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Gut-Brain link: prebiotics may improve sleep in poor sleepers

NCT ID NCT05239845

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This study tests whether taking a prebiotic supplement for 56 days can improve sleep quality, gut health, thinking, immune function, and stress in healthy adults who report poor sleep. Sixty-eight volunteers will be randomly assigned to receive either a prebiotic blend or a placebo. The goal is to see if changing gut bacteria can lead to better rest.

What this could mean

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

Active substance
Prebiotic blend (milk fat globule membrane, lactoferrin, polydextrose, galactooligosaccharides)
What this could lead to
If it works, this could point toward a natural supplement to improve sleep quality and reduce stress without medication.
What could go wrong
This is a small, early-stage study in healthy volunteers, so results may not apply to people with sleep disorders. The effects may be modest or no better than 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

68 people

The number who actually took part.

Started

Mar 2022

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

25 to 60 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: * Participants must self-assess themselves as being in good health. * Have a stable sleep/wake schedule (bedtime between 9pm and 1am and wake time between 6am and 10am at least 5 nights per week) * Aged 25 to 60 years at the time of randomisation * Fluent in English * Identify as a 'poor sleeper' as defined subjectively (i.e. poor sleep quality, unrefreshing sleep) and a total score of \>5 on the Pittsburgh Sleep Quality Index (PSQI). Exclusion Criteria: * Member of own household currently participating in this trial * Evidence of current or recent sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders), taking any medication which exerts sedative effects, affects the CNS and/or sleep, or be currently unwell with any illness that affects sleep (i.e. disorders of the CNS). An initial screening for sleep disorders will be conducted using the Sleep Disorders Symptom Checklist-25 (SDS-CL; Klingman et al., 2017). If a participant reports positively to any of the 25 questions in terms of being affected for three nights per week, or more, this will be followed up using a clinical interview according to the International Classification of Sleep Disorders (ICSD-3) to exclude on the basis of a sleep disorder * History of seizures or epilepsy * Shift working or have a history of shift work within the previous six months * Currently, or within the previous 8 weeks, consuming any prebiotic or probiotic products/supplements (including specifically oligosaccharides) * Participation in any other intervention research trials * Sleeping at a location other than their usual residence more than two nights per week during participation * Travel across multiple time zones within the last three months or have planned travel across multiple time zones during the study * Current or recent mood disturbances or Axis I disorders * Current misuse of alcohol and/or drugs * Current smoker * Recent (within the last 12 weeks) infection and/or use of antibiotic medication * Pregnant, seeking to become pregnant or lactating * Those using (including within the last 2 weeks) proton-pump inhibitors * Milk allergy

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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.

Contacts and locations

Locations

  • Northumbria Sleep Research, Northumbria University

    Newcastle, United Kingdom

  • Northumbria University

    Newcastle, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.