Probiotic Intake and Perimenopausal Psychological Assessments

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-60
SponsorUniversity of Oxford

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Multi-strain probiotic
  • Placebo

Treatment groups

106 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Oxford

Lead sponsor

ADM Protexin

Collaborator