Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population

ConditionsUlcerative Colitis Inflammatory Bowel Diseases Clostridioides Difficile Infection

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Alberta

About this trial

This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

Able to provide informed consent

Established UC diagnosis through standard endoscopic and histologic criteria

Active UC

Disqualifiers

Severe UC requiring hospitalization

Crohn's disease or indeterminate colitis

Irritable bowel syndrome

Intestinal infection within 4 weeks of enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

Lyophilized Fecal Microbiota Transplantation (LFMT)
Other intervention
LFMT by oral capsules
Placebo
Other intervention
Placebo capsules does not contain FMT

Treatment groups

85 Participants

are divided into 4 treatment groups

Group A: Adjunct therapy group (LFMT)Experimental treatment 1 intervention

Group B: Adjunct therapy group (Placebo)Placebo comparator 1 intervention

Group C: Co-Administration therapy group (LFMT)Experimental treatment 1 intervention

Group D: Co-Administration therapy group (Plcebo)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

Steroid-free endoscopic remission

Steroid-free endoscopic remission is defined as either 1. Mayo endoscopy score (MES)= 0 OR 2. MES=1 + FC \<150 µg/g

Time frame

At 8 weeks

Secondary outcomes

Serious adverse events [SAE]

SAEs including infections attributable to FMT, hospitalization due to UC exacerbation or complications related to FMT, or colectomy due to UC

Time frame

up to week 24 or at time of withdrawal

Adverse outcomes

Adverse outcomes, including nausea, vomiting, worsening diarrhea or abdominal pain

Time frame

up to week 24 or upon withdrawal

Quality of Life- sIBDQ

Changes in health-related quality of life measures using the short IBD questionnaire (sIBDQ)

Time frame

Baseline to 8 weeks and 24 weeks

Quality of Life- WPAI-IBD

Changes in health-related quality of life measures using the work productivity and activity impairment questionnaire (WPAI-IBD)

Time frame

Baseline to 8 weeks and weeks 24

Other outcomes

Recruitment rate

Evaluation of rate of participant recruitment

Time frame

Study start to the end of recruitment

Consent rate

Evaluation of rate of participant consent to participate

Time frame

Study start to the end of recruitment

Symptom remission

Symptom remission, defined as partial Mayo score \<2 with no individual subscore \>1

Time frame

8 weeks and 24 weeks

Symptom response

Symptom response, defined as reduction in partial Mayo score by \>2 points from baseline and \>30% from baseline and decrease in rectal bleeding score \>1 point from baseline

Time frame

At weeks 8 and 24

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

University of Calgary

Collaborator

Source ClinicalTrials.gov

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