Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dynamic Changes of Gut Microbiota in UC After FMT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949257
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Nanjing Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Device: colonic transendoscopic enteral tubing Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Dynamic Changes of Gut Microbiota in Patients With Ulcerative Colitis After Fecal Transplantation
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: colonic TET and FMT
gut microbiota will be collected through the colonic TET after FMT
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.
Other Name: fecal microbiota transplantation




Primary Outcome Measures :
  1. changes of gut microbiota [ Time Frame: 7 days ]
    gut microbiota will be collected through the colonic TET


Secondary Outcome Measures :
  1. frequency of defecation [ Time Frame: 7 days ]
    the frequency of defecation in UC patients will be recorded



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949257


Contacts
Layout table for location contacts
Contact: faming zhang, MD; PhD 086-25-58509883 fzhang@njmu.edu.cn
Contact: min dai, MD; PhD 086-25-58509884 daimin@njmu.edu.cn

Locations
Layout table for location information
China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Investigators
Layout table for investigator information
Study Chair: faming zhang, MD; PhD The Second Hospital of Nanjing Medical University
Publications:
Layout table for additonal information
Responsible Party: The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03949257    
Other Study ID Numbers: FMT-TET-190507
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Second Hospital of Nanjing Medical University:
transendoscopic enteral tubing
gut microbiota
ulcerative colitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases