Back to resultsNeurocognitive Effects of FMT in MDD Patients With and Without IBS
Primary Purpose
Major Depressive Disorder, Irritable Bowel Syndrome
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Sponsored by
About this trial
This is an interventional other trial for Major Depressive Disorder focused on measuring Major depression, IBS, Fecal microbiota Transplantation, Gut, Microbiome, fMRI
Eligibility Criteria
Inclusion Criteria:
Between 18-60 years of age:
Participants should be at least 18 years old and not older than 60 years at the day of screening
- Have a primary diagnosis of MDD as assessed/confirmed by the M.I.N.I. International Neuropsychiatric Interview (MINI)
- Have had a well-documented inadequate response to at least 2 approved antidepressants
- A MADRS score of ≥ 19 at screening and visit 2a
- Have a comorbid diagnosis of IBS. IBS patients can include any of the following: diarrhea predominant IBS (IBS-D), constipation predominant IBS (IBS-C), IBS with mixed bowel habits (IBS-M), or unclassified with IBS (IBS-U) as confirmed by the referring doctor using ROME III criteria
- Moderate-to-severe IBS symptoms, as indicated by a score of ≥175 on the IBS Severity Scoring System (IBS-SSS)
Exclusion Criteria:
Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5)[1] Criteria for the following conditions according to the M.I.N.I:
- Substance Use Disorder within the last 3 months. *(Criteria should include Alcohol and non-alcohol substances except Cannabis)
- Moderate or severe substance use disorder for Cannabis use the last 3 months
- Active Anorexia Nervosa or Bulimia nervosa
- Schizophrenia, schizoaffective or bipolar disorder
- Active suicidality
- Regular intake of non-steroidal anti-inflammatory drugs, antibiotics, or iron supplements for medical purposes in the three (3) months prior to study entry
- Use of prebiotics or probiotics for medical purposes for more than two (2) weeks within the last three (3) months
- Conditions causing immunosuppression
- Women who are breastfeeding, pregnant or seeking to get pregnant during the course of this study. Not using an acceptable method of birth control (implants, injectable, combined oral contraceptives, IUDs, sexual abstinence or a vasectomized partner)
Sites / Locations
- University of Calgary, TRW buildingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
No Intervention
Active Comparator
No Intervention
Active Comparator
No Intervention
No Intervention
Arm Label
Participants with a confirmed diagnosis of MDD receiving TAU
Participants with a confirmed diagnosis MDD who will receive FMT + TAU
Participants with a confirmed diagnosis of MDD + IBS assigned to continue with TAU
Participants with a confirmed diagnosis of MDD + IBS assigned to receive FMT + TAU
Participants with a confirmed diagnosis IBS only receiving TAU
Healthy Controls
Arm Description
Eligible and consenting patients will be assigned 1:1 to receive either FMT from a healthy donor or continuing on their usual medication for MDD, i.e., treatment as usual (TAU). This arm will continue to receive their usual anti-depressant.
Eligible and consenting patients will be assigned 1:1 to receive either FMT from a healthy donor or continuing on their usual medication for MDD, i.e., treatment as usual (TAU). This arm will be assigned to receive FMT provided by healthy donors.
Data from healthy comparison (HC) participants will be drawn from another completed research study. Healthy comparison participants who will best match the patient population enrolled in the current trial and who consented to data sharing will be selected.
Outcomes
Primary Outcome Measures
The 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
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.
Secondary Outcome Measures
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.
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.
nuclear magnetic resonance (NMR) spectrometry
To assess the effect of FMT on microbiome profile (community structure and functional metagenome).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05174273
Brief Title
Neurocognitive Effects of FMT in MDD Patients With and Without IBS
Official Title
Understanding the Neurocognitive Effects of Fecal Microbiota Transplantation in Major Depressive Disorder Patients With and Without Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Valerie Taylor
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Irritable Bowel Syndrome
Keywords
Major depression, IBS, Fecal microbiota Transplantation, Gut, Microbiome, fMRI
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This study is a phase 2/3 open-label controlled trial (CT) in which adults with MDD with and without IBS who are being treated with an approved antidepressant medication will be assigned to additionally receive either FMT or to continue with their current treatment in a treatment as usual (TAU) arm. An IBS alone group receiving TAU will be recruited as a clinical control group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants with a confirmed diagnosis of MDD receiving TAU
Arm Type
No Intervention
Arm Description
Eligible and consenting patients will be assigned 1:1 to receive either FMT from a healthy donor or continuing on their usual medication for MDD, i.e., treatment as usual (TAU). This arm will continue to receive their usual anti-depressant.
Arm Title
Participants with a confirmed diagnosis MDD who will receive FMT + TAU
Arm Type
Active Comparator
Arm Description
Eligible and consenting patients will be assigned 1:1 to receive either FMT from a healthy donor or continuing on their usual medication for MDD, i.e., treatment as usual (TAU). This arm will be assigned to receive FMT provided by healthy donors.
Arm Title
Participants with a confirmed diagnosis of MDD + IBS assigned to continue with TAU
Arm Type
No Intervention
Arm Title
Participants with a confirmed diagnosis of MDD + IBS assigned to receive FMT + TAU
Arm Type
Active Comparator
Arm Title
Participants with a confirmed diagnosis IBS only receiving TAU
Arm Type
No Intervention
Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Description
Data from healthy comparison (HC) participants will be drawn from another completed research study. Healthy comparison participants who will best match the patient population enrolled in the current trial and who consented to data sharing will be selected.
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplantation
Other Intervention Name(s)
FMT
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
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
Title
IBS Symptom Severity Scale (IBS-SSS)
Description
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
Secondary Outcome Measure Information:
Title
Toronto Side Effect Scale (TSES)
Description
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
Title
IBS specific Quality of Life (IBS-QoL)
Description
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
Title
nuclear magnetic resonance (NMR) spectrometry
Description
To assess the effect of FMT on microbiome profile (community structure and functional metagenome).
Time Frame
Baseline to Week 13
Other Pre-specified Outcome Measures:
Title
structural and functional neuroimaging
Description
fMRI to examine brain imaging changes in response to FMT
Time Frame
Baseline to week 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 18-60 years of age:
Participants should be at least 18 years old and not older than 60 years at the day of screening
Have a primary diagnosis of MDD as assessed/confirmed by the M.I.N.I. International Neuropsychiatric Interview (MINI)
Have had a well-documented inadequate response to at least 2 approved antidepressants
A MADRS score of ≥ 19 at screening and visit 2a
Have a comorbid diagnosis of IBS. IBS patients can include any of the following: diarrhea predominant IBS (IBS-D), constipation predominant IBS (IBS-C), IBS with mixed bowel habits (IBS-M), or unclassified with IBS (IBS-U) as confirmed by the referring doctor using ROME III criteria
Moderate-to-severe IBS symptoms, as indicated by a score of ≥175 on the IBS Severity Scoring System (IBS-SSS)
Exclusion Criteria:
Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5)[1] Criteria for the following conditions according to the M.I.N.I:
Substance Use Disorder within the last 3 months. *(Criteria should include Alcohol and non-alcohol substances except Cannabis)
Moderate or severe substance use disorder for Cannabis use the last 3 months
Active Anorexia Nervosa or Bulimia nervosa
Schizophrenia, schizoaffective or bipolar disorder
Active suicidality
Regular intake of non-steroidal anti-inflammatory drugs, antibiotics, or iron supplements for medical purposes in the three (3) months prior to study entry
Use of prebiotics or probiotics for medical purposes for more than two (2) weeks within the last three (3) months
Conditions causing immunosuppression
Women who are breastfeeding, pregnant or seeking to get pregnant during the course of this study. Not using an acceptable method of birth control (implants, injectable, combined oral contraceptives, IUDs, sexual abstinence or a vasectomized partner)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefanie Hassel, PhD
Phone
4032106430
Email
shassel@ucalgary.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Asem Bala, MSc
Phone
4032107282
Email
asem.bala@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Taylor, MD, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary, TRW building
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asem Bala, MSc
Email
asem.bala@ucalgary.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Neurocognitive Effects of FMT in MDD Patients With and Without IBS
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