Fecal Microbiota Transplantation for Bipolar Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment option for individuals with bipolar disorder experiencing depression. It tests whether fecal microbiota transplantation (FMT), which transfers gut bacteria from a healthy person to someone with bipolar disorder, can improve depression symptoms. The trial includes two groups: one receiving allogenic FMT (from a healthy donor) and another receiving autologous FMT (their own pre-donated gut bacteria). This trial suits those diagnosed with bipolar disorder, currently depressed despite stable treatment, and without substance abuse issues in the last six months. As a Phase 2 and Phase 3 trial, this research evaluates the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it requires that you have been on a stable treatment for bipolar depression for at least 8 weeks before joining. This suggests you should continue your current medication.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that fecal microbiota transplantation (FMT) is generally safe when donors undergo careful screening. In previous studies, FMT has been used for various gut issues and has demonstrated a good safety record. Most risks associated with FMT are short-term and relate to the administration method.
For allogenic FMT, where gut bacteria come from a healthy donor, thorough checks ensure the donor is healthy and free from certain diseases. This process reduces the risk of transmitting unwanted bacteria or viruses.
Since this trial is in later stages, there is already some confidence in the safety of FMT. Although using FMT to treat bipolar disorder is new, its past use in other conditions suggests it should be well-tolerated.12345Why are researchers excited about this trial's treatments?
Researchers are excited about fecal microbiota transplantation (FMT) for bipolar disorder because it offers a novel approach by targeting the gut-brain axis. Unlike standard treatments such as mood stabilizers and antipsychotics, which primarily focus on brain chemistry, FMT aims to alter gut microbiota to potentially influence mood regulation. The allogenic FMT, in particular, involves transplanting gut bacteria from a healthy donor, which could introduce beneficial microbes absent in individuals with bipolar disorder. This method opens up a new avenue for understanding and treating mental health conditions through the gut, offering hope for more personalized and potentially effective interventions.
What evidence suggests that FMT could be an effective treatment for bipolar depression?
Research shows that fecal microbiota transplantation (FMT) can treat certain conditions by introducing healthy gut bacteria to patients. This trial will compare two types of FMT: Autologous FMT, where participants receive their own feces, and Allogenic FMT, where participants receive feces from a healthy, screened donor. Although no clinical trials have specifically tested FMT for bipolar disorder, it has effectively treated recurrent Clostridioides difficile infections by restoring a healthy gut balance. The gut-brain connection, known as the microbiome-gut-brain axis, provides a biological reason to consider FMT for bipolar disorder. This connection suggests that improving gut health might also improve mental health symptoms. Early studies in other areas indicate that changing gut bacteria can affect inflammation, which links to mood disorders like bipolar disorder.56789
Who Is on the Research Team?
Valerie Taylor, MD, PhD
Principal Investigator
Women's College Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Fecal Microbiota Transplantation (FMT) from either their own feces or a healthy donor, combined with approved therapy for bipolar depression
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of depression, anxiety, and global function
What Are the Treatments Tested in This Trial?
Interventions
- Allogenic FMT
- Autologous FMT
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Participants Randomized to this arm will receive FMT (Fecal Microbiota Transplantation) from a healthy, screened individual with no personal or family history of an Axis 1 disorder.
Participants Randomized to this arm will receive FMT (Fecal Microbiota Transplantation) by re-infusion of their own feces donated earlier in the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Valerie Taylor
Lead Sponsor
University Health Network, Toronto
Collaborator
Citations
Fecal microbiota transplantation for refractory chronic graft ...
Conclusions: The results of the present study suggest that FMT is feasible and deserves further investigation for use in patients with ...
Long-term health outcomes in adolescents with obesity ...
Faecal microbiota transplantation (FMT) has been explored as a potential treatment for obesity, but its long-term effects on metabolic ...
Clinical effectiveness of fecal microbial transplantation for ...
Fecal microbial transplantation (FMT) has demonstrated great promise in reducing insulin resistance and abdominal obesity in individuals with metabolic ...
Faecal Microbiota Transplantation After Allogeneic Stem ...
The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell ...
Effect of fecal microbiota transplantation on gut ...
Fecal microbiota transplantation (FMT) is a holistic therapeutic approach recommended for the treatment of recurrent/refractory Clostridioides ...
Safety and efficacy of fecal microbiota transplantation (FMT ...
This comprehensive literature review offers increased confidence in the safety and effectiveness of FMT for several diseases affecting the intestines and other ...
Regulation, risk and safety of Faecal Microbiota Transplant
FMT is generally considered safe, especially if rigorous donor screening and testing is conducted. Most short-term risks are associated with the delivery ...
Fecal microbiota transplantation for refractory chronic graft ...
Fecal microbiota transplantation (FMT) was first demonstrated to be safe and effective in patients with systemic lupus erythematosus (SLE) [24].
Review Fecal microbiota transplantation in clinical practice
The data included here mainly include patients exhibiting gastrointestinal symptoms [2]. The effectiveness rate of FMT treatment in this context was 48.3%, ...
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