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 type | Interventional |
|---|---|
| Ages | 45 Years to 60 Years |
| Sex | Women only |
| Enrollment | 106 (estimated) |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford, England) |
| Status | Recruiting |
| Started | November 12, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT07590999 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
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University of Oxford, Department of Psychiatry
Oxford, England, United Kingdom Recruiting
Study contacts
- Principal investigator: Phil Burnet, Professor — University of Oxford
- Study coordinator: Phil Burnet, Professor
- Email: phil.burnet@psych.ox.ac.uk
- Phone: +44 1865 618327
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.