Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorecta… (NCT06205862) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)
China466 participantsStarted 2024-04-09
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. Individuals in whom the adenoma was not completely removed in a previous colonoscopy;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CRA recurrence rate
Timeframe: 6~12 months
Trial details
NCT IDNCT06205862
SponsorShenzhen Hospital of Southern Medical University
. 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);