Clinical Response and Safety Following Fecal Microbiota Transplantation by Automatic Methods in Patients With Moderate-Severe Active Ulcerative Colitis

Air Force Military Medical University, China0 sites9 target enrollmentApril 1, 2016

ConditionsInflammatory Bowel Diseases Fecal Microbiota Transplantation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inflammatory Bowel Diseases
Sponsor: Air Force Military Medical University, China
Enrollment: 9
Primary Endpoint: clinical response
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The study aims to evaluate the clinical efficacy and safety of fecal microbiota transplantation by automatic methods in the treatment of moderate to severe active ulcerative colitis. There are two groups according to FMT pathway ( through a naso-jejunal tube or transendoscopic enteral tubing). Patients were followed up until 2 weeks after the final FMT in hospital.

Registry

clinicaltrials.gov

Start Date

April 1, 2016

End Date

March 31, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Air Force Military Medical University, China

Responsible Party

Principal Investigator

Yujie Zhang

Xijing Hospital of Digestive Diseases

Air Force Military Medical University, China

Eligibility Criteria

Inclusion Criteria

•Eligible patients required a diagnosis of ulcerative colitis made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies and gastrointestinal histology. All patients were age ≥ 18 year old at the time of enrollment. They had moderate to severe symptoms with a mayo score between 6\~12 and an endoscopic subscore ≥
•Patient medication for UC could not have changed for at least one month prior to FMT.

Exclusion Criteria

•Active or history of intraabdominal abscess, acute abdomen or other clinical emergencies requiring emergent management, pregnancy, prior history of FMT, prior history of TNF inhibitors use, or other serious systemic disease.