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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
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 that will look and weigh the same as the FMT oral capsules.
Cumming School of Medicine, University of Calgary
Calgary, Alberta, Canada
RECRUITINGChange in the MADRS total score
To evaluate the effectiveness of adjunct oral FMT as compared to placebo with currently accepted approved therapy for depression
Time frame: from baseline (pre-intervention) to the final visit (week 13)
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)
Time frame: from baseline (pre-intervention) to the final visit (week 13)
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
Time frame: from baseline (pre-intervention) to the final visit (week 13)
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