At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Multi-strain probiotic (supplement), Placebo (supplement)
- How long the study runs
- Study runs about 19 months (dates as stated)
- About the drug or intervention
- Multi-strain probiotic — supplement: A commercially available probiotic known to support gut health and is generally well-tolerated. · Placebo — supplement: A microcrystalline cellulose-based capsule.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 45 Years to 60 Years
- Who
- Female
- Number of participants
- 106
- Started
- 2025-11-12
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for emotional processing and cognitive function in perimenopausal women experiencing cognitive perturbations
- • NA - 106 participants
- • Recent evidence suggests multi-strain probiotics containing Lactobacillus rhamnosus and Bifidobacterium longum have been found to enhance emotional processing and reduce salience to negative cues in studies involving people with mood disorders, as well as improve cognitive functions, such as memory and concentration, in healthy participants
Who can take part?
- • Ages 45 Years to 60 Years
- • Diagnosed with emotional processing and cognitive function in perimenopausal women experiencing cognitive perturbations
- • Female only
Where?
- • Oxford - University of Oxford, Department of Psychiatry
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Recent evidence suggests multi-strain probiotics containing Lactobacillus rhamnosus and Bifidobacterium longum have been found to enhance emotional processing and reduce salience to negative cues in studies involving people with mood disorders, as well as improve cognitive functions, such as memory and concentration, in healthy participants. By administering computer-based tasks, questionnaires and checking biological measures (cortisol, immune markers, blood metabolites, gut microbiota) using blood and faecal samples, this experimental medicine study aims to investigate whether a probiotic supplement has an effect on emotional processing and cognition in perimenopausal women. We also aim to study changes in gut bacteria from stool samples before and after taking the supplement to see if any microbiome changes are associated with any effects in emotional processing, cognitive function, and biological markers.
More detail
Perimenopause, the transition period leading up to menopause, involves fluctuating levels of oestrogen and other hormones, contributing to a variety of physical and metabolic changes. It is also a period associated with an increased risk of depression and a decline in cognitive functioning. When compared to the pre-perimenopausal period, perimenopausal women are two to five times more susceptible to experiencing depressive episodes. Cognitive decline, including memory and concentration issues, is also prevalent, with an estimated 44-62% of individuals reporting challenges with memory. Research often highlights the role of the gut-brain axis, where the gut microbiota influences cognitive function and emotional processing via neurotransmitters, inflammatory markers, and stress response pathways. Recent evidence suggests that multi-strain probiotics containing Lactobacillus rhamnosus and Bifidobacterium longum enhance emotional processing and reduce salience to negative cues in studies involving people with mood disorders, as well as improving cognitive functions, such as memory and concentration, in healthy participants. One 8-week study also found preliminary evidence supporting the potential of probiotics as a safe and effective adjunctive treatment for major depressive disorder in individuals with incomplete responses to antidepressant medication. Given these observed benefits, the investigation into the effects of multi-strain probiotics to address emotional processing and cognitive disturbances and perturbations in a perimenopausal population is lacking. With the increasing demand for natural, non-pharmacological therapeutic interventions to manage perimenopausal symptoms, this project could provide valuable evidence supporting the use of probiotics as a beneficial adjunct therapy in perimenopausal health management. The current proposal will assess the effects of a commercial probiotic on emotional processing and cognitive function in perimenopausal women, alongside changes in gut microbial composition that may mediate any observed metabolic changes and effects on inflammatory markers and metabolites. This is an important next step in elucidating the role probiotics may play in perimenopause and in generating data to guide future clinical applications of probiotics in managing perimenopausal symptoms.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 45 Years - 60 Years
- Who can join: Female only
What the study is looking for
- ✓Female at birth
- ✓You are willing and able to give agreement to take part 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
Who cannot take part
- ✗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...
- ✗Currently using hormonal contraception or have used hormonal contraception in the last 6 months
- ✗Have had gender reassignment surgery or gender-affirming hormone therapy
See the full criteria
Where Is This Study? (1 UK site)
University of Oxford, Department of Psychiatry
Oxford OX3 7JX, United Kingdom
How to Get in Touch
Phil Burnet, Professor
Sponsor contactCONTACT
Susannah Murphy, Professor
Sponsor contactCONTACT
