Fecal Microbiota Transplant for Ulcerative Colitis
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Alberta
Prior Safety Data
Trial Summary
What is the purpose of this trial?To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
What data supports the idea that Fecal Microbiota Transplant for Ulcerative Colitis is an effective treatment?The available research shows that Fecal Microbiota Transplant (FMT) can be effective for treating ulcerative colitis. One study found that oral FMT led to remission in some patients, with one donor achieving 100% success. Another study demonstrated that high-intensity FMT was effective in treating active ulcerative colitis. These findings suggest that FMT can be a promising treatment option for this condition.168910
Is fecal microbiota transplant a promising treatment for ulcerative colitis?Fecal microbiota transplant (FMT) is a promising treatment for ulcerative colitis because it has shown potential to help patients achieve remission, especially when other treatments fail. Some studies and case reports suggest that FMT can improve symptoms by changing the gut bacteria in patients with ulcerative colitis.23457
Do I have to stop taking my current medications to join the trial?Yes, you may need to stop certain medications. You cannot use rectal/topical therapy within 2 weeks, cyclosporine, tacrolimus, or thalidomide within 4 weeks, tofacitinib within 4 weeks, adalimumab or infliximab within 8 weeks, vedolizumab within 8 weeks, ustekinumab within 12 weeks, or prednisone over 30 mg/day before screening. You also need to stop non-dietary probiotics and antibiotics 30 days before the trial.
What safety data exists for fecal microbiota transplant in ulcerative colitis?Several studies have evaluated the safety of fecal microbiota transplantation (FMT) for ulcerative colitis. These include randomized, double-blind, placebo-controlled trials and pilot studies that assess the procedure, effectiveness, and safety of FMT. The studies explore different delivery methods, such as oral lyophilized FMT and frozen, encapsulated oral FMT, and examine both short-term and long-term safety and feasibility. Overall, FMT is considered a promising treatment strategy, but variations in study design and methodology can affect safety outcomes.14689
Eligibility Criteria
This trial is for adults aged 18-75 with ulcerative colitis, confirmed by a doctor using standard tests. Participants must have active symptoms and be starting vedolizumab or ustekinumab treatment but can't have used certain medications recently. Women who can bear children must use contraception during the trial.Inclusion Criteria
My ulcerative colitis was confirmed by a doctor using specific tests.
I am between 18 and 75 years old.
My ulcerative colitis is active, with a moderate to severe score and extends beyond 15 cm from the anal verge.
Exclusion Criteria
My condition is diagnosed as indeterminate colitis.
My white blood cell count is high and I have had a fever over 38°C.
I have been hospitalized for severe ulcerative colitis.
I have not taken antibiotics in the last 30 days and do not expect to need any during the study.
I have not had a fecal microbiota transplant in the last 3 months.
I take more than 30 mg of prednisone daily.
Treatment Details
The study is testing LFMT against a placebo in patients beginning biologic treatments for ulcerative colitis to see which is safer and more effective. Patients will either receive this new fecal microbiota therapy or a dummy treatment as they start their prescribed medication.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: LFMT capsules + vedolizumabExperimental Treatment1 Intervention
The initial loading dose is 15 capsules, administered on day 0, in the clinic under direct observation, followed by 5 capsules daily starting on day 1 for 8 weeks at home. All subsequent doses will be dispensed to participants.
Group II: LFMT capsules + ustekinumabExperimental Treatment1 Intervention
The initial loading dose is 15 capsules, administered on day 0, in the clinic under direct observation, followed by 5 capsules daily starting on day 1 for 8 weeks at home. All subsequent doses will be dispensed to participants.
Group III: Placebo capsules + vedolizumabPlacebo Group1 Intervention
The placebo capsules will appear identical to the LFMT capsules; however, the capsules will contain 2 ingredients: trehalose and neusilin, which are components in LFMT capsules.
Group IV: Placebo capsules + ustekinumabPlacebo Group1 Intervention
The placebo capsules will appear identical to the LFMT capsules; however, the capsules will contain 2 ingredients: trehalose and neusilin, which are components in LFMT capsules.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Alberta HospitalEdmonton, Canada
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Who is running the clinical trial?
University of AlbertaLead Sponsor
References
[A pilot study of treating ulcerative colitis with fecal microbiota transplantation]. [2022]To explore the procedure, effectiveness and safety of fecal microbiota transplantation (FMT) in patients with ulcerative colitis (UC).
Low Level Engraftment and Improvement following a Single Colonoscopic Administration of Fecal Microbiota to Patients with Ulcerative Colitis. [2022]Fecal microbiota transplantation (FMT) is an investigational treatment for diseases thought to involve alterations in the intestinal microbiota including ulcerative colitis (UC). Case reports have described therapeutic benefit of FMT in patients with UC, possibly due to changes in the microbiota. We measured the degree to which the transplanted microbiota engraft following FMT in patients with UC using a donor similarity index (DSI).
Failure of Fecal Microbiota Transplantation in a Three-Year-Old Child with Severe Refractory Ulcerative Colitis. [2022]Fecal microbiota transplantation (FMT) is a treatment designed to correct gut dysbiosis by administration of feces from a healthy volunteer. It is still unclear whether FMT for children with ulcerative colitis (UC) is effective or hazardous. Here we describe a young patient to have received FMT for UC. A three-year-old girl was admitted to our hospital with severe active UC, and treated with aminosalicylates and various immunosuppressive drugs. As remission was not achieved, we decided to try FMT before colectomy. We administered donor fecal material a total of six times by retention enema (×2) and via a nasoduodenal tube (×4) within 10 days. The patient developed abdominal pain and pyrexia after each FMT session. Analyses revealed the transferred donor fecal microbiota had not been retained by the patient, who ultimately underwent colectomy. The severity of the UC and/or timing of FMT may have partly accounted for the poor outcome.
Systematic review with meta-analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis. [2022]Faecal microbiota transplantation (FMT) is emerging as a novel therapy for ulcerative colitis (UC). Interpretation of efficacy of FMT for UC is complicated by differences among studies in blinding, FMT administration procedures, intensity of therapy and donor stool processing methods.
Fecal microbiota transplantation treatment for refractory ulcerative colitis with allergy to 5-aminosalicylic acid: A case report. [2021]Fecal microbiota transplantation (FMT) is currently being explored as a potential therapy for ulcerative colitis (UC). Here, we report the first case of a UC patient with allergy to 5-aminosalicylic acid (5-ASA) who underwent FMT and achieved clinical remission.
Effect of Fecal Microbiota Transplantation on 8-Week Remission in Patients With Ulcerative Colitis: A Randomized Clinical Trial. [2020]High-intensity, aerobically prepared fecal microbiota transplantation (FMT) has demonstrated efficacy in treating active ulcerative colitis (UC). FMT protocols involving anaerobic stool processing methods may enhance microbial viability and allow efficacy with a lower treatment intensity.
[Patient perception and approval of fecal microbiota transplantation (FMT) as an alternative treatment option for ulcerative colitis]. [2022]Fecal microbiota transplantation (FMT) represents a treatment option for recurring Clostridium difficile-associated colitis. However, there is also evidence that FMT can be effective in treating ulcerative colitis. This study examined the approval and willingness of affected patients who underwent FMT.
Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. [2022]Fecal microbiota transplantation (FMT) is a promising new strategy in the treatment of Inflammatory Bowel Disease, but long-term delivery systems are lacking. This randomized study was designed as a safety and feasibility study of long-term FMT in subjects with mild to moderate UC using frozen, encapsulated oral FMT (cFMT).
Lyophilised oral faecal microbiota transplantation for ulcerative colitis (LOTUS): a randomised, double-blind, placebo-controlled trial. [2022]Faecal microbiota transplantation (FMT) delivered via colonoscopic infusion or enemas have been shown to induce remission in a proportion of patients with active ulcerative colitis. Whether orally administered FMT is effective in ulcerative colitis is unknown. We aimed to assess the efficacy of oral lyophilised FMT for the treatment of active ulcerative colitis.
Microbial determinants of effective donors in faecal microbiota transplantation for UC. [2023]Faecal microbiota transplantation (FMT) has variable efficacy in treating UC. Recently, oral lyophilised FMT was found to induce remission in patients with UC, with one donor having 100% efficacy compared with a second donor (36% efficacy). We characterised differences in the gut microbiota of these two donors with the aim of improving FMT donor selection.