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Fecal Microbiota Transplantation for Depression

Phase 2 & 3

Recruiting

Led By Valerie Taylor, MD, PhD

Research Sponsored by Valerie Taylor

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants should be between 18-60 years of age

Have a comorbid diagnosis of IBS including 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

Must not have

Participant has conditions causing immunosuppression

Participant has Schizophrenia, schizoaffective or bipolar disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 13

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a treatment called Fecal Microbiota Transplantation (FMT) is effective, safe, and tolerable for adults with Major Depressive Disorder (MDD) who also have Inflammatory Bowel Syndrome (IBS). The study will also look at whether FMT affects cognitive and neural changes associated with MDD and MDD+IBS.

Who is the study for?

Adults aged 18-60 with Major Depressive Disorder (MDD) and/or Irritable Bowel Syndrome (IBS), who haven't responded well to at least two antidepressants, can join. They must have moderate-to-severe IBS symptoms confirmed by a doctor. People with substance use disorders, eating disorders, schizophrenia-related conditions, active suicidality or those on certain medications like NSAIDs cannot participate.

What is being tested?

The trial is testing if swallowing pills containing fecal matter from healthy donors (Fecal Microbiota Transplantation or FMT) can improve depression and cognitive function in people with MDD alone or combined with IBS compared to their usual treatments.

What are the potential side effects?

While the study aims to determine the safety of oral FMT, potential side effects may include digestive discomfort, changes in bowel habits, abdominal pain, bloating and possible immune reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I have been diagnosed with IBS by my doctor.

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I have tried at least 2 antidepressants without success.

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My depression diagnosis was confirmed by a specialized interview.

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My IBS symptoms are moderate to severe, scoring 175 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that weakens my immune system.

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I have been diagnosed with Schizophrenia, schizoaffective, or bipolar disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 13

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 13

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 13 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

IBS Symptom Severity Scale (IBS-SSS)

The Montgomery-Åsberg Depression Rating Scale (MADRS)

Secondary study objectives

IBS specific Quality of Life (IBS-QoL)

Toronto Side Effect Scale (TSES)

nuclear magnetic resonance (NMR) spectrometry

Other study objectives

structural and functional neuroimaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Active Control

Group I: Participants with a confirmed diagnosis MDD who will receive FMT + TAUActive Control1 Intervention

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.

Group II: Participants with a confirmed diagnosis of MDD + IBS assigned to receive FMT + TAUActive Control1 Intervention

Group III: Healthy ControlsActive Control1 Intervention

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.

Group IV: Participants with a confirmed diagnosis IBS only receiving TAUActive Control1 Intervention

Group V: Participants with a confirmed diagnosis of MDD + IBS assigned to continue with TAUActive Control1 Intervention

Group VI: Participants with a confirmed diagnosis of MDD receiving TAUActive Control1 Intervention

0 / 7Eligibility criteria met