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New treatment option for Emotional Processing and Cognitive Function in Perimenopausal Women...
Official title Probiotic Intake and Perimenopausal Psychological Assessments
ClinicalTrials.gov ID: NCT07590999
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 60, women only
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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...
- 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
What rules you out
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Oxford, England, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oxford, England, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.