Last updated: November 27, 2023
Sponsor: University of Calgary
Overall Status: Active - Recruiting
Phase
2/3
Condition
Depression
Treatment
Placebo Capsules
FMT oral Capsules
Clinical Study ID
NCT04805879
REB#19-0016
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Between 18-65 years of age: Participants should be at least 18 years old and not older than 65 years at the day ofscreening
- Have a primary diagnosis of MDD according to the M.I.N.I. InternationalNeuropsychiatric Interview (MINI)47
- Medical history suggestive of Treatment Resistant Depression (TRD). (inadequateresponse to at least 2 approved antidepressants. at least one of which is in thecurrent episode of depression)48
- Have been on a current treatment with a approved antidepressant at an adequate dosefor at least 8 weeks
- 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 diagnosisof IBS-D as indicated by the referring gastroenterologist.
Exclusion
Exclusion Criteria:
- Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5)1Criteria for the following conditions according to the M.I.N.I: f) Substance UseDisorder within the last 3 months. *(Criteria should include Alcohol and non-alcoholsubstances except Cannabis) g) Moderate or severe Substance use disorder for Cannabisuse the last 3 months h) Active Anorexia Nervosa or Bulimia nervosa i) Schizophreniaor schizoaffective disorder j) Active suicidality 2. Regular intake of non-steroidalanti-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 purposesfor more than 2 weeks within the last 3 months 4. Clinically diagnosed chronicgastrointestinal diseases (IBD, Crohn's disease, Ulcerative colitis, Celiac disease)
- Conditions causing immune suppression 6. Not breastfeeding, pregnant or seeking toget pregnant during the course of this study. Be using an acceptable method of birthcontrol (implants, injectable, combined oral contraceptives, IUDs, sexual abstinenceor a vasectomized partner) 7. Reported allergy to Vancomycin or Nitazoxanide
Study Design
Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo Capsules
Phase: 2/3
Study Start date:
March 04, 2021
Estimated Completion Date:
December 04, 2024
Study Description
Connect with a study center
Cumming School of Medicine, University of Calgary
Calgary, Alberta T2N 4 Z6
CanadaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.