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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04805879
Other study ID # REB#19-0016
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date March 4, 2021
Est. completion date December 4, 2024

Study information

Verified date November 2023
Source University of Calgary
Contact Asem Bala, BDS, MSc
Phone 403-210-7282
Email asem.bala@ucalgary.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

This study is a phase 2/3, double-blinded, randomized controlled trial (RCT) in which 80 adults with TRD being treated with an approved antidepressant medication will be assigned to either FMT capsules or identically appearing placebo capsules. Participant will be followed for f for 14 weeks post FMT. This extended observation period will allow us to see, whether FMT leads to sustainable improvements in depression and changes in intestinal microbiome


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
FMT oral Capsules
Each dose of FMT capsules consists of 20 capsules. The 20 over encapsulated capsules are derived from 100 grams of stool donated by a healthy indvidual that was screened to have no mental health issues or chronic or contagious doseases. Each capsule will contain 0.67 ml of pelleted intestinal microbes. Therefore it is considered that the 20 capsules are equivalent to 100 grams of stool
Placebo Capsules
Placebo Capsules that will look and weigh the same as the FMT oral capsules.

Locations

Country Name City State
Canada Cumming School of Medicine, University of Calgary Calgary Alberta

Sponsors (3)

Lead Sponsor Collaborator
University of Calgary Cumming school of medicine, The W. Garfield Westin Foundation

Country where clinical trial is conducted

Canada, 

Outcome

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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