Microbiota Transplant Therapy for Crohn's Disease
Recruiting in Palo Alto (17 mi)
Overseen byByron Vaughn
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Minnesota
Must not be taking: Antibiotics
Disqualifiers: Extensive bowel resection, Gastroparesis, Pregnancy, Active infection, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. The emergence of fecal microbiota transplantation (FMT) for the treatment of recurrent C. difficile infections (rCDI) has opened a frontier of restorative therapies targeting the gut microbiome. This study aims to assess if two forms of encapsulated FMT material (MTP101C and MTP101S) can effectively engraft in the ileum and colon of individuals with CD. This study will also assess how the impact of CD phenotype impacts engraftment. Finally this study will explore symptom and endoscopic changes before and after these two therapies.
Will I have to stop taking my current medications?
The trial requires that any ongoing Crohn's disease therapy, except for steroids, must be at stable doses for 4 weeks before starting the trial and remain stable during the study. Steroid use must be below 20mg by 5 days before starting, and prednisone must be tapered below 20mg after 7 days.
What data supports the effectiveness of the treatment Standardized Microbiota Transplant Therapy for Crohn's Disease?
Research shows that fecal microbiota transplantation (FMT) can help patients with Crohn's disease who do not respond to other treatments, leading to clinical remission and improvement in symptoms. FMT has also been effective in treating other conditions like recurrent Clostridioides difficile infection, suggesting its potential in managing Crohn's disease by restoring healthy gut bacteria balance.
12345Is Microbiota Transplant Therapy safe for humans?
Fecal Microbiota Transplantation (FMT) has been used for various conditions, including Crohn's disease and Clostridium difficile infection, but safety data is still limited. Short-term side effects can occur, and long-term safety is not well understood, so more research is needed to fully assess its safety in humans.
678910How is Microbiota Transplant Therapy different from other treatments for Crohn's Disease?
Microbiota Transplant Therapy, also known as Fecal Microbiota Transplantation (FMT), is unique because it involves transferring healthy bacteria from a donor's stool to a patient's gut to restore a balanced microbiome, which is different from traditional drug treatments that often target inflammation directly.
25111213Eligibility Criteria
This trial is for English-speaking adults aged 18-89 with Crohn's Disease, confirmed by clinical and histologic features. Participants must have a certain level of disease activity (SES-CD ≥ 6, or SES-CD ≥ 4 for isolated ileal disease) and be on stable CD therapies excluding high-dose steroids.Inclusion Criteria
* Able and willing to provide informed consent.
* 18-89 years of age.
* English speaking.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive encapsulated FMT material (MTP101C or MTP101S) to assess engraftment in the ileum and colon
8 weeks
Regular visits for monitoring and sample collection
Follow-up
Participants are monitored for safety, tolerability, and changes in clinical symptoms and endoscopic inflammation
4 months
Visits at 2 months and 6 months
Participant Groups
The study tests two encapsulated fecal microbiota transplant materials, MTP101C and MTP101S, to see if they can settle in the gut of Crohn's patients and improve symptoms. It also looks at how different types of Crohn's affect this process.
2Treatment groups
Experimental Treatment
Group I: CD patients randomized to MTP-101SExperimental Treatment1 Intervention
Group II: CD patients randomized to MTP-101CExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
Fecal microbiota transplantation for refractory Crohn's disease. [2022]Approximately one-third of patients with Crohn's disease do not respond to conventional treatments, and some experience significant adverse effects, such as serious infections and lymphoma, and many patients require surgery due to complications. Increasing evidence suggests that specific changes in the composition of gut microbiota, termed as dysbiosis, are a common feature in patients with inflammatory bowel disease (IBD). Dysbiosis can lead to activation of the mucosal immune system, resulting in chronic inflammation and the development of mucosal lesions. Recently, fecal microbiota transplantation, aimed at modifying the composition of gut microbiota to overcome dysbiosis, has become a potential alternative therapeutic option for IBD. Herein, we present a patient with Crohn's colitis in whom biologic therapy failed previously, but clinical remission and endoscopic improvement was achieved after a single fecal microbiota transplantation infusion.
Fecal microbiota transplantation therapy in Crohn's disease: Systematic review. [2022]The gastrointestinal microbiota is the key antigenic drive in the inflammatory bowel diseases. Randomized controlled trials (RCTs) in ulcerative colitis have established fecal microbiota transplantation (FMT) as an effective therapy. We have conducted a systematic review to evaluate the efficacy of FMT in Crohn's disease.
Higher alpha diversity and Lactobacillus blooms are associated with better engraftment after Fecal Microbiota Transplant in Inflammatory Bowel Disease. [2023]Label="Background" NlmCategory="UNASSIGNED">Fecal Microbiota Transplant (FMT) has proven effective in treating recurrent Clostridioides difficile infection (rCDI) and has shown some success in treating inflammatory bowel diseases (IBD). There is emerging evidence that host engraftment of donor taxa is a tenet of successful FMT. However, there is little known regarding predictors of engraftment. We undertook a double-blind, randomized, placebo-controlled pilot study to characterize the response to FMT in children and young adults with mild to moderate active Crohn's disease (CD) and ulcerative colitis (UC).
Increased Intestinal Microbial Diversity Following Fecal Microbiota Transplant for Active Crohn's Disease. [2023]The microbiota in the lumen of patients with Crohn's disease (CD) is characterized by reduced diversity, particularly Firmicutes and Bacteroidetes. It is unknown whether the introduction of the intestinal microbiota from healthy individuals could correct this dysbiosis and reverse mucosal inflammation. We investigated the response to fecal microbial transplantation (FMT) from healthy individuals to subjects with active CD.
Fecal microbiota transplantation to maintain remission in Crohn's disease: a pilot randomized controlled study. [2021]The role of the gut microbiota in Crohn's disease (CD) is established and fecal microbiota transplantation (FMT) is an attractive therapeutic strategy. No randomized controlled clinical trial results are available. We performed a randomized, single-blind, sham-controlled pilot trial of FMT in adults with colonic or ileo-colonic CD.
The Safety of Fecal Microbiota Transplantation for Crohn's Disease: Findings from A Long-Term Study. [2019]Fecal microbiota transplantation (FMT) has been used as a potential treatment option for Crohn's disease (CD). However, there is still lack of safety and efficacy evidence based on large samples of CD undergoing FMT. This study aimed to evaluate the risk factors of adverse event (AE) in the long term and the efficacy of FMT in the short term for patients with CD.
Role of fecal microbiota transplantation in inflammatory bowel disease. [2018]There is increasing evidence of the key role played by altered intestinal microbiota in the pathogenesis of inflammatory bowel disease (IBD). Management strategies involving immune modulation are effective and widely used, but treatment failures and side effects occur. Fecal microbiota transplantation (FMT) provides a novel, perhaps complementary, strategy to restore the normal gut microbiota in patients with IBD. This review summarizes the available efficacy and safety data on the use of FMT in patients with IBD. Several aspects remain to be clarified about the clinical predictors of the response to FMT, its most appropriate route of administration, and the most appropriate quantity and quality of microbiota to be transplanted. Further studies focusing on long-term outcomes and safety are also warranted.
[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. [2020]Fecal microbiota transplantation (FMT), also known as fecal bacteriotherapy or fecal infusion, consists of injection of a liquid filtrate of feces from a healthy donor into the gastrointestinal tract of a recipient individual. FMT has been proposed as a therapeutic approach for functional diseases of the gastrointestinal tract by reestablishment of a wide diversity of intestinal flora. Clostridium difficile infection (CDI) treatment guideline from American Gastroenterology Association (AGA) recommends that FMT can be used as the treatment protocols of relapse CDI. Numerous case reports, retrospective case series, and randomized controlled trials have shown the benefit of FMT in patients with functional bowel disorders, including inflammatory bowel disease, irritable bowel syndrome and constipation, etc. Evidence regarding the safety of FMT is relatively limited because the very rapid adoption of FMT as a therapeutic modality for CDI occurred before the performance of large, long prospective trials that are typically conducted to assess the safety of new interventions. Potential adverse events can be categorized as short-term and long-term, and short-term events can further be divided into those related to the method of FMT delivery (colonoscopy, sedation) and those related to the FMT itself. Due to the recent emergence of FMT, little data exist regarding long-term events and many safety concerns are speculative. Capsulized FMT therapy solves the clinical problems associated with the use of fresh FMT suspensions for long-term maintenance i.e. repeat transplantation and invasive procedures, which is of great significance to optimize the traditional FMT clinical strategy. Future work will focus on establishing best practices and more robust safety data than exist currently, as well as refining FMT beyond current "whole-stool" transplants to increase safety and tolerability. Encapsulated formulations, full-spectrum stool-based products, and defined microbial consortia are all in the immediate future. Although challenges exist, regulatory agencies have been willing to work with stakeholders and will continue to evolve and adapt policy as therapeutics based on human gut microbiota research emerge.
The Current Landscape and Lessons from Fecal Microbiota Transplantation for Inflammatory Bowel Disease: Past, Present, and Future. [2022]Fecal microbiota transplantation (FMT) has changed the standard of care for Clostridium difficile infection. However, there is limited data focusing on efficacy and safety profile of FMT in patients with C. difficile infection with underlying inflammatory bowel disease (IBD), including the risk of IBD flare. Recently, there is also emerging evidence supporting the role of FMT to treat IBD including promising randomized trials in ulcerative colitis. However, with heterogeneity across these studies, the clinical application of this emerging therapy has yet to be fully elucidated. Here, we aim to review the current landscape of this rapidly developing field, mapping the efficacy and safety of FMT (1) to treat C. difficile infection in patients with IBD, (2) to treat underlying IBD, and (3) outline ongoing clinical trials and the future of the microbiome space.
Fecal Microbiota Transplant via Endoscopic Delivering Through Small Intestine and Colon: No Difference for Crohn's Disease. [2020]Crohn's disease (CD) is a chronic inflammatory bowel disorder associated with intestinal dysbiosis. This study aimed to determine the efficacy and safety of different methods of fecal microbiota transplantation (FMT), a potential therapy for CD.
Fecal microbiota transplantation for severe enterocolonic fistulizing Crohn's disease. [2022]The concept of fecal microbiota transplantation (FMT) has been used in traditional Chinese medicine at least since the 4(th) century. Evidence from recent human studies strongly supports the link between intestinal bacteria and inflammatory bowel disease. We proposed that standardized FMT might be a promising rescue therapy for refractory inflammatory bowel disease. However, there were no reports of FMT used in patients with severe Crohn's disease (CD). Here, we report the successful treatment of standardized FMT as a rescue therapy for a case of refractory CD complicated with fistula, residual Barium sulfate and formation of intraperitoneal large inflammatory mass. As far as we know, this is the first case of severe CD treated using FMT through mid-gut.
Fecal microbiota transplantation in the treatment of Crohn disease. [2021]Fecal microbiota transplantation (FMT) is an alternative treatment option with minimal risk for patients with Crohn disease. This article explains FMT and how it effectively targets the gut microbiota changes associated with the pathogenesis of Crohn disease.
Fecal microbial transplant effect on clinical outcomes and fecal microbiome in active Crohn's disease. [2022]Crohn's disease (CD) is a chronic idiopathic inflammatory intestinal disorder associated with fecal dysbiosis. Fecal microbial transplant (FMT) is a potential therapeutic option for individuals with CD based on the hypothesis that changing the fecal dysbiosis could promote less intestinal inflammation.