Clinical trial Recruiting at 1 site Interventional Ages 45 to 60 Women only

Probiotic Intake to See If It Helps Perimenopausal Women Think and Feel Better

Official title: The Effects of a Probiotic on Emotional Processing, Cognition, and the Gut Microbiome in Perimenopausal Women

Run by University of Oxford · NCT07590999 · Data updated 2026-11-12

We’re testing whether a multi-strain probiotic can improve emotional processing and cognitive function in perimenopausal women who have mood or cognitive concerns.

Quick facts

Study typeInterventional
Ages45 Years to 60 Years
SexWomen only
Enrollment106 (estimated)
SponsorUniversity of Oxford
Academic / other
Locations1 site (Oxford, England)
StatusRecruiting
StartedNovember 12, 2025
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedMay 15, 2026
Trial IDNCT07590999 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are women aged 45-60 in perimenopause with mild to moderate mood or cognitive disturbances and willing to provide samples and follow study procedures.

Probably not a fit

Individuals without perimenopause-related cognitive or mood symptoms or those with contraindications to probiotics may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study uses a placebo-controlled design to examine if daily probiotic supplements affect emotional processing, memory, and attention in perimenopausal women. Participants complete computer-based tasks and questionnaires, while researchers measure cortisol, immune markers, blood metabolites, and gut microbiota from blood and stool samples before and after 8 weeks of intervention. Biological and psychological data are analyzed to see if changes in the gut microbiome relate to any observed effects on mood or cognition. The trial explores potential links between the gut-brain axis and perimenopause-related cognitive and emotional symptoms.

Why it matters

Potential benefit: If successful, participants may experience improvements in mood and cognitive function during the perimenopause transition.

How similar studies have gone: Previous studies in mood disorders and healthy populations suggest probiotics can influence emotional processing and cognition, supporting the rationale for this perimenopause-focused trial.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University of Oxford, Department of Psychiatry
    Oxford, England, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.