Clinical Response and Safety Following FMT for UC

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases; Fecal Microbiota Transplantation
• Interventions: Other: FMT through a naso-jejunal tube; Other: FMT through TET

• Registration Number: NCT04294615
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2018-03-16
• Study Completion: 2018-03-31
• Status Verified: 2020-03
• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-02
• Last Update Submitted: 2020-03-02
• Study First Posted: 2020-03-04
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 ≥2. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT through a naso-jejunal tube	FMT through a naso-jejunal tube	The purified fecal microbiota was delivered into the intestine through a naso-jejunal tube.
FMT through TET	FMT through TET	The purified fecal microbiota was delivered into the intestine through a transendoscopic enteral tubing (TET) which is fixed to the cecum with clips under endoscopic guidance.

Primary Outcome Measures

Name	Time	Method
clinical response	2 weeks after FMT	reduction in the Mayo score of ≥3 points and ≥30% from baseline, with a decrease in the rectal bleeding subscore of ≥1 point or a subscore of ≤1

Secondary Outcome Measures

Name	Time	Method
clinical remission, safety and progression of disease	2 weeks after FMT	clinical remission: Mayo score ≤ 2, with no subscore \> 1; progression of disease: measured by initiation of anti-TNFα or colectomy. Adverse event severity and relatedness was graded using NIH criteria.