Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)

NCT06205862 | Recruiting Phase 2

• 1 other identifier: 20231219v2.6
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 5

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 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

Fecal Microbiota Transplantation; Colorectal Adenoma; Gastrointestinal Microbiome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• CRA recurrence rate

  Percentage of patients who has recurrence of CRA(colorectal adenoma) during or after FMT.

  6~12 months

Secondary Outcomes (5)

• Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0

  1~12 months

• Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)

  1~12 months

• All polypoid lesions incidence rate

  6~12 months

• CRC incidence rate

  6~12 months

• Changes in intestinal mucosal microbiota Pre- and Post-FMT

  1~12 months

Study Arms (2)

FMT group

EXPERIMENTAL

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).

Procedure: fecal microbiota transplantation

No treatment group

NO INTERVENTION

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.

Interventions

fecal microbiota transplantation PROCEDURE

We will use fecal suspensions and capsules prepared from the feces of healthy donors for 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).

FMT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shenzhen Hospital of Southern Medical University: lead

Study Sites (5)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

WITHDRAWN

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 518000, 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

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Ye Chen, MD

  Shenzhen Hospital of Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Huang

CONTACT

+8613189606428; 1473355495@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 16, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)