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| Name | Class |
|---|---|
| The W. Garfield Westin Foundation | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT capsules | Active Comparator | Each dose of FMT capsules consists of 20 capsules. The 20 over encapsulated capsules are derived from 100 grams of stool and each containing 0.67 ml of pelleted intestinal microbes. PArticipants will recieve a loading dose of 60 capsules over 3 consecutive days followed by a booster dose of 20 caspules 1 month after and a second similar booster dose a month after that |
|
| Placebo oral Capsules | Placebo Comparator | Placebo casules are inactive capsules that look and weigh the same as the Active FMT caspules. Participants will follow the same schedule as the Active arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMT oral Capsules | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| GI tolerability of patients with Irritable Bowel Syndrome (IBS) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| changes in inflammatory markers (Blood) |
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 of screening
Have a primary diagnosis of MDD according to the M.I.N.I. International Neuropsychiatric Interview (MINI)47
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
Have been on a current treatment with a approved antidepressant at an adequate dose for 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 diagnosis of IBS-D as indicated by the referring gastroenterologist.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asem Bala, BDS, MSc | Contact | 403-210-7282 | asem.bala@ucalgary.ca | |
| Vivek Kumar, MBBS | Contact | 403-210-8650 | vivek.kumar@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Valerie Taylor, MD, PhD | Cumming School of Medicine, University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cumming School of Medicine, University of Calgary | Recruiting | Calgary | Alberta | T2N 4 Z6 | Canada |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Placebo Capsules | Biological | Placebo Capsules that will look and weigh the same as the FMT oral capsules. |
|
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) |
To study the changes in inflammatory markers (blood CRP) |
| from baseline (pre-intervention) to the final visit (week 13) |
| changes in inflammatory markers (stool) | To study the changes in inflammatory markers (fecal calprotectin) | from baseline (pre-intervention) to the final visit (week 13) |
| changes in serum cytokines | To study the changes in serum cytokines (IL-6, IL-10, IL-8, IFNγ and TNF) | from baseline (pre-intervention) to the final visit (week 13) |
| 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) |
| D001523 |
| Mental Disorders |