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Clinical Response and Safety Following FMT for UC

Primary Purpose

Inflammatory Bowel Diseases, Fecal Microbiota Transplantation

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

FMT through a naso-jejunal tube

FMT through TET

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FMT through a naso-jejunal tube

FMT through TET

Arm Description

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

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.

Outcomes

Primary Outcome Measures

clinical response

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

clinical remission, safety and progression of disease

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.

Full Information

NCT ID

NCT04294615

First Posted

March 2, 2020

Last Updated

March 2, 2020

Sponsor

Air Force Military Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT04294615

Brief Title

Clinical Response and Safety Following FMT for UC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

April 1, 2016 (Actual)

Primary Completion Date

March 16, 2018 (Actual)

Study Completion Date

March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Diseases, Fecal Microbiota Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FMT through a naso-jejunal tube

Arm Type

Experimental

Arm Description

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

Arm Title

FMT through TET

Arm Type

Active Comparator

Arm 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.

Intervention Type

Other

Intervention Name(s)

FMT through a naso-jejunal tube

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

FMT through TET

Intervention Description

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.

Primary Outcome Measure Information:

Title

clinical response

Description

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

Time Frame

2 weeks after FMT

Secondary Outcome Measure Information:

Title

clinical remission, safety and progression of disease

Description

Time Frame

2 weeks after FMT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 ≥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.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Response and Safety Following FMT for UC

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