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Gut bacteria for better sleep? probiotic trial launches

NCT ID NCT07498712

Symptom relief Sponsor: Lactomason Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a daily probiotic supplement called Limosilactobacillus reuteri LM1063 can improve sleep in healthy adults who have poor sleep quality. Over 8 weeks, 80 participants will take either the probiotic or a placebo, and researchers will measure sleep using both sleep lab tests and questionnaires. The goal is to see if this probiotic can be a safe, natural option for better sleep.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Limosilactobacillus reuteri LM1063 (a probiotic)
What this could lead to
If it works, this could point toward a natural, side-effect-free way to improve sleep quality in people with mild sleep issues.
What could go wrong
This is an early-stage trial with only 80 people, so results may not apply to everyone. The effect on sleep might be small or no better than a placebo.

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 80 people

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

Started

Jul 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

19 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy male or female adults aged 19 to 65. * Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher. * Voluntarily agreed to participate and signed the informed consent form. Exclusion Criteria: * Severe sleep disorders (Insomnia Severity Index ≥ 22 or ≤ 7). * Medical conditions causing sleep disorders (Sleep apnea, Restless legs syndrome, Depression, Narcolepsy, etc.). * Intake of medications affecting sleep within 1 month before the first visit. * Intake of probiotics or fermented milk products within 1 month before the first visit.

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Conditions

The condition(s) this trial relates to.

insomnia sleep-wake disorder

As listed by the trial registrant

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

Sleep quality Sleep wake disorders

How to take part

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

  1. The places running it

    1 site. 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

  • P&K Skin Research Center

    RECRUITING

    Seoul, Yeongdeungpo, 07236, South Korea

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