NCT03621033

Brief Summary

Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment. The aim of this study was to evaluate the methodology, efficiency, feasibility and safety of using transparent cap-assisted endoscopy for colon TET implantation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

August 10, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

August 5, 2018

Last Update Submit

February 22, 2020

Conditions

Colonic Transendoscopic Enteral Tubing

Keywords

transendoscopic enteral tubingMicrobiota Transplantationtransparent cap-assisted colonoscopy

Outcome Measures

Primary Outcomes (1)

  • The second cecal intubation time

    Record the time of colonoscopy from the anus to the ileal flap in the second insertion.

    one day

Secondary Outcomes (6)

  • Adverse events rate

    All patients were followed up from date of intubation to one mouth after discharge

  • TET success rate

    one day

  • Maximum insertion pain score

    one day

  • Retention time of tube

    three month

  • Tubing time

    one day

  • +1 more secondary outcomes

Study Arms (2)

non-transparent cap-assisted endoscopic intubation

OTHER

we do not use transparent cap-assisted endoscopic intubation.

Procedure: colonic transendoscopic enteral tubing

transparent cap-assisted endoscopic intubation

OTHER

we use transparent cap-assisted endoscopic intubation in the second insertion.

Procedure: colonic transendoscopic enteral tubing

Interventions

colonic transendoscopic enteral tubingPROCEDURE

The procedure colonic transendoscopic enteral tubing is as follows:The TET tube was inserted into the ileocecal junction through the endoscopy channel at the first time of the cecal intubation after examination and evaluation of the whole colon. Then, the colonoscope was removed from the colon while the TET tube was maintained at the ileocecal junction. Then the endoscopy was inserted into the ileocecum again for affixing the TET tube to cecum with titanium clips.

non-transparent cap-assisted endoscopic intubationtransparent cap-assisted endoscopic intubation

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diseases requiring total colonic administration and fecal microbiota transplantation.
  • Patients and healthy Volunteers with the need to sample in deep colon .
  • Age \> 7 years.
  • Must be able to Colonic Transendoscopic Enteral Tubing 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.

You may not qualify if:

  • Data was not recorded as required; Before and after implantation is not the same physician operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fmt-Dt-N-27/1350

Nanjing, Jiangsu, 210011, China

RECRUITING

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

Nanjing, Jiangsu, 210011, China

RECRUITING

Related 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.

    PMID: 27556065RESULT

  • 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.

    PMID: 22228167RESULT

Study Officials

  • Faming Zhang, MD; PhD

    Nanjing Medical University

    STUDY CHAIR

Central Study Contacts

Faming Zhang, MD; PhD

CONTACT

086-25-58509883fzhang@njmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Gastroenterology

Study Record Dates

First Submitted

August 5, 2018

First Posted

August 8, 2018

Study Start

August 10, 2018

Primary Completion

May 10, 2020

Study Completion

May 10, 2020

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

CN(2)