Status:
TERMINATED
Fecal Microbiota Transplantation in Depression
Lead Sponsor:
Psychiatric Hospital of the University of Basel
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The prevalence of psychiatric disorders such as major depression disorder (MDD) is increasing rapidly. Despite advancements in the development of therapeutics, current treatment options have not reach...
Eligibility Criteria
Inclusion
- Age ≥ 18, body mass index 20-30 kg/m²
- Able to provide signed and dated informed consent
- Patients with moderate to severe depression (as expressed by a Hamilton Depression Rating Scale (HAMD-17) \> 17)
- Treatment as usual for depression
- In- and outpatients at the UPK Basel
Exclusion
- Patients with mild MDD (HAMD-17 \< 17)
- Comorbid psychiatric disturbances such as substance abuse disorder, bipolar disorder, schizophrenia, eating disorders.
- Current medical conditions such as acute infectious disease,
- Dietary restrictions (vegetarian, vegan, gluten-free, PEG/TPN feeding, and any kind of deviation from the UPK standard catering)
- Recent use of medications besides their anti-depressant medication (within 3 months, mainly antibiotics or probiotic consumption within last six weeks).
- Pregnancy (tested before both MRI scans using the AlereTM TestPack +Plus hCG Urine Test), breast-feeding
- Body Mass Index (BMI) \> 30
- Current or recent use of antibiotics (within 3 months before inclusion)
- Anticipated antibiotic use in upcoming 4 weeks
- Inability to read and understand the participant's information and informed consent form
- Inability (e.g. dysphagia) to or unwilling to swallow capsules
- Active vomiting
- Known or suspected toxic megacolon and/or known small bowel ileus
- Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrolment. This does not include appendectomy or cholecystectomy.
- History of total colectomy or bariatric surgery.
- Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy. Patients on maintenance chemotherapy may be enrolled only after consultation with a medical monitor.
- Life expectancy \< 6 months
- Patients with a history of severe anaphylactic or anaphylactoid food allergy
- Solid organ transplant recipients ≤ 90 days post-transplant or on active treatment for rejection
- Neuropenia (≤500 neutrophils/mL) or other severe immunosuppression. Anti-TNF will be permitted. Patients on monoclonal antibodies to B and T cells, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine, methotrexate), calcineurin inhbitors (tacrolimus, cyclosporine) and mycophenolate mofetil may be enrolled only after consultation with the medical monitor.
- A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study.
Key Trial Info
Start Date :
October 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03281044
Start Date
October 24 2018
End Date
March 16 2020
Last Update
April 16 2020
Active Locations (1)
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1
University Psychiatric Clinics (UPK)
Basel, Switzerland, 4012