NCT02998112

Brief Summary

To indicate the efficacy of Fecal microbiota transplantation (FMT) for the treatment of Ulcerative colitis (UC), The investigators design a multicenter, randomized controlled trial to perform FMT through colonic transendoscopic enteral tubing (TET) way, and evaluate the efficacy and safety of FMT for patients with moderate or severe UC.

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
188

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_4

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

December 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

December 13, 2016

Last Update Submit

December 15, 2016

Conditions

Ulcerative Colitis

Keywords

fecal microbiota transplantationUlcerative colitis

Outcome Measures

Primary Outcomes (2)

  • Clinical remission

    Total Mayo score less than 2 and no signal item more than 1

    12 weeks

  • Clinical improvement

    Total Mayo score decreased more than 3 or decreased more than 30%

    12 weeks

Secondary Outcomes (1)

  • Intestinal microbiota changing

    12 weeks

Study Arms (2)

control

PLACEBO COMPARATOR

5-ASA 4g/day enema through TET for 1 week; 200ml saline infusion through TET for 3 times every other day in one week

Drug: Saline

Study group

EXPERIMENTAL

5-ASA 4g/day enema through TET for 1 week; 200ml fecal microbiota suspension infusion through TET for 3 times every other day in one week

Drug: fecal microbiota transplantation

Interventions

fecal microbiota transplantationDRUG

Fecal microbiota which was purified from fresh stool defecated by a healthy donor

Study group
SalineDRUG
control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active, moderate to severe severity (Mayo score more than 6)
  • Safety using history of 5-ASA.
  • Able to undergo endoscopy examination.

You may not qualify if:

  • Immunosuppressive drugs and glucocorticoids using in 4 weeks
  • Antibiotic using in 7 days
  • High risk of toxic megacolon
  • Colon cancer or neoplasia in pathophysiology
  • Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)

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)

  • 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.

    PMID: 26363929RESULT

  • 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: 25168749RESULT

  • Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.

    PMID: 25857665RESULT

  • Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.

    PMID: 25836986RESULT

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota TransplantationSodium Chloride

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Gastroenterology

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 20, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

December 20, 2016

Record last verified: 2016-12

Locations

CN(1)