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Probiotic trial aims to ease perimenopause brain fog and mood swings

NCT ID NCT07590999

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a probiotic supplement can improve emotional processing, memory, and concentration in perimenopausal women aged 45-60. Participants will take either the probiotic or a placebo and complete computer tasks, questionnaires, and provide blood and stool samples. The goal is to see if changes in gut bacteria are linked to better mood and thinking.

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 106 people

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

Started

Nov 2025

Expected to finish

Jun 2027

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

45 to 60 years

Sex

Female participants only

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: * Female at birth * You are aged 45-60 years and in perimenopause (determined by changes in menstrual bleeding patterns (such as changes in cycle length of 7 days or longer in either direction from what is normal for you), AND vasomotor symptoms (e.g., hot flushes and sweats) AND mild to moderate mood or cognitive disturbances, or joint and muscle pain over the previous 12 months) * You are willing and able to give informed consent for participation in the study * You are sufficiently fluent in English to understand and complete tasks * You are at least 12 months post-natal * Willing to withhold from having grapefruit juice Exclusion Criteria: * Currently receive or seek treatment for any mental health condition * Have a BMI \>=30 OR \<=18.5 * Have lost or gained more than 10% of body weight in a short period (e.g., 6 months), as this can affect mood and cognition * Currently using hormonal contraception or have used hormonal contraception in the last 6 months * Have had gender reassignment surgery or gender-affirming hormone therapy * Had a head injury causing concussion or unconsciousness in the past 6 months * Participated in other studies that may influence mood, cognition, or gut health in the last three months * Are currently diagnosed with and/or treated for psychiatric or neurological disorders * Are on perimenopausal hormone replacement therapy (HRT) (e.g., estrogen, progesterone, testosterone) or other hormone-modulating medications (e.g., GLP-1 agonists, thyroxine replacement), as these can impact mood and cognitive functions * Currently use statins or have used statins in the last 6 months, as these may impact mood and cognitive functions * Participated in any other study with the same tasks in the last year * Currently use medications that influence cognition or mood, such as antidepressants, anxiolytics, antipsychotics, stimulants, mood-stabilizers, or cognitive-enhancing drugs * Have chronic or severe gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, celiac disease, or severe acid reflux; treatment with e.g., corticosteroids, antacids), as these conditions and treatments can affect the gut microbiota and immune responses differently from healthy individuals * Have a compromised immune system * Currently smoke, vape, or use any other nicotine products * Have a current diagnosis of cognitive impairment or neurodegenerative disorders (e.g., mild cognitive impairment, dementia), as these conditions could confound cognitive assessments. * Have severe medical conditions requiring ongoing medication that may independently affect cognition or mood (e.g., diabetes) * Currently or recently used antibiotics (last 3 months), as antibiotics may alter gut microbiota and interfere with probiotic effects * Currently or recently used probiotics or prebiotics or consumed fermented products (e.g., kimchi, kombucha, sauerkraut, kefir, etc.) on a regular basis (last 3 months), which might interfere with the study intervention * Have known allergies or intolerances to probiotics or components in the probiotic supplement. * Have substance abuse or dependence (e.g., alcohol, recreational drugs) that may affect mood and cognition. * Have Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (Long COVID) * Have had a hysterectomy * Are pregnant or lactating, as hormonal changes associated with these states could confound results. * Score of 20 or above on PHQ-9 depression questionnaire, indicating severe depression * Score of \>1 on PHQ-9 suicidality item, indicating significant suicidality (as assessed by medical on-site professionals

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As listed by the trial registrant

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How to take part

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  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Oxford, Department of Psychiatry

    RECRUITING

    Oxford, England, OX3 7JX, United Kingdom

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