NCT03804931

Fecal Microbiota Transplantation for Ulcerative Colitis

Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Guangzhou First People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis
• Fecal Microbiota Transplantation

Interventions

Type	Name	Description
PROCEDURE	Fecal microbiota transplantation	200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine
PROCEDURE	Infusion of Saline	Infusion of Saline
DRUG	5-Aminosalicylic acid(5-ASA) and/or Prednisone	Mesalazine and/or Prednisone

Timeline

• Start date: 2019-01-20
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2019-01-15
• Last updated: 2019-01-15

Locations

1 site across 1 country: China