Clinical Response and Safety Following FMT for UC

Inflammatory Bowel Diseases Clinical Trial

Official title:

Clinical Response and Safety Following Fecal Microbiota Transplantation by Automatic Methods in Patients With Moderate-Severe Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294615
• Other study ID #: LL-KY-20150305
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: March 31, 2018

Study information

• Verified date: March 2020
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate the clinical efficacy and safety of fecal microbiota transplantation by automatic methods in the treatment of moderate to severe active ulcerative colitis. There are two groups according to FMT pathway ( through a naso-jejunal tube or transendoscopic enteral tubing). Patients were followed up until 2 weeks after the final FMT in hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 31, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Eligible patients required a diagnosis of ulcerative colitis made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies and gastrointestinal histology. All patients were age = 18 year old at the time of enrollment. They had moderate to severe symptoms with a mayo score between 6~12 and an endoscopic subscore =2. Patient medication for UC could not have changed for at least one month prior to FMT.

Exclusion Criteria:

• Active or history of intraabdominal abscess, acute abdomen or other clinical emergencies requiring emergent management, pregnancy, prior history of FMT, prior history of TNF inhibitors use, or other serious systemic disease.

Related Conditions & MeSH terms

• Fecal Microbiota Transplantation
• Inflammatory Bowel Diseases

Intervention

Other:
• FMT through a naso-jejunal tube
Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a naso-jejunal tube.
• FMT through TET
Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a transendoscopic enteral tubing (TET) which is fixed to the cecum with clips under endoscopic guidance.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical response	reduction in the Mayo score of =3 points and =30% from baseline, with a decrease in the rectal bleeding subscore of =1 point or a subscore of =1	2 weeks after FMT
Secondary	clinical remission, safety and progression of disease	clinical remission: Mayo score = 2, with no subscore > 1; progression of disease: measured by initiation of anti-TNFa or colectomy. Adverse event severity and relatedness was graded using NIH criteria.	2 weeks after FMT