Poop pills for depression? new study tests gut bacteria fix
NCT ID NCT06692361
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Depression - major depressive disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
9 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGBeijing, Beijing Municipality, 100088, China
-
Nangfang Hospital Affiliated of Southern Medical University
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510450, China
-
Shandong Daizhuang Hospital
RECRUITINGJining, Shandong, 272000, China
-
The First Affiliated Hospital of Hebei Medical University
RECRUITINGShijiazhuang, Hebei, 050000, China
-
The First Affiliated Hospital of Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310000, China
-
The Second People's Hospital of Dali Bai Autonomous Prefecture
RECRUITINGDali, Yunnan, 671003, China
-
Tianjin Anding Hospital
RECRUITINGTianjin, Tianjin Municipality, 300202, China
-
West China Hospital Affiliated of Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
-
Wuhu Fourth People's Hospital
RECRUITINGWuhu, Anhui, 241002, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can brain stimulation rewire how depressed patients learn from rewards?
- Can lay workers in uganda talk depression down?
- Can a computer model outsmart depression in older adults?
- Can a single shot of ketamine calm suicidal distress in the ER?
- Can a structured care pathway lift teen depression in primary care?
- Can talk therapy mend more than mood in marital crisis?