Dynamic Changes of Gut Microbiota in UC After FMT
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2019
CompletedFirst Posted
Study publicly available on registry
May 14, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMay 14, 2019
May 1, 2019
3 months
May 12, 2019
May 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes of gut microbiota
gut microbiota will be collected through the colonic TET
7 days
Secondary Outcomes (1)
frequency of defecation
7 days
Study Arms (1)
colonic TET and FMT
EXPERIMENTALgut microbiota will be collected through the colonic TET after FMT
Interventions
Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- gut microbiota was not collected successfully
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Related Publications (2)
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.
PMID: 27556065BACKGROUNDWestwood 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.
PMID: 22228167BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
faming zhang, MD; PhD
The Second Hospital of Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2019
First Posted
May 14, 2019
Study Start
June 1, 2019
Primary Completion
September 1, 2019
Study Completion
December 1, 2019
Last Updated
May 14, 2019
Record last verified: 2019-05