Back to results

Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis (FUEL)

Primary Purpose

Ulcerative Colitis Flare

Status

Not yet recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Fecal Microbiota transplant (FMT)

About this trial

This is an interventional treatment trial for Ulcerative Colitis Flare

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged 18 or over
Active UC defined as a Mayo score (7) >3
A Mayo endoscopic score (7) >0
Females of child-bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance

Exclusion Criteria:

Participating in another intervention study for UC
Unable to give informed consent
Severe comorbid medical illness
Severe UC requiring hospitalization.
Increase in medical therapy for UC in the last 12 weeks. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior to randomization. Relapse on a stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. Stable intake of probiotic therapy also permitted.
Antibiotic therapy in the last 30 days.
Pregnant women.
Patients with clinically significant hepatic dysfunction at the time of screening: ALT > 5 times the upper normal range.
Patients with clinically significant renal dysfunction at the time of screening: serum creatinine > 300 µmol/L
Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.

Sites / Locations

Hamilton Health Sciences / McMaster University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open label FMT therapy

Arm Description

FMT from a related or unrelated healthy donor screened for known communicable disease

Outcomes

Primary Outcome Measures

Efficacy of FMT donors at inducing UC remission

Suitability of FMT donors at inducing remission in active UC (remission defined as a Mayo score (7) < 3 with an endoscopic Mayo score = 0 at the end of 8 weeks of FMT).

Efficacy of FMT at maintaining remission in UC

Maintenance of remission of UC after three years in those who achieve initial remission with FMT. This is defined as no relapse over three years that requires any medical therapy other than more intense FMT therapy

Secondary Outcome Measures

Efficacy of FMT at in inducing histological remission in active UC

Histological remission with no active inflammation on rectal and sigmoid biopsies

Efficacy of FMT at relieving PRO2 symptoms

A score of zero on the first two questions of the Mayo Score

Efficacy of FMT at improving Quality of life

Improvement in quality of life from baseline measured by EQ5D

Adverse effects of FMT

Adverse effects associated with FMT therapy

Stool microbiota predicting FMT success

Comparison of stool microbiota evaluated by 16s RNA and metagenomics in those achieving remission with FMT versus those that are not successful

Mucosal microbiota predicting FMT success

Comparison of mucosal microbiota evaluated by 16s RNA and metagenomics in those achieving remission with FMT versus those that are not successful

Full Information

NCT ID

NCT04926103

First Posted

May 12, 2021

Last Updated

March 15, 2022

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT04926103

Brief Title

Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis

Acronym

FUEL

Official Title

Screening Donors for a Fecal Microbiota Transplant Program in Ulcerative Colitis: Evaluating Efficacy and Long-term Effects. The FUEL Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

October 1, 2028 (Anticipated)

Study Completion Date

May 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hamilton Health Sciences Corporation

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. It is important to give UC patients participating in RCTs stool that has been demonstrated to be effective in some patients. We therefore propose to conduct an open label study in patients with active UC to ensure new donors are effective at inducing remission in some patients. Patients that have FMT will relapse within 18 months (PubMed ID: 25857665) although further FMT therapy induces remission so it is possible that maintenance FMT will result in long term remission, but this needs evaluation. We will therefore follow UC patients that have responded to FMT long term in this open label study.

Detailed Description

This is an open label study with all UC patients receiving FMT. Up to 200 patients with active UC will be recruited to the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis Flare

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

This is an open label study with all UC patients receiving FMT.

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Open label FMT therapy

Arm Type

Experimental

Arm Description

FMT from a related or unrelated healthy donor screened for known communicable disease

Intervention Type

Other

Intervention Name(s)

Fecal Microbiota transplant (FMT)

Intervention Description

Patients will come once a week for FMT for 8 weeks. FMT is the administration of the supernatant component of stool and water mixture from a healthy relative or an unrelated donor. The donor's stool and blood is rigorously screened to exclude known communicable diseases. Those that achieve remission with FMT will have the option of continuing FMT once per month for 3 years

Primary Outcome Measure Information:

Title

Efficacy of FMT donors at inducing UC remission

Description

Suitability of FMT donors at inducing remission in active UC (remission defined as a Mayo score (7) < 3 with an endoscopic Mayo score = 0 at the end of 8 weeks of FMT).

Time Frame

9 weeks

Title

Efficacy of FMT at maintaining remission in UC

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Efficacy of FMT at in inducing histological remission in active UC

Description

Histological remission with no active inflammation on rectal and sigmoid biopsies

Time Frame

9 weeks

Title

Efficacy of FMT at relieving PRO2 symptoms

Description

A score of zero on the first two questions of the Mayo Score

Time Frame

9 weeks

Title

Efficacy of FMT at improving Quality of life

Description

Improvement in quality of life from baseline measured by EQ5D

Time Frame

9 weeks and 3 years

Title

Adverse effects of FMT

Description

Adverse effects associated with FMT therapy

Time Frame

3 years

Title

Stool microbiota predicting FMT success

Description

Comparison of stool microbiota evaluated by 16s RNA and metagenomics in those achieving remission with FMT versus those that are not successful

Time Frame

9 weeks

Title

Mucosal microbiota predicting FMT success

Description

Comparison of mucosal microbiota evaluated by 16s RNA and metagenomics in those achieving remission with FMT versus those that are not successful

Time Frame

9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged 18 or over Active UC defined as a Mayo score (7) >3 A Mayo endoscopic score (7) >0 Females of child-bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance Exclusion Criteria: Participating in another intervention study for UC Unable to give informed consent Severe comorbid medical illness Severe UC requiring hospitalization. Increase in medical therapy for UC in the last 12 weeks. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior to randomization. Relapse on a stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. Stable intake of probiotic therapy also permitted. Antibiotic therapy in the last 30 days. Pregnant women. Patients with clinically significant hepatic dysfunction at the time of screening: ALT > 5 times the upper normal range. Patients with clinically significant renal dysfunction at the time of screening: serum creatinine > 300 µmol/L Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Melanie A Wolfe, CCRP

Phone

9055212100

Ext

22060

wolfe@hhsc.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Aida Fernandes, MBA

Phone

289-921-6483

fernaa19@mcmaster.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Moayyedi, MD

Organizational Affiliation

HHSC/McMaster

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamilton Health Sciences / McMaster University

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Approach investigator to ask for anonymized dataset

IPD Sharing Time Frame

Data will be available after study completion - estimated 7 years

IPD Sharing Access Criteria

Any researcher evaluating the efficacy of FMT in ulcerative colitis

Citations:

PubMed Identifier

25857665

Citation

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.

Results Reference

background

Learn more about this trial

Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis

We'll reach out to this number within 24 hrs