Actively Recruiting
Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)
Led by Shenzhen Hospital of Southern Medical University · Updated on 2024-07-15
466
Participants Needed
5
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with colorectal adenomas by colonoscopy and treated with endoscopic resection, or had endoscopic resection within the past 6 months with pathologically confirmed colorectal adenoma
- Able to swallow pills or capsules
- Voluntarily signed informed consent after understanding the study purpose, procedures, possible risks, and benefits
You will not qualify if you...
- Adenoma not completely removed in previous colonoscopy
- Experienced serious complications such as perforation, uncontrollable bleeding, or severe infection after adenoma resection
- History of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC/Lynch syndrome)
- Regularly taking aspirin, NSAIDs, COX2 inhibitors, calcium, or vitamin D
- History of subtotal or total gastrectomy or partial bowel resection
- Unable to tolerate colonoscopy
- Allergic to fecal microbiota transplantation, drugs, or intolerant
- Serious heart, liver, or kidney diseases or any cancer history
- Severe constipation
- Pregnant, breastfeeding, or planning pregnancy
- Mental illness preventing cooperation
- Involved in the design, planning, or execution of this trial
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Withdrawn
2
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China, 518000
Actively Recruiting
3
Luohu District People's Hospital
Shenzhen, Guangdong, China
Not Yet Recruiting
4
Shenzhen University General Hospital
Shenzhen, Guangdong, China
Not Yet Recruiting
5
Shunde Hospital of Southern Medical University
Shunde, Guangdong, China
Not Yet Recruiting
Research Team
J
Jun Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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