| NCT ID | NCT06205862 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shenzhen Hospital of Southern Medical University |
| Condition | Fecal Microbiota Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 466 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 466 participants in total. It began in 2024-04-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Ye Chen, MD
PRINCIPAL INVESTIGATOR
Shenzhen Hospital of Southern Medical University
Frequently Asked Questions
Who can join the NCT06205862 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Fecal Microbiota Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06205862 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06205862 currently recruiting?
Yes, NCT06205862 is actively recruiting participants. Contact the research team at 1473355495@qq.com for enrollment information.
Where is the NCT06205862 trial being conducted?
This trial is being conducted at Guangzhou, China, Shenzhen, China, Shenzhen, China, Shenzhen, China and 1 additional location.
Who is sponsoring the NCT06205862 clinical trial?
NCT06205862 is sponsored by Shenzhen Hospital of Southern Medical University. The principal investigator is Ye Chen, MD at Shenzhen Hospital of Southern Medical University. The trial plans to enroll 466 participants.