Clinical Response and Safety Following FMT for UC

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Inflammatory Bowel Diseases; Fecal Microbiota Transplantation

Treatments: Other: FMT through a naso-jejunal tube; Other: FMT through TET

Study type: Interventional

Funder types: Other

Identifiers

NCT04294615

LL-KY-20150305

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

FMT through a naso-jejunal tube

Experimental group

Description:

The purified fecal microbiota was delivered into the intestine through a naso-jejunal tube.

Treatment:

Other: FMT through a naso-jejunal tube

FMT through TET

Active Comparator group

Description:

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.

Treatment:

Other: FMT through TET