Fecal Microbiota Transplantation for Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03804931
• Other study ID #: K-2017-103-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 20, 2019
• Est. completion date: December 31, 2030

Study information

• Verified date: November 2018
• Source: Guangzhou First People's Hospital
• Contact: Hongli Huang, MM
• Phone: 86-13631316718
• Email: honglisums[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Fecal Microbiota Transplantation
• Ulcer
• Ulcerative Colitis

Intervention

Procedure:
• Fecal microbiota transplantation
200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine
• Infusion of Saline
Infusion of Saline

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

Locations

Country	Name	City	State
China	Guangzhou First People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission in patient as assessed using Mayo score	Total Mayo score less than 2 and no signal item more than 1	12 weeks
Primary	Clinical improvement in patient as assessed using Mayo score	Total Mayo score decreased more than 3	12 weeks
Secondary	Intestinal microbiota changing	The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota	12 weeks