Cognition in perimenopause: the effect of transition stage.
Miriam T Weber, Leah H Rubin, Pauline M Maki
https://pubmed.ncbi.nlm.nih.gov/23615642Actively Recruiting
Phase Not Applicable
Age: 45Years - 60Years
FEMALE
ID07590999
The Effects of a Probiotic on Emotional Processing, Cognition, and the Gut Microbiome in Perimenopausal Women
Led by University of Oxford · Updated on 2026-05-15
106
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Oxford
Lead Sponsor
A
ADM Protexin
Collaborating Sponsor
AI-Summary
What this Trial Is About
Perimenopause is the transition leading up to menopause, marked by fluctuating hormone levels that can cause physical changes and increase the risk of depression and cognitive decline. Women in this stage often face memory and concentration challenges, and research suggests the gut-brain axis may influence these symptoms. This study evaluates whether a multi-strain probiotic supplement can affect emotional processing, cognitive function, and gut bacteria in perimenopausal women. Participants are randomly assigned to take either a probiotic containing Lactobacillus rhamnosus and Bifidobacterium longum or a placebo of microcrystalline cellulose capsules daily for 60 days. The study measures changes in emotional processing, memory, concentration, and gut microbiota composition before and after the intervention, using computer tasks, questionnaires, and biological samples including blood and stool. During the study, women will complete various emotional and cognitive tasks such as facial expression recognition and memory tests, alongside providing blood and stool samples to assess cortisol levels, inflammatory markers, metabolites, and gut microbiome changes. The main outcome is the Facial Expression Recognition Task at the end of 60 days. This research aims to understand the probiotic's impact on mood and cognition during perimenopause, with careful monitoring and data collection throughout the trial.
CONDITIONS
Brief Title
Probiotic Intake and Perimenopausal Psychological Assessments
Who Can Participate
Age: 45Years - 60Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female at birth
- Aged 45 to 60 years and in perimenopause with changes in menstrual bleeding patterns, vasomotor symptoms, and mild to moderate mood or cognitive disturbances or joint and muscle pain in the past 12 months
- Willing and able to give informed consent
- Fluent enough in English to understand and complete study tasks
- At least 12 months post-natal
- Willing to avoid grapefruit juice during the study
You will not qualify if you...
- Currently receiving or seeking treatment for any mental health condition
- Body mass index (BMI) of 30 or higher, or 18.5 or lower
- Lost or gained more than 10% of body weight in the last 6 months
- Using or used hormonal contraception within the last 6 months
- Had gender reassignment surgery or hormone therapy
- Head injury causing concussion or unconsciousness in past 6 months
- Participated in other studies affecting mood, cognition, or gut health in last 3 months
- Diagnosed or treated for psychiatric or neurological disorders
- Using perimenopausal hormone replacement therapy or hormone-modulating medications
- Using or used statins in last 6 months
- Participated in a similar study in the past year
- Using medications affecting cognition or mood (e.g., antidepressants, anxiolytics)
- Chronic or severe gastrointestinal diseases or related treatments
- Compromised immune system
- Currently smoke, vape, or use nicotine products
- Diagnosed with cognitive impairment or neurodegenerative disorders
- Severe medical conditions requiring ongoing medication affecting cognition or mood
- Used antibiotics in the last 3 months
- Regular use of probiotics, prebiotics, or fermented products in last 3 months
- Allergies or intolerance to probiotics or supplement components
- Substance abuse or dependence
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (Long COVID)
- Had a hysterectomy
- Pregnant or lactating
- Severe depression indicated by PHQ-9 score 20 or above
- Significant suicidality indicated by PHQ-9 suicidality item score above 1 as assessed on site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 60 days
Participants take either multi-strain probiotic or placebo capsules daily as part of the study intervention.
Baseline visit and end of 60-day intervention visit
Trial Site Locations
Total: 1 location
1
University of Oxford, Department of Psychiatry
Oxford, England, United Kingdom, OX3 7JX
Actively Recruiting
Loading map...
Research Team
P
Phil Burnet, Professor
S
Susannah Murphy, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Reconciling subjective memory complaints with objective memory performance in the menopausal transition.
Miriam T Weber, Mark Mapstone, Jennifer Staskiewicz...
https://pubmed.ncbi.nlm.nih.gov/22415562Cognitive and Emotional Effect of a Multi-species Probiotic Containing Lactobacillus rhamnosus and Bifidobacterium lactis in Healthy Older Adults: A Double-Blind Randomized Placebo-Controlled Crossover Trial.
Cristofer Ruiz-Gonzalez, Diana Cardona, Lola Rueda-Ruzafa...
https://pubmed.ncbi.nlm.nih.gov/38935259Acceptability, Tolerability, and Estimates of Putative Treatment Effects of Probiotics as Adjunctive Treatment in Patients With Depression: A Randomized Clinical Trial.
Viktoriya L Nikolova, Anthony J Cleare, Allan H Young...
https://pubmed.ncbi.nlm.nih.gov/37314797Guidelines for the evaluation and treatment of perimenopausal depression: summary and recommendations.
Pauline M Maki, Susan G Kornstein, Hadine Joffe...
https://pubmed.ncbi.nlm.nih.gov/30179986Menopause and cognitive impairment: A narrative review of current knowledge.
Délio Marques Conde, Roberto Carmignani Verdade, Ana L R Valadares...
https://pubmed.ncbi.nlm.nih.gov/34513605Depression During and After the Perimenopause: Impact of Hormones, Genetics, and Environmental Determinants of Disease.
Joyce T Bromberger, Cynthia Neill Epperson
https://pubmed.ncbi.nlm.nih.gov/30401549Metabolic and hormone influences on emotion processing during menopause.
Alison Berent-Spillson, Courtney Marsh, Carol Persad...
https://pubmed.ncbi.nlm.nih.gov/27622993Multispecies probiotic administration reduces emotional salience and improves mood in subjects with moderate depression: a randomised, double-blind, placebo-controlled study.
Rita Baião, Liliana P Capitão, Cameron Higgins...
https://pubmed.ncbi.nlm.nih.gov/35129111The Gut-Brain Axis: Influence of Microbiota on Mood and Mental Health.
Jeremy Appleton
https://pubmed.ncbi.nlm.nih.gov/31043907