Dynamic Changes of Gut Microbiota in UC After FMT

NCT ID: NCT03949257

Last Updated: 2019-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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colonic TET and FMT

gut microbiota will be collected through the colonic TET after FMT

Group Type EXPERIMENTAL

colonic transendoscopic enteral tubing

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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fecal microbiota transplantation

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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faming zhang, MD; PhD

Role: STUDY_CHAIR

The Second Hospital of Nanjing Medical University

Locations

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Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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faming zhang, MD; PhD

Role: CONTACT

086-25-58509883

min dai, MD; PhD

Role: CONTACT

086-25-58509884

References

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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.

Reference Type BACKGROUND
PMID: 27556065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22228167 (View on PubMed)

Other Identifiers

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FMT-TET-190507

Identifier Type: -

Identifier Source: org_study_id

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