Fecal Microbiota Transplantation for Ulcerative Colitis

Guangzhou First People's Hospital

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Ulcerative Colitis; Fecal Microbiota Transplantation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03804931

K-2017-103-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Fecal microbiota transplantation

Experimental group

Description:

Fecal microbiota transplantation

Treatment:

Procedure: Fecal microbiota transplantation

Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone

placebo fecal microbiota transplantation

Sham Comparator group

Description:

Infusion of Saline

Treatment:

Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone

Procedure: Infusion of Saline

Traditional treatments

Other group

Description:

Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone

Treatment:

Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone