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NCT Number: NCT04926103

Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis

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.

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Key information

Conditions

Ulcerative Colitis Flare

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fecal Microbiota Transplant (FMT)

Other

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 outcomes

  1. Efficacy of FMT donors at inducing UC remission

    Time frame: 9 weeks

    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).

  2. Efficacy of FMT at maintaining remission in UC

    Time frame: 3 years

    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 outcomes

  1. Efficacy of FMT at in inducing histological remission in active UC

    Time frame: 9 weeks

    Histological remission with no active inflammation on rectal and sigmoid biopsies

  2. Efficacy of FMT at relieving PRO2 symptoms

    Time frame: 9 weeks

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

  3. Efficacy of FMT at improving Quality of life

    Time frame: 9 weeks and 3 years

    Improvement in quality of life from baseline measured by EQ5D

  4. Adverse effects of FMT

    Time frame: 3 years

    Adverse effects associated with FMT therapy

  5. Stool microbiota predicting FMT success

    Time frame: 9 weeks

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

  6. Mucosal microbiota predicting FMT success

    Time frame: 9 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Aida Fernandes, MBA

CONTACT

[email protected]

289-921-6483

Melanie A Wolfe, CCRP

CONTACT

[email protected]

9055212100 ext. 22060

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: FUEL

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Jun 14, 2021
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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