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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Nanfang Hospital, Southern Medical University
WITHDRAWN
Guangzhou
Luohu District People's Hospital
NOT_YET_RECRUITING
Shenzhen
Shenzhen Hospital of Southern Medical University
RECRUITING
Shenzhen
Shenzhen University General Hospital
NOT_YET_RECRUITING
Shenzhen
Shunde Hospital of Southern Medical University
NOT_YET_RECRUITING
Shunde
Contact Information
Primary
Jun Huang
1473355495@qq.com
+8613189606428
Time Frame
Start Date: 2024-04-09
Estimated Completion Date: 2028-12
Participants
Target number of participants: 466
Treatments
Experimental: FMT group
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).
No_intervention: No treatment group
Participants are required to complete one colonoscopy and during the procedure, 150ml of saline is infused into the terminal ileum on day 0. Subsequently, participants don't need any treatment. The participants will receive their first colonoscopy follow-up 6 to 12 months after enrollment.
Related Therapeutic Areas
Sponsors
Leads: Shenzhen Hospital of Southern Medical University

This content was sourced from clinicaltrials.gov