Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

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There are many limitations in the current treatments of Inflammatory bowel disease (IBD). Now the investigators realized that the intestinal microecological is closely associated with the development of IBD. So the standardized fecal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators will recruit 40 patients with IBD (20 cases of Ulcerative Colitis and 20 cases of Crohn's disease) in China. The patients will be randomly divided into 2 groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with mesalazine, followed up for at least 1 year. The investigators propose to determine the efficiency, durability and safety of Standardized Fecal Microbiota Transplantation for IBD treatment.

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Detailed Description

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In this projects the investigators aim to re-establish a gut balance of intestinal microecological through Standardized Fecal Microbiota Transplantation for IBD (UC and CD). We will establish a standardized isolation, store, and transportion steps of fecal bacteria from donated fresh stool in the laboratory. Then the bacteria will be transplanted to mid-gut by nose-jejunum nutrition tube. Patients in this study will be assigned to receive standardized FMT only once or traditional medicine of mesalazine and would be followed up for at least 1 year. The clinical symptoms, sign, blood tests, abdominal CT, endoscopy and questionnaire will be used to assess the efficiency, durability and safety of Standardized FMT at the start and end of the projects.

Conditions

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Inflammatory Bowel Disease Ulcerative Colitis Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standardized FMT

The group include 20 patients. They will receive standardized FMT. The FMT was given to mid-gut by nose-jejunum nutrition tube. It was given only once.

Group Type EXPERIMENTAL

FMT

Intervention Type PROCEDURE

Standardized FMT once

Mesalazine

This group include 20 patients . The patients will receive traditional medicine of mesalazine treatment.

Group Type ACTIVE_COMPARATOR

Mesalazine

Intervention Type DRUG

2g Po perday

Interventions

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FMT

Standardized FMT once

Intervention Type PROCEDURE

Mesalazine

2g Po perday

Intervention Type DRUG

Other Intervention Names

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Mesalamine

Eligibility Criteria

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Inclusion Criteria

* Severe IBD define as HBI score ≥ 9.
* Moderate IBD define as 7\<HBI \<9
* Montreal classification: Age \> 14 years old, Location L1-3, Behavior B1-3.

Exclusion Criteria

* Diarrhea activity scores \< 3
* Severely active disease with perianal diseases
* Severely active disease with indication of surgery.
* Diagnosis as IBD first time or first year.
* No history of using 5-ASA, biological (antibody), immunomodulatory therapy, corticosteroid therapy

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No