Clinical Response and Safety Following FMT for UC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflammatory Bowel Diseases Fecal Microbiota Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FMT through a naso-jejunal tube

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

Group Type EXPERIMENTAL

FMT through a naso-jejunal tube

Intervention Type OTHER

Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a naso-jejunal tube.

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.

Group Type ACTIVE_COMPARATOR

FMT through TET

Intervention Type OTHER

Prepared feces by automatic methods, then 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.

Interventions

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FMT through a naso-jejunal tube

Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a naso-jejunal tube.

Intervention Type OTHER

FMT through TET

Prepared feces by automatic methods, then 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No