Feasibility and Safety of Ttransendoscopic Enteral Tubing in Mid-gut

A transendoscopic enteral tubing (TET ) tube was inserted into mid-gut through the nasal orifice and fixed on the pylorus wall by one tiny titanium endoscopic clip under anesthesia. This study aimed to evaluate the feasibility and safety of TET in mid-gut .

Study Overview

• Status: Unknown
• Conditions: Transendoscopic Enteral Tubing
• Intervention / Treatment: Procedure: transendoscopic enteral tubing in mid-gut

Detailed Description

In recent years, fecal microbiota transplantation (FMT) has gained appeal as a therapeutic option worldwide. Traditionally, microbiota can be administered through the upper-gut, the mid-gut, and the lower-gut pathways. FMT via colonoscopy is a classic approach, but in our previous study on ulcerative colitis, those patients have difficulty to maintain the infused microbiota suspension for enough time through this way. Thus, the investigators designed the colonic transendoscopic enteral tubing (TET) technology, which made whole-colon administration of treatment and repeat FMTs possible. However, some patients are resistant to undergo bowel preparation for colonoscopy or some are not suitable for colonic delivering way. Therefore, mid-gut delivering way is an important option for those patients. In previous researches on FMT for Crohn's disease, patients and physician faced the similar problem that some patients need repeat FMT during hospitalization, and some may need enteral nutrition at the same time. In order to have a quicker and more convenient placement of mid-gut/nasal-jejunal TET tube than traditional methods, the investigators designed a novel mid-gut TET technique without further confirmation for the location of tube in gut by X-ray or other medical devices after the endoscopic procedure. This study aimed to evaluate the feasibility, safety, and value of the mid-gut TET technique.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Mild to moderate inflammatory bowel disease (Montreal classification) or suitability for endoscopy, and consented to undergo TET placement for their diseases and conditions

Exclusion Criteria:

No history of using Biologic, immunomodulatory therapy or corticosteroid therapy.

With contraindication of endoscopy. Pregnant or lactating female

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: transendoscopic enteral tubing in mid-gut; A TET tube was inserted into mid-gut through the nasal orifice and fixed on the pylorus wall by one tiny titanium endoscopic clip under anesthesia. The feasibility, safety, success rate, and satisfaction with TET placement were evaluated for enteral nutrition or fecal microbiota transplantation.	Procedure: transendoscopic enteral tubing in mid-gut; A TET tube was inserted into mid-gut through the nasal orifice and fixed on the pylorus wall by one tiny titanium endoscopic clip under anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate	the success rate of of the TET procedure	All patients were followed up from date of intubation to one mouth after discharge
adverse events rate	Procedure-related and tube-related adverse events after procedure	All patients were followed up from date of intubation to one mouth after discharge

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University

Publications and helpful links

General Publications

• Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.
• Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: November 4, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: fecal microbiota transplantation; endoscopy; enteral nutrition; transendoscopic enteral tubing; mid-gut; nasal-jejunal tube
• Other Study ID Numbers: TET-CN-151001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No