Last updated on November 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bipolar Disorder
  • Age: Between 18 - 65 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Between 18-65 years of age
  2. Outpatient status
  3. Have a diagnosis of bipolar disorder (BD) (type I or II) according to the Mini International Neuropsychiatric Interview (MINI)
  4. Have been on a stable first line treatment for BD depression at an adequate dose for at least 8 weeks prior to study entry
  5. Suffer from a current depressive episode (Montgomery-sberg Depression Rating Scale (MADRS) score at screening and baseline of 12)

Exclusion Criteria:

  1. DSM-IV criteria for substance abuse within the last 6 months or lifetime dependency
  2. Active eating disorders
  3. Schizophrenia or schizoaffective disorder
  4. Current psychotic symptoms
  5. A Young Mania Rating Scale (YMRS) score of 12 at screening
  6. Active suicidality
  7. Regular intake of non-steroidal anti-inflammatory drugs or iron supplements in the 3 months prior to study entry
  8. Use of prebiotics or probiotics for medical purposes, use of antibiotics or any experimental drug in the 3 months prior to study entry
  9. Chronic gastrointestinal diseases
  10. Conditions causing immunosuppression
  11. A significant bleeding disorder
  12. Any contraindication to colonoscopy
  13. Pregnancy or breastfeeding

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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