OxPALM: Oxford Study on Probiotics and Low Mood
Launched by UNIVERSITY OF OXFORD · Jan 10, 2019
Trial Information
Current as of September 07, 2025
Unknown status
Keywords
ClinConnect Summary
Current antidepressant treatments, which largely target monoamine pathways, are efficacious in treating many aspects of major depression, however it is estimated that more than 30% of depressed patients fail to respond to standard antidepressant medications. Thus, there is a strong clinical need to identify and investigate novel treatment strategies that target different pathways involved in the pathophysiology of mood disorders.
There is now compelling evidence for a link between the enteric microbiota and brain function. The proliferation of the Bifidobacteria and Lactobacilli strains in...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants are willing and able to give informed consent for participation in the study.
- • Male or female, aged between 18 and 55 years.
- • Body mass index (BMI) within the range of 18.5 - 30 kg/m2.
- • Sufficiently fluent in English to understand the tasks and instructions.
- • Score between 5 and 19 on the Patient Health Questionnaire (PHQ-9).
- • Participants not judged to be at risk of suicide or self-harm (as measured using the SCID) and/or in need of immediate treatment to the discretion of the Investigators.
- Exclusion Criteria:
- • Current history of Axis I psychiatric disorder except for depression or anxiety;
- • Current intake (or intention to take) any medication that may affect the outcomes, including medications affecting brain processing, sedation, and motility (examples include antidepressants, anxiolytics, among others);
- • Current psychological therapy;
- • Major medical disorders (including diseases affecting the human gastrointestinal tract);
- • Intake of any other food supplements which, in the opinion of the Investigators, may affect the results;
- • Any significant change in diet which, to the discretion of the Investigators, may affect the results;
- • Recent participation in another research trial which, to the discretion of the Investigators, may affect the results (for example, using the same / a similar battery of cognitive / emotional tasks in the last 3 months);
- • Dyslexia (given the nature of the computer tasks);
- • Any other significant finding arising during the screening/selection process which, in the opinion of the Investigators, may influence the participant's ability to take part in the study or the study results.
About University Of Oxford
The University of Oxford, a prestigious institution renowned for its excellence in research and education, serves as a leading clinical trial sponsor dedicated to advancing medical science and improving patient care. With a rich history of innovation and a multidisciplinary approach, the university leverages its extensive expertise in various fields, including medicine, public health, and biomedical research, to conduct rigorous clinical trials. Collaborating with healthcare professionals, industry partners, and regulatory bodies, the University of Oxford aims to translate groundbreaking research findings into effective therapies and interventions, contributing to the global effort of enhancing health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oxford, Oxfordshire, United Kingdom
Patients applied
Trial Officials
Phil Burnet, PhD
Principal Investigator
University of Oxford
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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