This study is a phase 2/3 open-label controlled trial (CT) in which adults with Major Depressive Disorder (MDD) and adults who have MDD plus comorbid Inflammatory Bowel Syndrome (IBS) will be assigned to either receive oral Fecal Microbiota Transplantation (FMT) or to continue with the treatment they are currently receiving in a Treatment As Usual (TAU) arm. An IBS alone group receiving TAU will be recruited as a clinical control group. The primary goals of this study are to determine effectiveness, safety and tolerability of oral FMT in adults with MDD and in MDD who have comorbid IBS. Additional goals are to characterize patterns and progressions of cognitive and neural correlates associated with MDD and with MDD + IBS and to determine if they improve with FMT. It is known that both, individuals with MDD and those with MDD and IBS show cognitive alterations as well as changes in neural structures, but this study is designed to see if those are changed with treatment response to FMT."
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
180
FMT is a technique in which intestinal microbiota are transferred from a healthy screened donor to a patient, with the goal being to introduce or restore a stable microbial community in the gut.
University of Calgary, TRW building
Calgary, Alberta, Canada
RECRUITINGThe Montgomery-Åsberg Depression Rating Scale (MADRS)
a 10-item questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. This will be used to evaluate the effectiveness of adjunct oral FMT as compared to TAU with currently accepted approved therapy for MDD. The MADRS overall score ranges from 0 to 60. Each item yields a score of 0 to 6 and Higher MADRS score indicates more severe depression
Time frame: Baseline to week 13
IBS Symptom Severity Scale (IBS-SSS)
The IBS-SSS is a 5-item questionnaire that is used to assess the severity and frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. Scores on the IBS-SSS can range from 0 to 500 with higher scores indicating more severe symptoms. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (\>300) IBS.
Time frame: Baseline to week 13
Toronto Side Effect Scale (TSES)
The TSES is a 32-item instrument that is designed to establish incidence, frequency, and severity of CNS, GI, and sexual side effects. For each side effect, frequency and severity are measured on a 5-point scale. intensity is measured by multiplying frequency and severity.
Time frame: Baseline to Week 13
IBS specific Quality of Life (IBS-QoL)
is a self-report 34-item instrument used to assess the impact of IBS and its treatment. used to examine GI tolerability in patients with IBS. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.
Time frame: Baseline to Week 13
nuclear magnetic resonance (NMR) spectrometry
To assess the effect of FMT on microbiome profile (community structure and functional metagenome).
Time frame: Baseline to Week 13
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