Depression Clinical Trial
Official title:
A Clinical Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder
The primary goals of this proof of concept clinical trial are to determine the effectiveness, safety and tolerability of oral FMT in adults with Treatment Resistant Depression (TRD).
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 4, 2024 |
Est. primary completion date | March 4, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Between 18-65 years of age: Participants should be at least 18 years old and not older than 65 years at the day of screening 2. Have a primary diagnosis of MDD according to the M.I.N.I. International Neuropsychiatric Interview (MINI)47 3. Medical history suggestive of Treatment Resistant Depression (TRD). (inadequate response to at least 2 approved antidepressants. at least one of which is in the current episode of depression)48 4. Have been on a current treatment with a approved antidepressant at an adequate dose for at least 8 weeks 5. A MADRS score of = 19 at screening and visit 2 Additional Inclusion Criteria: - Participants who will be included in the IBS-D cohort should have a confirmed diagnosis of IBS-D as indicated by the referring gastroenterologist. Exclusion Criteria: - 1. Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5)1 Criteria for the following conditions according to the M.I.N.I: f) Substance Use Disorder within the last 3 months. *(Criteria should include Alcohol and non-alcohol substances except Cannabis) g) Moderate or severe Substance use disorder for Cannabis use the last 3 months h) Active Anorexia Nervosa or Bulimia nervosa i) Schizophrenia or schizoaffective disorder j) Active suicidality 2. Regular intake of non-steroidal anti-inflammatory drugs, antibiotics, or iron supplements for medical purposes in the 3 months prior to study entry 3. Use of prebiotics or probiotics for medical purposes for more than 2 weeks within the last 3 months 4. Clinically diagnosed chronic gastrointestinal diseases (IBD, Crohn's disease, Ulcerative colitis, Celiac disease) 5. Conditions causing immune suppression 6. Not breastfeeding, pregnant or seeking to get pregnant during the course of this study. Be using an acceptable method of birth control (implants, injectable, combined oral contraceptives, IUDs, sexual abstinence or a vasectomized partner) 7. Reported allergy to Vancomycin or Nitazoxanide |
Country | Name | City | State |
---|---|---|---|
Canada | Cumming School of Medicine, University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Cumming school of medicine, The W. Garfield Westin Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To assess the effect of FMT on microbiome profile | Changes will be assessed using next generation sequencing and nuclear magnetic resonance (NMR) spectrometry | from baseline (pre-intervention) to the final visit (week 13) | |
Other | changes in inflammatory markers (Blood) | To study the changes in inflammatory markers (blood CRP) | from baseline (pre-intervention) to the final visit (week 13) | |
Other | changes in inflammatory markers (stool) | To study the changes in inflammatory markers (fecal calprotectin) | from baseline (pre-intervention) to the final visit (week 13) | |
Other | changes in serum cytokines | To study the changes in serum cytokines (IL-6, IL-10, IL-8, IFN? and TNF) | from baseline (pre-intervention) to the final visit (week 13) | |
Other | To examine imaging changes | examine imaging changes via a structural and functional neuroimaging scan associated with FMT | from baseline (pre-intervention) to the final visit (week 13) | |
Primary | Change in the MADRS total score | To evaluate the effectiveness of adjunct oral FMT as compared to placebo with currently accepted approved therapy for depression | from baseline (pre-intervention) to the final visit (week 13) | |
Secondary | Side effects as reported on the Toronto Side Effect Scale (TSES) | The tolerability of FMT will be assessed using the Toronto Side effects Scale (TSES) | from baseline (pre-intervention) to the final visit (week 13) | |
Secondary | GI tolerability of patients with Irritable Bowel Syndrome (IBS) | GI tolerability will be assessed using the IBS Symptom Severity Scale (IBS SSS) and IBS specific Quality of Life (IBS-QoL) questionnaire | from baseline (pre-intervention) to the final visit (week 13) |
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