Fecal Microbiota Transplantation for Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).

Detailed Description
-----------------
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.

Official Title
-----------------
Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis, Fecal Microbiota Transplantation

Intervention / Treatment
-----------------
* Procedure: Fecal microbiota transplantation
* Procedure: Infusion of Saline
* Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active, moderate to severe severity (Mayo score more than 6) Safety using history of 5-ASA Able to undergo endoscopy examination Exclusion Criteria: Antibiotic using in 7 days High risk of toxic megacolon Colon cancer or neoplasia in pathophysiology Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal microbiota transplantation<br>Fecal microbiota transplantation | Procedure: Fecal microbiota transplantation<br>* 200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine<br>Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone<br>* Mesalazine and/or Prednisone<br>* Other names: Prednisone;|
| Sham Comparator: placebo fecal microbiota transplantation<br>Infusion of Saline | Procedure: Infusion of Saline<br>* Infusion of Saline<br>Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone<br>* Mesalazine and/or Prednisone<br>* Other names: Prednisone;|
| Other: Traditional treatments<br>Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone | Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone<br>* Mesalazine and/or Prednisone<br>* Other names: Prednisone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission in patient as assessed using Mayo score | Total Mayo score less than 2 and no signal item more than 1 | 12 weeks | 
| Clinical improvement in patient as assessed using Mayo score | Total Mayo score decreased more than 3 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal microbiota changing | The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota | 12 weeks |