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Major Depressive DisorderPhase 2/3NCT05174273

Neurocognitive Effects of FMT in MDD Patients With and Without IBS

A Phase 2/3 study testing Fecal Microbiota Transplantation in people with Major Depressive Disorder and Irritable Bowel Syndrome, run by Valerie Taylor at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Fecal Microbiota Transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
1 siteCanada
Study dates
6 Apr 2022to 21 Oct 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Calgary, TRW building

    Calgary, Alberta, T2N 4Z6

Other trials in Canada

About this study

Official title: Understanding the Neurocognitive Effects of Fecal Microbiota Transplantation in Major Depressive Disorder Patients With and Without Irritable Bowel Syndrome

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. Additionally, trial feasibility will be monitored via recruitment rate, study visits adherence and participant retention to inform future trial scalability."

Being tested
Fecal Microbiota Transplantation
Keywords
Major depression, IBS, Fecal microbiota Transplantation, Gut, Microbiome, fMRI
Medical subject headings
Depressive Disorder, Major, Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal Microbiota TransplantationBiological

    Also called FMT

    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.

Study groups in NCT05174273
Study groupRoleWhat they receive
Participants with a confirmed diagnosis of MDD receiving TAUNo interventionEligible 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.
Participants with a confirmed diagnosis MDD who will receive FMT + TAUActive comparatorEligible 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.
Receives: Biological: Fecal Microbiota Transplantation
Participants with a confirmed diagnosis of MDD + IBS assigned to continue with TAUNo interventionNot described
Participants with a confirmed diagnosis of MDD + IBS assigned to receive FMT + TAUActive comparatorNot described
Receives: Biological: Fecal Microbiota Transplantation
Participants with a confirmed diagnosis IBS only receiving TAUNo interventionNot described
Healthy ControlsNo interventionData 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to week 13

  2. 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.

    Measured: Baseline to week 13

Secondary outcomes (3)

  1. 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.

    Measured: Baseline to Week 13

  2. 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.

    Measured: Baseline to Week 13

  3. nuclear magnetic resonance (NMR) spectrometry

    To assess the effect of FMT on microbiome profile (community structure and functional metagenome).

    Measured: Baseline to Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2021
  2. Study start6 Apr 2022
  3. Primary completion21 Oct 2024
  4. Study completion21 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05174273
Sponsor's protocol ID
IMA-FMT-MDD/IBS-2020
Status last verified
Mar 2026
First submitted
13 Dec 2021
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Association, A.P., Diagnostic and Statistical Manual of Mental Disorders. 5th Edition ed. 2013, Arlington, VA: American Psychiatric Publishing.

  • Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet. 2007 Sep 8;370(9590):851-8. doi: 10.1016/S0140-6736(07)61415-9.

    PubMed 17826170

  • Parikh SV, Segal ZV, Grigoriadis S, Ravindran AV, Kennedy SH, Lam RW, Patten SB; Canadian Network for Mood and Anxiety Treatments (CANMAT). Canadian Network for Mood and Anxiety Treatments (CANMAT) clinical guidelines for the management of major depressive disorder in adults. II. Psychotherapy alone or in combination with antidepressant medication. J Affect Disord. 2009 Oct;117 Suppl 1:S15-25. doi: 10.1016/j.jad.2009.06.042. Epub 2009 Aug 13.

    PubMed 19682749

  • Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.

    PubMed 17074942

  • Colom F, Vieta E, Martinez-Aran A, Reinares M, Benabarre A, Gasto C. Clinical factors associated with treatment noncompliance in euthymic bipolar patients. J Clin Psychiatry. 2000 Aug;61(8):549-55. doi: 10.4088/jcp.v61n0802.

    PubMed 10982196

  • Taylor VH, McIntyre RS, Remington G, Levitan RD, Stonehocker B, Sharma AM. Beyond pharmacotherapy: understanding the links between obesity and chronic mental illness. Can J Psychiatry. 2012 Jan;57(1):5-12. doi: 10.1177/070674371205700103.

    PubMed 22296962

  • Whitehead WE, Crowell MD. Psychologic considerations in the irritable bowel syndrome. Gastroenterol Clin North Am. 1991 Jun;20(2):249-67.

    PubMed 2066151

  • Neufeld KM, Kang N, Bienenstock J, Foster JA. Reduced anxiety-like behavior and central neurochemical change in germ-free mice. Neurogastroenterol Motil. 2011 Mar;23(3):255-64, e119. doi: 10.1111/j.1365-2982.2010.01620.x. Epub 2010 Nov 5.

    PubMed 21054680

  • Lyte M, Li W, Opitz N, Gaykema RP, Goehler LE. Induction of anxiety-like behavior in mice during the initial stages of infection with the agent of murine colonic hyperplasia Citrobacter rodentium. Physiol Behav. 2006 Oct 30;89(3):350-7. doi: 10.1016/j.physbeh.2006.06.019. Epub 2006 Aug 2.

    PubMed 16887154

  • Bravo JA, Forsythe P, Chew MV, Escaravage E, Savignac HM, Dinan TG, Bienenstock J, Cryan JF. Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve. Proc Natl Acad Sci U S A. 2011 Sep 20;108(38):16050-5. doi: 10.1073/pnas.1102999108. Epub 2011 Aug 29.

    PubMed 21876150

  • Lyte, M., Microbial endocrinology and nutrition: A perspective on new mechanisms by which diet can influence gut-to-brain communication. PharmaNutrition, 2013. 1(1): p. 35-39. https://doi.org/10.1016/j.phanu.2012.11.002

  • De Palma G, Lynch MD, Lu J, Dang VT, Deng Y, Jury J, Umeh G, Miranda PM, Pigrau Pastor M, Sidani S, Pinto-Sanchez MI, Philip V, McLean PG, Hagelsieb MG, Surette MG, Bergonzelli GE, Verdu EF, Britz-McKibbin P, Neufeld JD, Collins SM, Bercik P. Transplantation of fecal microbiota from patients with irritable bowel syndrome alters gut function and behavior in recipient mice. Sci Transl Med. 2017 Mar 1;9(379):eaaf6397. doi: 10.1126/scitranslmed.aaf6397.

    PubMed 28251905

  • Kelly JR, Borre Y, O' Brien C, Patterson E, El Aidy S, Deane J, Kennedy PJ, Beers S, Scott K, Moloney G, Hoban AE, Scott L, Fitzgerald P, Ross P, Stanton C, Clarke G, Cryan JF, Dinan TG. Transferring the blues: Depression-associated gut microbiota induces neurobehavioural changes in the rat. J Psychiatr Res. 2016 Nov;82:109-18. doi: 10.1016/j.jpsychires.2016.07.019. Epub 2016 Jul 25.

    PubMed 27491067

  • Kurokawa S, Kishimoto T, Mizuno S, Masaoka T, Naganuma M, Liang KC, Kitazawa M, Nakashima M, Shindo C, Suda W, Hattori M, Kanai T, Mimura M. The effect of fecal microbiota transplantation on psychiatric symptoms among patients with irritable bowel syndrome, functional diarrhea and functional constipation: An open-label observational study. J Affect Disord. 2018 Aug 1;235:506-512. doi: 10.1016/j.jad.2018.04.038. Epub 2018 Apr 12.

    PubMed 29684865

  • Duan R, Zhu S, Wang B, Duan L. Alterations of Gut Microbiota in Patients With Irritable Bowel Syndrome Based on 16S rRNA-Targeted Sequencing: A Systematic Review. Clin Transl Gastroenterol. 2019 Feb;10(2):e00012. doi: 10.14309/ctg.0000000000000012.

    PubMed 30829919

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Fecal Microbiota Transplantation in people with Major Depressive Disorder and Irritable Bowel Syndrome, run by Valerie Taylor at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: Baseline to week 13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05174273, which also lists 84 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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