Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive PerturbationsPIPPANCT07590999
Probiotic Intake and Perimenopausal Psychological Assessments
A study testing Multi-strain probiotic in people with Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive Perturbations and Perimenopause, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive Perturbations, Perimenopause, Perimenopause-Related Depression
- What is being tested?
- Multi-strain probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Nov 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to 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 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford, Department of Psychiatry
Oxford, England, OX3 7JX
Phil Burnet, Professor, +44 1865 618327, phil.burnet@psych.ox.ac.uk
Susannah Murphy, Professor, +44 1865 618313, susannah.murphy@psych.ox.ac.uk
About this study
Official title: The Effects of a Probiotic on Emotional Processing, Cognition, and the Gut Microbiome in Perimenopausal Women
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.
Read the detailed description
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.
- Conditions
- Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive Perturbations, Perimenopause, Perimenopause-Related Depression, Perimenopausal Women
- Being tested
- Multi-strain probiotic, Placebo
- Keywords
- perimenopause, menopause, gut microbiome and perimenopause, cognition and perimenopause, emotional processing and perimenopause, mood and perimenopause, gut microbiome and cognition, probiotics, probiotic, gut microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-strain probioticDietary supplement
A commercially available probiotic known to support gut health and is generally well-tolerated.
PlaceboDietary supplement
A microcrystalline cellulose-based capsule.
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Placebo comparator | Participants randomised to the Placebo condition will be taking four microcrystalline cellulose powder placebo capsules daily for 60 days. Receives: Dietary Supplement: Placebo |
| Interventional/Treatment | Experimental | Participants randomised to the Probiotic condition will be taking four multi-strain probiotic capsules daily for 60 days. Receives: Dietary Supplement: Multi-strain probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Expression Recognition Task (FERT)
Accuracy, reaction time and misclassifications on the FERT compared between probiotic and placebo groups.
Measured: End of the 60-day intervention
Secondary outcomes (11)
Emotional Categorisation Task
Accuracy and reaction time performance on emotional word categorization task compared between probiotic and placebo groups.
Measured: End of the 60-day intervention
Emotional word recall/recognition task
Performance on emotional word recall (hits and false alarms) and recogntion (hits, false alarms and reaction time) compared between probiotic and placebo groups
Measured: End of the 60-day intervention
Digit Span Task
Maximum span length compared between probiotic and placebo groups
Measured: End of the 60-day intervention
Emotional Go/No-Go (EGNG)
Cognitive control and inhibitory control assessed using the EGNG task, including commission errors, omission errors, and reaction time to emotionally valenced stimuli. Performance will be compared between probiotic and placebo groups at post-intervention.
Measured: Post-intervention (end of 60-day intervention)
Probabilistic Reversal Learning (PRL) Task
Cognitive flexibility and reward-based learning assessed using the PRL task, including measures such as response accuracy, reversal errors, and sensitivity to reward and punishment. Performance will be compared between probiotic and placebo groups at post-intervention.
Measured: Post-intervention (end of 60-day intervention)
N-back Task
Working memory performance assessed using the n-back task, including accuracy and reaction time across task conditions. Performance will be compared between probiotic and placebo groups at post-intervention.
Measured: Post-intervention (end of 60-day intervention)
Auditory Verbal Learning Test (AVLT)
Verbal learning and memory assessed using the AVLT, including measures of immediate recall, delayed recall, and recognition memory. Performance will be compared between probiotic and placebo groups at post-intervention.
Measured: Post-intervention (end of 60-day intervention)
Serum cortisol
Serum cortisol concentration assessed using ELISA compared between the placebo and probiotic groups
Measured: Baseline and end of 60-day intervention
Inflammatory markers
Inflammatory marker concentrations (CRP, IL-1b, TNF-alpha, IL-6) assessed using ELISA compared between placebo and probiotic groups
Measured: Baseline and end of 60-day intervention
Serum metabolites
Serum metabolite profiles assessed using ELISA compared between placebo and probiotic groups
Measured: Baseline and end of 60-day intervention
Gut microbiome composition
Gut microbiome composition assessed using stool samples, including measures of alpha diversity, beta diversity, and relative abundance of microbial taxa, compared between placebo and probiotic groups.
Measured: Baseline and end of 60-day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start12 Nov 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive PerturbationsStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into one of two groups, each undergoing 60 days of either 1) Placebo or 2) Probiotic.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- ADM Protexin
- Responsible party
- Sponsor
- Investigators
- Phil Burnet, Professor, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590999
- Sponsor's protocol ID
- PIPPA Study (735575)
- Acronym
- PIPPA
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weber MT, Rubin LH, Maki PM. Cognition in perimenopause: the effect of transition stage. Menopause. 2013 May;20(5):511-7. doi: 10.1097/gme.0b013e31827655e5.
PubMed 23615642Weber MT, Mapstone M, Staskiewicz J, Maki PM. Reconciling subjective memory complaints with objective memory performance in the menopausal transition. Menopause. 2012 Jul;19(7):735-41. doi: 10.1097/gme.0b013e318241fd22.
PubMed 22415562Ruiz-Gonzalez C, Cardona D, Rueda-Ruzafa L, Rodriguez-Arrastia M, Ropero-Padilla C, Roman P. Cognitive 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. Probiotics Antimicrob Proteins. 2025 Oct;17(5):3525-3537. doi: 10.1007/s12602-024-10315-2. Epub 2024 Jun 27.
PubMed 38935259Nikolova VL, Cleare AJ, Young AH, Stone JM. Acceptability, Tolerability, and Estimates of Putative Treatment Effects of Probiotics as Adjunctive Treatment in Patients With Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Aug 1;80(8):842-847. doi: 10.1001/jamapsychiatry.2023.1817.
PubMed 37314797Maki PM, Kornstein SG, Joffe H, Bromberger JT, Freeman EW, Athappilly G, Bobo WV, Rubin LH, Koleva HK, Cohen LS, Soares CN; Board of Trustees for The North American Menopause Society (NAMS) and the Women and Mood Disorders Task Force of the National Network of Depression Centers. Guidelines for the evaluation and treatment of perimenopausal depression: summary and recommendations. Menopause. 2018 Oct;25(10):1069-1085. doi: 10.1097/GME.0000000000001174.
PubMed 30179986Conde DM, Verdade RC, Valadares ALR, Mella LFB, Pedro AO, Costa-Paiva L. Menopause and cognitive impairment: A narrative review of current knowledge. World J Psychiatry. 2021 Aug 19;11(8):412-428. doi: 10.5498/wjp.v11.i8.412. eCollection 2021 Aug 19.
PubMed 34513605Bromberger JT, Epperson CN. Depression During and After the Perimenopause: Impact of Hormones, Genetics, and Environmental Determinants of Disease. Obstet Gynecol Clin North Am. 2018 Dec;45(4):663-678. doi: 10.1016/j.ogc.2018.07.007. Epub 2018 Oct 25.
PubMed 30401549Berent-Spillson A, Marsh C, Persad C, Randolph J, Zubieta JK, Smith Y. Metabolic and hormone influences on emotion processing during menopause. Psychoneuroendocrinology. 2017 Feb;76:218-225. doi: 10.1016/j.psyneuen.2016.08.026. Epub 2016 Sep 5.
PubMed 27622993Baiao R, Capitao LP, Higgins C, Browning M, Harmer CJ, Burnet PWJ. Multispecies probiotic administration reduces emotional salience and improves mood in subjects with moderate depression: a randomised, double-blind, placebo-controlled study. Psychol Med. 2023 Jun;53(8):3437-3447. doi: 10.1017/S003329172100550X. Epub 2022 Feb 7.
PubMed 35129111Appleton J. The Gut-Brain Axis: Influence of Microbiota on Mood and Mental Health. Integr Med (Encinitas). 2018 Aug;17(4):28-32.
PubMed 31043907
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Probiotic on Emotional Processing, Cognition, and the Gut Microbiome in Perimenopausal Women
- ClinicalTrials.gov ID
- NCT07590999
- Acronym / sponsor ID
- PIPPA / PIPPA Study (735575)
- Conditions
- Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive Perturbations, Perimenopause, Perimenopause-Related Depression, Perimenopausal Women
- Keywords
- perimenopause, menopause, gut microbiome and perimenopause, cognition and perimenopause, emotional processing and perimenopause, mood and perimenopause, gut microbiome and cognition, probiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- ADM Protexin
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are randomized into one of two groups, each undergoing 60 days of either 1) Placebo or 2) Probiotic.
| Arm | Type | Receives |
|---|---|---|
| Patient Group | Placebo comparator | Dietary Supplement: PlaceboParticipants randomised to the Placebo condition will be taking four microcrystalline cellulose powder placebo capsules daily for 60 days. |
| Interventional/Treatment | Experimental | Dietary Supplement: Multi-strain probioticParticipants randomised to the Probiotic condition will be taking four multi-strain probiotic capsules daily for 60 days. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-strain probioticA commercially available probiotic known to support gut health and is generally well-tolerated. | Dietary supplement | Interventional/Treatment |
| PlaceboA microcrystalline cellulose-based capsule. | Dietary supplement | Patient Group |
Primary outcome
Facial Expression Recognition Task (FERT)
Time frame: End of the 60-day intervention
Accuracy, reaction time and misclassifications on the FERT compared between probiotic and placebo groups.
11 secondary outcomes
Emotional Categorisation Task
Time frame: End of the 60-day intervention
Emotional word recall/recognition task
Time frame: End of the 60-day intervention
Digit Span Task
Time frame: End of the 60-day intervention
Emotional Go/No-Go (EGNG)
Time frame: Post-intervention (end of 60-day intervention)
Probabilistic Reversal Learning (PRL) Task
Time frame: Post-intervention (end of 60-day intervention)
N-back Task
Time frame: Post-intervention (end of 60-day intervention)
Auditory Verbal Learning Test (AVLT)
Time frame: Post-intervention (end of 60-day intervention)
Serum cortisol
Time frame: Baseline and end of 60-day intervention
Inflammatory markers
Time frame: Baseline and end of 60-day intervention
Serum metabolites
Time frame: Baseline and end of 60-day intervention
Gut microbiome composition
Time frame: Baseline and end of 60-day intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 23615642Weber MT, Rubin LH, Maki PM. Cognition in perimenopause: the effect of transition stage. Menopause. 2013 May;20(5):511-7. doi: 10.1097/gme.0b013e31827655e5.
- Background: PubMed 22415562Weber MT, Mapstone M, Staskiewicz J, Maki PM. Reconciling subjective memory complaints with objective memory performance in the menopausal transition. Menopause. 2012 Jul;19(7):735-41. doi: 10.1097/gme.0b013e318241fd22.
- Background: PubMed 38935259Ruiz-Gonzalez C, Cardona D, Rueda-Ruzafa L, Rodriguez-Arrastia M, Ropero-Padilla C, Roman P. Cognitive 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. Probiotics Antimicrob Proteins. 2025 Oct;17(5):3525-3537. doi: 10.1007/s12602-024-10315-2. Epub 2024 Jun 27.
- Background: PubMed 37314797Nikolova VL, Cleare AJ, Young AH, Stone JM. Acceptability, Tolerability, and Estimates of Putative Treatment Effects of Probiotics as Adjunctive Treatment in Patients With Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Aug 1;80(8):842-847. doi: 10.1001/jamapsychiatry.2023.1817.
- Background: PubMed 30179986Maki PM, Kornstein SG, Joffe H, Bromberger JT, Freeman EW, Athappilly G, Bobo WV, Rubin LH, Koleva HK, Cohen LS, Soares CN; Board of Trustees for The North American Menopause Society (NAMS) and the Women and Mood Disorders Task Force of the National Network of Depression Centers. Guidelines for the evaluation and treatment of perimenopausal depression: summary and recommendations. Menopause. 2018 Oct;25(10):1069-1085. doi: 10.1097/GME.0000000000001174.
- Background: PubMed 34513605Conde DM, Verdade RC, Valadares ALR, Mella LFB, Pedro AO, Costa-Paiva L. Menopause and cognitive impairment: A narrative review of current knowledge. World J Psychiatry. 2021 Aug 19;11(8):412-428. doi: 10.5498/wjp.v11.i8.412. eCollection 2021 Aug 19.
- Background: PubMed 30401549Bromberger JT, Epperson CN. Depression During and After the Perimenopause: Impact of Hormones, Genetics, and Environmental Determinants of Disease. Obstet Gynecol Clin North Am. 2018 Dec;45(4):663-678. doi: 10.1016/j.ogc.2018.07.007. Epub 2018 Oct 25.
- Background: PubMed 27622993Berent-Spillson A, Marsh C, Persad C, Randolph J, Zubieta JK, Smith Y. Metabolic and hormone influences on emotion processing during menopause. Psychoneuroendocrinology. 2017 Feb;76:218-225. doi: 10.1016/j.psyneuen.2016.08.026. Epub 2016 Sep 5.
- Background: PubMed 35129111Baiao R, Capitao LP, Higgins C, Browning M, Harmer CJ, Burnet PWJ. Multispecies probiotic administration reduces emotional salience and improves mood in subjects with moderate depression: a randomised, double-blind, placebo-controlled study. Psychol Med. 2023 Jun;53(8):3437-3447. doi: 10.1017/S003329172100550X. Epub 2022 Feb 7.
- Background: PubMed 31043907Appleton J. The Gut-Brain Axis: Influence of Microbiota on Mood and Mental Health. Integr Med (Encinitas). 2018 Aug;17(4):28-32.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phil Burnet, Professor principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-strain probiotic in people with Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive Perturbations and Perimenopause, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phil Burnet, Professor (+44 1865 618327, phil.burnet@psych.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Expression Recognition Task (FERT) (time frame: End of the 60-day intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07590999, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.