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Poop pills for depression? new study tests gut bacteria fix

NCT ID NCT06692361

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a fecal microbiota transplant (FMT) — transferring healthy gut bacteria from a donor — can help adults with major depression who aren't getting better with standard antidepressants. About 214 participants will receive either FMT or a placebo, and researchers will measure changes in depression symptoms and gut health. The goal is to see if this approach offers a new, safe way to ease depression when pills alone fall short.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 214 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (All 8 criterion are met): * Outpatient or inpatient, aged 18 to 65 years (inclusive), regardless of gender; * At the start of the screening phase, participants must meet the Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) diagnostic criteria for recurrent major depressive disorder (MDD) or single-episode MDD; * At the start of the screening phase, participants' score on the 17-item Hamilton Depression Rating Scale (HAMD-17) must be ≥ 17; * At the start of the screening phase, participants have not been treated with medication for their current depressive episode; * At the start of the screening phase, participants are intended to be treated with a single antidepressant medication, Escitalopram; * The HAMD-17 score after two weeks of treatment with the maximum tolerated dose of escitalopram was reduced by less than 20% compared with the HAMD-17 score at screening; * Participants must have an education level above primary school and be able to understand the content of the scale; * Participants sign the informed consent form. Exclusion Criteria (Exclude if 1 criterion is met): * According to DSM-5 criteria, currently or previously diagnosed as bipolar disorder, neurodevelopmental disorder, neurocognitive disorder, schizophrenia spectrum and other psychotic disorders, substance-related and addiction disorders; * Accompanied by significant psychotic symptoms (delusions, hallucinations, etc.); * The patient currently has severe or unstable central nervous system, cardiovascular, respiratory, liver, kidney, endocrine, blood system or other system diseases, and the researcher believes that the patient is not suitable for inclusion in this study; * The patient currently has a serious suicide risk, and the HAMD-17 suicide risk item is ≥3 points; * Suffering from inflammation-related diseases; * Suffering from gastrointestinal infections, tumors and other structural abnormalities of the digestive system, including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, etc.; * Previous history of gastrointestinal surgery; * Continuous use of antibiotics, probiotics, prebiotics or traditional Chinese medicine products for medical purposes for more than 2 weeks within 3 months before enrollment in the study; * Those who are allergic to capsule ingredients and contents; * Pregnant or lactating patients; * Patients who are unable (such as difficulty swallowing) or unwilling to swallow capsules; * Patients who received MECT treatment in the past 6 months.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Anding Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100088, China

  • Nangfang Hospital Affiliated of Southern Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510450, China

  • Shandong Daizhuang Hospital

    RECRUITING

    Jining, Shandong, 272000, China

  • The First Affiliated Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • The First Affiliated Hospital of Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • The Second People's Hospital of Dali Bai Autonomous Prefecture

    RECRUITING

    Dali, Yunnan, 671003, China

  • Tianjin Anding Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300202, China

  • West China Hospital Affiliated of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Wuhu Fourth People's Hospital

    RECRUITING

    Wuhu, Anhui, 241002, China

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