NCT03078803

Brief Summary

To determine the efficacy and safety of serial FMT at inducing and maintaining clinical and endoscopic response in patients with mild to moderate Crohn's disease

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2017

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

January 12, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

March 28, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

4.2 years

First QC Date

January 12, 2017

Last Update Submit

September 2, 2022

Conditions

Crohn Disease

Keywords

fecal transplantinflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

  • Clinical and Endoscopic Remission

    Harvey Bradshaw Index \<5 and Simple endoscopic score \<5

    Week 8

Secondary Outcomes (7)

  • Clinical response

    Week 8

  • Clinical remission

    Week 8

  • Endoscopic response

    Week 8

  • Endoscopic remission

    Week 8

  • Quality of Life 1

    Week 8

  • +2 more secondary outcomes

Study Arms (2)

Fecal microbiota transplant

EXPERIMENTAL

Transfer of healthy human gut bacteria

Biological: Fecal Microbiota Transplant (FMT)

Placebo

PLACEBO COMPARATOR

Water

Biological: Placebo

Interventions

Fecal Microbiota Transplant (FMT)BIOLOGICAL

FMT delivered by colonoscopy and oral capsules

Also known as: FMT
Fecal microbiota transplant
PlaceboBIOLOGICAL

Transfer of water only

Placebo

Eligibility Criteria

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

You may qualify if:

  • mild to moderate ileal, ileo-colonic or colonic Crohns disease
  • active ileal and/or colonic disease on endoscopy with or without elevated inflammatory markers i.e. C-reactive protein \>8mg/L, elevated fecal calprotectin \>250 ug/g
  • If applicable, meds stable as follows: 5-ASA for 4 weeks, prednisone up to 20mg QD for 4 weeks, budesonide up to 6mg QD for 4 weeks, azathioprine, 6-MP and methotrexate for 12 weeks
  • Use of effective contraception

You may not qualify if:

  • Antibiotic exposure within 30 days and probiotic exposure within 14 days
  • topical inflammatory bowel disease therapy within 2 weeks
  • active perianal disease
  • requirement for concurrent antibiotic therapy
  • SES-CD score \<5
  • severe CD HBI \>25 or need for hospitalization
  • abdominal abscess
  • extensive colonic resection, subtotal or total colectomy
  • ileostomy, colostomy, known fixed symptomatic stenosis or complex fistulae
  • evidence of or treatment for C. difficile or other intestinal pathogen including Cytomegalovirus within 28 days
  • requiring or expected to require surgical intervention
  • history or evidence of adenomatous colonic polyps not removed
  • history of evidence of colonic dysplasia
  • active substance abuse or psychiatric problems that may interfere with study
  • chronic Hep B, C, or HIV infection
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Foothills Hospital

Calgary, Alberta, T2N2T9, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2X8, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

Related Publications (1)

  • Kao D, Wong K, Jijon H, Moayyedi P, Franz R, McDougall C, Hotte N, Panaccione R, Semlacher E, Kroeker KI, Peerani F, MacDonald KV, Xu H, Narula N, Turbide C, Marshall DA, Madsen KL. Preliminary Results From a Multicenter, Randomized Trial Using Fecal Microbiota Transplantation to Induce Remission in Patients With Mild-to-Moderate Crohn's Disease. Am J Gastroenterol. 2024 Nov 12;120(6):1334-1344. doi: 10.14309/ajg.0000000000003196.

    PMID: 39530534DERIVED

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Dina Kao, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2017

First Posted

March 13, 2017

Study Start

March 28, 2017

Primary Completion

June 21, 2021

Study Completion

August 29, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)