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Probiotic Intake and Perimenopausal Psychological Assessments

NCT07590999 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-05-15

No results posted yet for this study

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, 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.

Conditions

  • Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive Perturbations
  • Perimenopause
  • Perimenopause-Related Depression
  • Perimenopausal Women

Interventions

DIETARY_SUPPLEMENT

Placebo

A microcrystalline cellulose-based capsule.

DIETARY_SUPPLEMENT

Multi-strain probiotic

A commercially available probiotic known to support gut health and is generally well-tolerated.

Sponsors & Collaborators

  • ADM Protexin

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Phil Burnet, Professor · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-12
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07590999 on ClinicalTrials.gov