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Compares treatment options for Ulcerative Colitis
Official title LFMT vs Placebo in New Biologic Start for Ulcerative Colitis
ClinicalTrials.gov ID: NCT05327790
What this study is testing
What is Lyophilized fecal microbiota (LFMT)?
Lyophilized fecal microbiota (LFMT) is an investigational medicine, being studied as a potential treatment for ulcerative colitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 18 years of age or older but less than 75 years of age
- Able to provide informed consent
- Established ulcerative colitis diagnosis determined by a physician through standard endoscopic and histologic criteria
- Active UC defined as total Mayo score between 6-12 AND Mayo endoscopic sub-score \>1 with disease that extends 15 cm or more from the anal verge
- Selected by treating physician for initiation of biologic treatment with either vedolizumab or ustekinumab. Patients must be:
You likely can't join if
- Severe UC requiring hospitalization
- Indeterminate colitis
- Evidence of or treatment for C difficile infection or other intestinal pathogen, including CMV, within 4 weeks prior to enrollment
- Evidence of toxic megacolon or gastrointestinal perforation on imaging
- Abdominal surgery within the past 60 days
- Neutropenia with absolute neutrophil count \<0.5 x 109/L
See the full eligibility criteria
- 18 years of age or older but less than 75 years of age
- Able to provide informed consent
- Established ulcerative colitis diagnosis determined by a physician through standard endoscopic and histologic criteria
- Active UC defined as total Mayo score between 6-12 AND Mayo endoscopic sub-score \>1 with disease that extends 15 cm or more from the anal verge
- Selected by treating physician for initiation of biologic treatment with either vedolizumab or ustekinumab. Patients must be:
- Biologic naive; OR
- Have failed anti-TNF, anti-integrin, anti IL12/23 or oral small molecules
- 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
- Indeterminate colitis
- Evidence of or treatment for C difficile infection or other intestinal pathogen, including CMV, within 4 weeks prior to enrollment
- Evidence of toxic megacolon or gastrointestinal perforation on imaging
- Abdominal surgery within the past 60 days
- Neutropenia with absolute neutrophil count \<0.5 x 109/L
- Peripheral white blood cell count \> 35.0 x 109/L and fever (\>38 degrees Celsius)
- 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
- Pregnant or lactating
- Unwilling to discontinue non-dietary probiotic
- Antibiotic use in the past 30 days or anticipated need for systemic antibiotic use during study
- FMT within 3 months prior to enrollment
- Use of the following medications:
- rectal/topical therapy within 2 weeks of screening
- cyclosporine, tacrolimus or thalidomide within 4 weeks of screening
- tofacitinib within 4 weeks of screening
- adalimumab or infliximab within 8 weeks of screening
- vedolizumab within 8 weeks of screening
- ustekinumab within 12 weeks of screening
- prednisone \> 30 mg/d
- Investigator deems enrolment in the study is not in the best interest of the patient
The study team makes the final eligibility decision.
Where it's taking place
- 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.