Dynamic Changes of Gut Microbiota in UC After FMT

Nanjing Medical University

Status: Unknown

Conditions: Ulcerative Colitis

Treatments: Device: colonic transendoscopic enteral tubing

Study type: Interventional

Funder types: Other

Identifiers

NCT03949257

FMT-TET-190507

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 7 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

colonic TET and FMT

Experimental group

Description:

gut microbiota will be collected through the colonic TET after FMT

Treatment:

Device: colonic transendoscopic enteral tubing