Using fecal microbiota transplantation to reduce colorectal adenoma recurrence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of fecal microbiota transplantation (FMT) in patients who have undergone endoscopic resection for colorectal adenomas. Participants will receive an initial FMT via colonoscopy, followed by oral capsules for two days. The study aims to assess the recurrence rate of colorectal adenomas and analyze changes in the intestinal and mucosal microbiota before and after treatment. It is designed as a randomized controlled trial to provide robust data on the potential benefits of FMT in this context.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shenzhen Hospital of Southern Medical University
  Shenzhen, Guangdong, China Recruiting
• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Withdrawn
• Luohu District People's Hospital
  Shenzhen, Guangdong, China Not yet recruiting
• Shenzhen University General Hospital
  Shenzhen, Guangdong, China Not yet recruiting
• Shunde Hospital of Southern Medical University
  Shunde, Guangdong, China Not yet recruiting

Study contacts

• Principal investigator: Ye Chen, MD — Shenzhen Hospital of Southern Medical University
• Study coordinator: Jun Huang
• Email: 1473355495@qq.com
• Phone: +8613189606428

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.