Dynamic Changes of Gut Microbiota in UC After FMT

Not Applicable

• Conditions: Ulcerative Colitis
• Interventions: Device: colonic transendoscopic enteral tubing

• Registration Number: NCT03949257
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-12
• Study First Submitted QC: 2019-05-12
• Last Update Submitted: 2019-05-12
• Study First Posted: 2019-05-14
• Last Update Posted: 2019-05-14
• Study Start: 2019-06-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
colonic TET and FMT	colonic transendoscopic enteral tubing	gut microbiota will be collected through the colonic TET after FMT

Primary Outcome Measures

Name	Time	Method
changes of gut microbiota	7 days	gut microbiota will be collected through the colonic TET

Secondary Outcome Measures

Name	Time	Method
frequency of defecation	7 days	the frequency of defecation in UC patients will be recorded

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China