The Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder

Depression Clinical Trial

Official title:

A Clinical Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04805879
• Other study ID #: REB#19-0016
• Status: Recruiting
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

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)