NCT02560727

Brief Summary

No technique by placing a tube through anus into cecum for whole colon administration. This study aimed to evaluate the feasibility, safety, and efficacy of transendoscopic enteral tubing (TET) in fecal microbiota transplantation (FMT) through whole colon.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

September 21, 2015

Last Update Submit

September 24, 2015

Conditions

Inflammatory Bowel Diseases

Keywords

Inflammatory Bowel DiseasesFecal Microbiota Transplantationtransendoscopic enteral tubing

Outcome Measures

Primary Outcomes (1)

  • durability of clinical remission

    The durability of clinical remission (days) after Fecal Microbiota Transplantation procedure by TET.Defined as Montreal score S0 (clinical remission)

    One year

Secondary Outcomes (1)

  • Patients with worsened disease

    one year

Other Outcomes (1)

  • Adverse events

    one year

Study Arms (2)

colonoscope via of FMT

FMT pathway is colonoscope

Device: colonoscope

Transendoscopic enteral tubing

FMT was performed via TET tube

Device: transendoscopic enteral tubing

Interventions

transendoscopic enteral tubingDEVICE

Investigators designed transendoscopic enteral tubing (TET).The enteral segment of the tube is fixed in the ileocecum with distal segment fixed buttocks. The tube was used for FMT and colonic local administration

Also known as: TET
Transendoscopic enteral tubing
colonoscopeDEVICE

FMT via colonoscope is the most common approach.

colonoscope via of FMT

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A prospective study was conducted at the Digestive Medicine Center of the Second Affiliated Hospital of Nanjing Medical University from October 2014 to June 2016. All recruited cases met the including criteria: aged 10-70 yr, suitable for endoscopy, and agreed to undergo FMT and TET

You may qualify if:

  • Mild to moderate ulcerative colitis (Montreal classification)

You may not qualify if:

  • Diagnosed as ulcerative colitis first time.
  • No history of using Biologic, immunomodulatory therapy or corticosteroid therapy.
  • With contraindication of endoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (4)

  • Youngster I, Russell GH, Pindar C, Ziv-Baran T, Sauk J, Hohmann EL. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA. 2014 Nov 5;312(17):1772-8. doi: 10.1001/jama.2014.13875.

    PMID: 25322359BACKGROUND

  • van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.

    PMID: 23323867BACKGROUND

  • 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.

    PMID: 25168749BACKGROUND

  • Ding X, Li Q, Li P, Zhang T, Cui B, Ji G, Lu X, Zhang F. Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis. Drug Saf. 2019 Jul;42(7):869-880. doi: 10.1007/s40264-019-00809-2.

    PMID: 30972640DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Colonoscopes

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopes, GastrointestinalEndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Officials

  • Faming Zhang, MD,PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, MD,PhD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Gastroenterology

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 25, 2015

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2016

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

CN(1)