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New treatment option for Ulcerative Colitis
Official title Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population
ClinicalTrials.gov ID: NCT07401680
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or older
- Able to provide informed consent
- Established UC diagnosis through standard endoscopic and histologic criteria
- Active UC
- Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the...
You likely can't join if
- Severe UC requiring hospitalization
- Crohn's disease or indeterminate colitis
- Irritable bowel syndrome
- Intestinal infection within 4 weeks of enrollment
- Evidence of toxic megacolon or gastrointestinal perforation on imaging
- Planned colectomy
See the full eligibility criteria
- 18 years of age or older
- Able to provide informed consent
- Established UC diagnosis through standard endoscopic and histologic criteria
- Active UC
- Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial
- Willing and able to comply with all required study procedures
- Severe UC requiring hospitalization
- Crohn's disease or indeterminate colitis
- Irritable bowel syndrome
- Intestinal infection within 4 weeks of enrollment
- Evidence of toxic megacolon or gastrointestinal perforation on imaging
- Planned colectomy
- Abdominal surgery within 60 days of enrollment
- Neutropenia with absolute neutrophil count \<0.5 x 109/L
- Peripheral white blood cell count \> 35.0 x 109/L and fever (\>38C)
- Planned or actively taking another investigational product
- Uncontrolled medical conditions such as psychiatric disorders or substance abuse
- Severe underlying disease such that the patient is not expected to survive for at least 30 days
- Pregnancy or breastfeeding
- Unwilling to discontinue non-dietary probiotic
- Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study
- FMT for any reason within 6 months of enrollment
- Investigator's judgement that enrolment is not in the best interest of the patient
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.