Status:
RECRUITING
Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)
Lead Sponsor:
Shenzhen Hospital of Southern Medical University
Conditions:
Fecal Microbiota Transplantation
Colorectal Adenoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 questi...
Detailed Description
Colorectal adenomas are precancerous lesions that can lead to colorectal cancer if not effectively managed. The standard treatment for colorectal adenomas is endoscopic resection. However, there is a ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT06205862
Start Date
April 9 2024
End Date
December 1 2028
Last Update
July 15 2024
Active Locations (5)
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1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
2
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China, 518000
3
Luohu District People's Hospital
Shenzhen, Guangdong, China
4
Shenzhen University General Hospital
Shenzhen, Guangdong, China