Fecal Microbiota Transplantation for Ulcerative Colitis

Phase 2

Recruiting

• Conditions: Fecal Microbiota Transplantation; Ulcerative Colitis
• Interventions: Procedure: Fecal microbiota transplantation; Procedure: Infusion of Saline; Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone

• Registration Number: NCT03804931
• Lead Sponsor: Guangzhou First People's Hospital

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.

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2019-01-06
• Study First Submitted QC: 2019-01-12
• Last Update Submitted: 2019-01-12
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15
• Study Start: 2019-01-20
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal microbiota transplantation	5-Aminosalicylic acid(5-ASA) and/or Prednisone	Fecal microbiota transplantation
Fecal microbiota transplantation	Fecal microbiota transplantation	Fecal microbiota transplantation
placebo fecal microbiota transplantation	Infusion of Saline	Infusion of Saline
placebo fecal microbiota transplantation	5-Aminosalicylic acid(5-ASA) and/or Prednisone	Infusion of Saline
Traditional treatments	5-Aminosalicylic acid(5-ASA) and/or Prednisone	Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone

Primary Outcome Measures

Name	Time	Method
Clinical remission in patient as assessed using Mayo score	12 weeks	Total Mayo score less than 2 and no signal item more than 1
Clinical improvement in patient as assessed using Mayo score	12 weeks	Total Mayo score decreased more than 3

Secondary Outcome Measures

Name	Time	Method
Intestinal microbiota changing	12 weeks	The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota

Trial Locations

Locations (1)

Guangzhou First People's Hospital; 🇨🇳 Guangzhou, Guangdong, China