Neurocognitive Effects of FMT in MDD Patients With and Without IBS

  • STATUS
    Recruiting
  • End date
    Apr 8, 2024
  • participants needed
    180
  • sponsor
    Valerie Taylor
Updated on 8 June 2022
constipation
diarrhea
microbiota
antidepressants
fecal microbiota transplantation

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."

Details
Condition Major Depressive Disorder, Irritable Bowel Syndrome
Treatment Fecal Microbiota Transplantation
Clinical Study IdentifierNCT05174273
SponsorValerie Taylor
Last Modified on8 June 2022

Eligibility

Yes No Not Sure

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)
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