A clinical trial to evaluate the safety and efficacy of Fecal Microbiota Transplantation in a population with Major Depressive Disorder
Summary
In the study we want to find out, whether Fecal Microbiota Transplantation (FMT) can improve depression in patients with Major Depressive Disorder. FMT means that a solution prepared from stool of a healthy person is transferred into the gut of a person with a disease. This is already used for people suffering from severe stomach disorders such as C. difficile colotis. We now want to see if this procedure can also reduce the symptoms of depression. If you decide to participate in the study, you will receive FMT either from a healthy screened donor or placebo pill. The FMT will be delivered by oral capsules. You will have a 50:50 chance of receiving placebo capsules or FMT capsules.
For this research study, we are recruiting participants who are on treatment for Major Depressive Disorder but are still experiencing depressive episodes. This study will take about 13 weeks to complete and will include 18 visits to Foothills Medical Center.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 65
Inclusion criteria:
1. Between 18-65 years of age:
2. Participants should be at least 18 years old and not older than 65 years at the day of screening
3. Have a primary diagnosis of MDD according to the M.I.N.I. International Neuropsychiatric Interview (MINI)
4. 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)
5. Have been on a current treatment with a first line treatment for MDD at an adequate dose for at least 8 weeks
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:
a) Substance Use Disorder within the last 3 months.
b) Moderate or severe Substance use disorder for Cannabis use the last 3 months
c) Active Anorexia Nervosa or Bulimia nervosa
d) Schizophrenia or schizoaffective disorder
e) Currently active suicidality
f) Failure to clinically respond to 4 previous antidepressants
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 immunosuppression
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
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
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Additional information
Contact information
Vivek Kumar at 403-210-8650 or fmtmddstudy@ucalgary.ca
Principal investigator:
Valerie Taylor
Clinical trial:
Yes
REB-ID:
REB19-0016