Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Bipolar Disorder

Overseen By Teresa Bianco, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Valerie Taylor

Must be taking: First line treatments

Must not be taking: NSAIDs, Iron supplements, Antibiotics

Disqualifiers: Substance abuse, Schizophrenia, Psychotic symptoms, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

35 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether transferring healthy gut bacteria to adults with bipolar disorder depression can improve their mental health. The idea is that healthier gut bacteria can help balance the gut microbiome and reduce symptoms of depression and anxiety. The study is the first of its kind to evaluate the safety and effectiveness of this microbial therapy for major depressive disorder.

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 the treatment generally safe for humans?

The treatment, involving recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF), appears to be generally safe with minimal toxicity and is well-tolerated in both adults and children undergoing bone marrow transplantation. However, there is limited long-term safety data, and lifelong follow-up is recommended for donors. ^{1 2 3 4 5}

How does autologous stem cell transplantation differ from other treatments for acute myeloid leukemia?

Autologous stem cell transplantation is unique because it uses the patient's own stem cells to help recover from high-dose chemotherapy, reducing the risk of complications like graft-versus-host disease that can occur with donor cells. This approach is particularly beneficial for patients who are not eligible for donor transplants and can lead to long-term survival, especially in those with standard risk acute myeloid leukemia. ^{6 7 8 9 10}

Research Team

Valerie Taylor, MD, PhD

Principal Investigator

Women's College Hospital

Eligibility Criteria

Inclusion Criteria

Have a diagnosis of bipolar disorder (BD) (type I or II) according to the Mini International Neuropsychiatric Interview (MINI)

Have been on a stable first line treatment for BD depression at an adequate dose for at least 8 weeks prior to study entry

Outpatient status

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fecal Microbiota Transplantation (FMT) from either their own feces or a healthy donor, combined with approved therapy for bipolar depression

24 weeks

Every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of depression, anxiety, and global function

4 weeks

Treatment Details

Interventions

• Allogenic FMT
• Autologous FMT

Participant Groups

Group I: Allogenic FMT Active Control 1 Intervention

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.

Group II: Autologous FMT Placebo Group 1 Intervention

Participants Randomized to this arm will receive FMT (Fecal Microbiota Transplantation) by re-infusion of their own feces donated earlier in the study.

Who Is Running the Clinical Trial?

Valerie Taylor

Lead Sponsor

Trials

3

Recruited

240+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

References

1. England pubmed.ncbi.nlm.nih.gov

The current status of autologous blood transfusion in Japan--the importance of pre-deposit autologous blood donation program and the needs to achieve patient blood management. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Administration of recombinant human granulocyte-colony-stimulating factor does not induce long-lasting detectable epigenetic alterations in healthy donors. [2014]

3. England pubmed.ncbi.nlm.nih.gov

The use of recombinant human granulocyte macrophage colony-stimulating factor in autologous and allogeneic bone marrow transplantation. [2019]

4. Italy pubmed.ncbi.nlm.nih.gov

Recombinant human granulocyte-macrophage colony-stimulating factor accelerates engraftment kinetics after allogeneic bone marrow transplantation for childhood acute lymphoblastic leukemia. [2011]

5. England pubmed.ncbi.nlm.nih.gov

Regeneration, health status and quality of life after rhG-CSF-stimulated stem cell collection in healthy donors: a cross-sectional study. [2011]

6. Portugal pubmed.ncbi.nlm.nih.gov

Autologous stem cell transplantation in acute myeloid leukemia. Factors influencing outcome. A 13 year single institution experience. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Autologous bone marrow transplantation for hematologic cancer. [2005]

8. United States pubmed.ncbi.nlm.nih.gov

Autologous bone marrow transplantation in hematologic malignancies. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Indications, technique and risks in bone marrow transplantation in adulthood]. [2008]

10. United States pubmed.ncbi.nlm.nih.gov

Autologous Graft-versus-Tumor Effect: Reality or Fiction? [2020]