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Poop pills for better sleep? new study tests gut bacteria transplant for insomnia

NCT ID NCT05917379

Disease control Sponsor: Peking University Sixth Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested if transplanting healthy gut bacteria (fecal microbiota) can help people with chronic insomnia. 80 adults received either the bacteria or a placebo in capsules. Researchers measured sleep quality using sleep tests and questionnaires to see if the treatment improved sleep.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

80 people

The number who actually took part.

Started

Oct 2023

Finished

Jul 2025

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 60 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: 1. Diagnosed CID by DSM-5 2. 18-60 years old24 3. Body Mass Index (BMI) within the range of 18-24 kg/m² 4. No other pharmacologic treatment in the last month or at the stable maintenance stage (stable dose for more than two months) Exclusion Criteria: 1. Currently pregnant, planning pregnancy shortly, or breastfeeding 2. Undergoing or recently received immunosuppressive therapy, or severe immunosuppression (neutrophil count \<1500 cells/mm³, lymphocyte count \<500 cells/mm³) 3. Diagnosis of one or more specific gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, gastrointestinal tumors, pseudomembranous enteritis, gastrointestinal bleeding, enterocutaneous fistula, etc.) 4. Diseases with significant correlations to gut microbiota include Type 2 Diabetes, thyroid disorders, migraines, and autoimmune diseases 5. Ex-/intraintestinal organ infection 6. Abnormal liver or kidney function 7. Faecal occult blood test (+) 8. Suffering from chronic pain, restless leg syndrome, obstructive sleep apnea, or thyroid disorders. 9. Central nervous system disorders (e.g., epilepsy, Parkinson's disease, history of traumatic brain injury, cerebrovascular diseases, etc.) 10. Current smokers or alcohol drinkers 11. History of food or antibiotic allergies

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Cognitive Dysfunction Depression depressive disorder insomnia sleep disorder sleep-wake disorder

As listed by the trial registrant

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

Anxiety Cognitive impairment Depression Fecal microbiota transplantation Insomnia chronic Sleep disorder

Contacts and locations

Locations

  • Department of Physical Therapy, The Second Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453002, China

  • Department of Psychiatry, First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001, China

  • Department of Psychiatry, The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016, China

  • Department of Psychiatry, The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601, China

  • Hefei Fourth People's Hospital/Anhui Mental Health Center

    Hefei, Anhui, 230022, China

  • Institute of Brain Science and Brain-inspired Research, Shandong First Medical University and Shandong Academy of Medical Sciences

    Jinan, Shandong, 250117, China

  • Peking University Six Hospital

    Beijing, Beijing Municipality, 100191, China

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