Dynamic Changes of Gut Microbiota in UC After FMT

Ulcerative Colitis Clinical Trial

Official title:

Dynamic Changes of Gut Microbiota in Patients With Ulcerative Colitis After Fecal Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03949257
• Other study ID #: FMT-TET-190507
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: May 2019
• Source: The Second Hospital of Nanjing Medical University
• Contact: faming zhang, MD; PhD
• Phone: 086-25-58509883
• Email: fzhang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective study to investigate the dynamic changes of gut microbiota through colonic transendoscopic enteral tubing in patients with ulcerative colitis after fecal microbiota transplantation.

Description:

Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment. This tube also can serve as a medium for collecting gut microbiota. Fecal Microbiota Transplantation (FMT) was identified to be promising for ulcerative colitis (UC). This study aims to investigate the dynamic changes of gut microbiota in patients with UC after FMT.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients were diagnosed with mild or moderate ulcerative colitis.

• Patients need colonic TET and FMT

• Must be able to colonic TET and no contraindication by endoscopic examination, consent colon TET implantation and not associated with severe intestinal lesions such as fistula, stenosis, complex perianal lesions, severe ileocecal or ascending colon lesions resulting in no proper site for titanium clip fixation.

• Age > 7 years old and < 65 years old

Exclusion Criteria:

• gut microbiota was not collected successfully

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• colonic transendoscopic enteral tubing
Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment.

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28. — View Citation

Westwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: a systematic review and meta-analysis. Dis Colon Rectum. 2012 Feb;55(2):218-25. doi: 10.1097/DCR.0b013e31823461ef. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of gut microbiota	gut microbiota will be collected through the colonic TET	7 days
Secondary	frequency of defecation	the frequency of defecation in UC patients will be recorded	7 days