Status:
UNKNOWN
Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Bipolar Disorder
Lead Sponsor:
Valerie Taylor
Collaborating Sponsors:
University Health Network, Toronto
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Every human harbors complex microbial communities (collectively, the human 'microbiome') that cover the skin and the body's mucosal surfaces. There is mounting evidence of an interaction between the i...
Detailed Description
The primary goals of this proof of concept study are to determine the effectiveness, safety and tolerability of FMT in adults with BD depression. Objective 1: To evaluate the effectiveness of the com...
Eligibility Criteria
Inclusion
- Between 18-65 years of age
- Outpatient status
- 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
- Suffer from a current depressive episode (Montgomery-Åsberg Depression Rating Scale (MADRS) score at screening and baseline of ≥ 12)
Exclusion
- DSM-IV criteria for substance abuse within the last 6 months or lifetime dependency
- Active eating disorders
- Schizophrenia or schizoaffective disorder
- Current psychotic symptoms
- A Young Mania Rating Scale (YMRS) score of ≥12 at screening
- Active suicidality
- Regular intake of non-steroidal anti-inflammatory drugs or iron supplements in the 3 months prior to study entry
- Use of prebiotics or probiotics for medical purposes, use of antibiotics or any experimental drug in the 3 months prior to study entry
- Chronic gastrointestinal diseases
- Conditions causing immunosuppression
- A significant bleeding disorder
- Any contraindication to colonoscopy
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03279224
Start Date
January 1 2018
End Date
December 31 2022
Last Update
May 4 2022
Active Locations (1)
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1
Women's college Research Institute
Toronto, Ontario, Canada, M5G1N8