Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis

Ulcerative Colitis Flare Clinical Trial

— FUEL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04926103
• Other study ID #: FUEL001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: May 1, 2029

Study information

• Verified date: March 2022
• Source: Hamilton Health Sciences Corporation
• Contact: Melanie A Wolfe, CCRP
• Phone: 9055212100
• Email: wolfe[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 1, 2029
• Est. primary completion date: October 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged 18 or over

2. Active UC defined as a Mayo score (7) >3

3. A Mayo endoscopic score (7) >0

4. 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:

1. Participating in another intervention study for UC

2. Unable to give informed consent

3. Severe comorbid medical illness

4. Severe UC requiring hospitalization.

5. 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.

6. Antibiotic therapy in the last 30 days.

7. Pregnant women.

8. Patients with clinically significant hepatic dysfunction at the time of screening: ALT > 5 times the upper normal range.

9. Patients with clinically significant renal dysfunction at the time of screening: serum creatinine > 300 µmol/L

10. Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis Flare

Intervention

Other:
• Fecal Microbiota transplant (FMT)
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

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences / McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	9 weeks
Primary	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	3 years
Secondary	Efficacy of FMT at in inducing histological remission in active UC	Histological remission with no active inflammation on rectal and sigmoid biopsies	9 weeks
Secondary	Efficacy of FMT at relieving PRO2 symptoms	A score of zero on the first two questions of the Mayo Score	9 weeks
Secondary	Efficacy of FMT at improving Quality of life	Improvement in quality of life from baseline measured by EQ5D	9 weeks and 3 years
Secondary	Adverse effects of FMT	Adverse effects associated with FMT therapy	3 years
Secondary	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	9 weeks
Secondary	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	9 weeks