Using fecal microbiota transplantation to reduce colorectal adenoma recurrence

Efficacy and Safety of Fecal Microbiota Transplantation in Reducing Recurrence of Colorectal Adenomas After Endoscopic Resection: a Multicenter, Open-label, Randomized Controlled Study

This study tests if a treatment using healthy gut bacteria can help prevent the return of colorectal adenomas in patients who have had them removed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 466 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shenzhen Hospital of Southern Medical University (Academic / other)
• Locations: 5 sites (Guangzhou, Guangdong and 4 other locations)
• Trial ID: NCT06205862 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who have been diagnosed with colorectal adenomas and treated with endoscopic resection within the past six months.

Not a fit: Patients who have not had their adenomas completely removed or those with serious complications from previous procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the recurrence of colorectal adenomas, potentially lowering the risk of colorectal cancer.

How similar studies have performed: While the use of fecal microbiota transplantation is a novel approach in this specific context, preliminary research suggests potential benefits, although this specific application is less commonly tested.

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.

Where this trial is running

Guangzhou, Guangdong and 4 other locations

• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Withdrawn)
• Shenzhen Hospital of Southern Medical University — Shenzhen, Guangdong, China (Recruiting)
• 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

Conditions Fecal Microbiota Transplantation; Colorectal Adenoma; Gastrointestinal Microbiome; Colorectal Adenomas; Recurrence rate after endoscopic resection