Trial Title:
Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)
NCT ID:
NCT06205862
Condition:
Fecal Microbiota Transplantation
Colorectal Adenoma
Gastrointestinal Microbiome
Conditions: Official terms:
Adenoma
Recurrence
Conditions: Keywords:
Fecal Microbiota Transplantation
Colorectal Adenomas
Gastrointestinal Microbiome
Recurrence rate after endoscopic resection
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
fecal microbiota transplantation
Description:
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).
Arm group label:
FMT group
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).
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 significant rate of recurrence following this procedure,
which poses a challenge for long-term management and prevention of colorectal cancer.
Recent research has suggested a potential role for the gut microbiota in the development
and recurrence of colorectal adenomas. Fecal microbiota transplantation (FMT) has been
proposed as a novel strategy to manipulate the microbiota to reduce the recurrence of
these lesions. This clinical trial aims to investigate both the efficacy and safety of
FMT in reducing the recurrence of colorectal adenomas post endoscopic resection, and to
elucidate the changes in intestinal and mucosal microbiota associated with the treatment.
The clinical trial is designed as a randomized controlled study where participants who
have undergone endoscopic resection for colorectal adenomas are enrolled to receive FMT.
The primary objective is to assess the efficacy of FMT in reducing the recurrence rate of
colorectal adenomas. The secondary objective is to evaluate the safety of FMT in this
patient population and to examine the changes in intestinal and mucosal microbiota before
and after endoscopic treatment and FMT.
Participants are required to undergo a baseline colonoscopy to ensure the absence of
residual adenomas post endoscopic resection. Following this, on day 0, participants will
receive their first FMT via infusion of 150ml of fecal suspension into the terminal ileum
under endoscopic guidance. This procedure aims to directly alter the gut microbiota by
introducing a healthy donor's fecal material.
The FMT treatment is continued orally in the form of capsules for the next two days.
Participants are instructed to ingest a considerable number of FMT capsules (40 capsules
per day, 20 capsules twice daily) to maintain the introduced microbiota's presence and
potential therapeutic effect.
After the initial intensive treatment phase, participants enter a maintenance phase where
they receive oral FMT capsules at 3, 6, and 9 months (approximately every 75 to 90 days).
This phase is designed to establish a newly balanced and potentially disease-modifying
gut microbiome, allowing for a longitudinal assessment of the FMT's efficacy in reducing
adenoma recurrence.
Safety assessments are performed throughout the trial, including monitoring for adverse
events related to the FMT procedure and the overall health status of participants. Stool
samples are collected at various time points to analyze changes in the gut microbiota
composition using molecular techniques.
This clinical trial represents a critical step in understanding the potential role of FMT
in preventing the recurrence of colorectal adenomas following endoscopic resection. By
investigating both the efficacy and safety of FMT, as well as the associated changes in
the gut microbiota, this study could significantly contribute to the development of novel
therapeutic strategies for colorectal cancer prevention. If successful, this approach
could provide a non-invasive and potentially effective treatment modality for patients at
risk of recurrent colorectal adenomas, ultimately improving patient outcomes and reducing
the burden of colorectal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75, gender not specified.
2. 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.
3. Individuals who are able to swallow pills/capsules.
4. 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:
1. Individuals in whom the adenoma was not completely removed in a previous
colonoscopy;
2. Individuals who experienced serious complications during or after adenoma resection,
including perforation, uncontrollable bleeding, or severe infection;
3. Individuals with a history of familial adenomatous polyposis (FAP) or hereditary
nonpolyposis colorectal cancer (HNPCC/Lynch syndrome);
4. Individuals regularly taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs),
cyclooxygenase 2 (COX2) inhibitors, calcium, or vitamin D;
5. Individuals with a history of subtotal or total gastrectomy or partial bowel
resection;
6. People who cannot tolerate colonoscopy;
7. Individuals with allergic diathesis, known allergies to fecal microbiota
transplantation, drug allergies, or intolerance;
8. Individuals with serious heart, liver, or kidney diseases, or any history of cancer;
9. People suffering from severe constipation;
10. Pregnant women, breastfeeding mothers, or women planning to become pregnant;
11. Patients with mental illness who are unable to cooperate;
12. Individuals involved in the design, planning, or execution of this trial;
13. Any other individuals who, in the investigator's opinion, are unsuitable for
inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanfang Hospital, Southern Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Withdrawn
Facility:
Name:
Shenzhen Hospital of Southern Medical University
Address:
City:
Shenzhen
Zip:
518000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Huang
Phone:
+8613189606428
Email:
1473355495@qq.com
Contact backup:
Last name:
Ye Chen, MD
Email:
chenye_2013@163.com
Facility:
Name:
Luohu District People's Hospital
Address:
City:
Shenzhen
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jun huang
Facility:
Name:
Shenzhen University General Hospital
Address:
City:
Shenzhen
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jun Huang
Facility:
Name:
Shunde Hospital of Southern Medical University
Address:
City:
Shunde
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jun Huang
Start date:
April 9, 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Shenzhen Hospital of Southern Medical University
Agency class:
Other
Source:
Shenzhen Hospital of Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06205862
