Dynamic Changes of Gut Microbiota in UC After FMT
Primary Purpose
Ulcerative Colitis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
colonic transendoscopic enteral tubing
Sponsored by
About this trial
This is an interventional other trial for Ulcerative Colitis focused on measuring transendoscopic enteral tubing, gut microbiota, ulcerative colitis
Eligibility Criteria
Inclusion Criteria:
- Patients were diagnosed with mild or moderate ulcerative colitis.
- Patients need colonic TET and FMT
- Must be able to colonic TET and no contraindication by endoscopic examination, consent colon TET implantation and not associated with severe intestinal lesions such as fistula, stenosis, complex perianal lesions, severe ileocecal or ascending colon lesions resulting in no proper site for titanium clip fixation.
- Age > 7 years old and < 65 years old
Exclusion Criteria:
- gut microbiota was not collected successfully
Sites / Locations
- Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
colonic TET and FMT
Arm Description
gut microbiota will be collected through the colonic TET after FMT
Outcomes
Primary Outcome Measures
changes of gut microbiota
gut microbiota will be collected through the colonic TET
Secondary Outcome Measures
frequency of defecation
the frequency of defecation in UC patients will be recorded
Full Information
NCT ID
NCT03949257
First Posted
May 12, 2019
Last Updated
May 12, 2019
Sponsor
The Second Hospital of Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03949257
Brief Title
Dynamic Changes of Gut Microbiota in UC After FMT
Official Title
Dynamic Changes of Gut Microbiota in Patients With Ulcerative Colitis After Fecal Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A prospective study to investigate the dynamic changes of gut microbiota through colonic transendoscopic enteral tubing in patients with ulcerative colitis after fecal microbiota transplantation.
Detailed Description
Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment. This tube also can serve as a medium for collecting gut microbiota. Fecal Microbiota Transplantation (FMT) was identified to be promising for ulcerative colitis (UC). This study aims to investigate the dynamic changes of gut microbiota in patients with UC after FMT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
transendoscopic enteral tubing, gut microbiota, ulcerative colitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
colonic TET and FMT
Arm Type
Experimental
Arm Description
gut microbiota will be collected through the colonic TET after FMT
Intervention Type
Device
Intervention Name(s)
colonic transendoscopic enteral tubing
Other Intervention Name(s)
fecal microbiota transplantation
Intervention Description
Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment.
Primary Outcome Measure Information:
Title
changes of gut microbiota
Description
gut microbiota will be collected through the colonic TET
Time Frame
7 days
Secondary Outcome Measure Information:
Title
frequency of defecation
Description
the frequency of defecation in UC patients will be recorded
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients were diagnosed with mild or moderate ulcerative colitis.
Patients need colonic TET and FMT
Must be able to colonic TET and no contraindication by endoscopic examination, consent colon TET implantation and not associated with severe intestinal lesions such as fistula, stenosis, complex perianal lesions, severe ileocecal or ascending colon lesions resulting in no proper site for titanium clip fixation.
Age > 7 years old and < 65 years old
Exclusion Criteria:
gut microbiota was not collected successfully
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
faming zhang, MD; PhD
Phone
086-25-58509883
Email
fzhang@njmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
min dai, MD; PhD
Phone
086-25-58509884
Email
daimin@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
faming zhang, MD; PhD
Organizational Affiliation
The Second Hospital of Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27556065
Citation
Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.
Results Reference
background
PubMed Identifier
22228167
Citation
Westwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: a systematic review and meta-analysis. Dis Colon Rectum. 2012 Feb;55(2):218-25. doi: 10.1097/DCR.0b013e31823461ef.
Results Reference
background
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Dynamic Changes of Gut Microbiota in UC After FMT
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