Gut feeling: probiotics as a novel treatment for depression

Lead Research Organisation: King's College London
Department Name: Psychological Medicine

Abstract

Novelty and Importance: This study will be the first double blind placebo controlled clinical trial to investigate the effect of a multi-strain probiotic administration both on clinical symptoms and on the gut microbiome in patients with depression. It will provide the foundation for the design of larger studies, and the identification of specific bacteria strains targeting particular symptoms.
Primary aim(s): 1) To determine whether probiotic administration over 12 weeks leads to a significant reduction in depressive and anxiety symptoms in patients with mild-moderate depression. 2) To investigate the effect of probiotic administration on psychological and blood-based biomarkers of depression (including emotional faces task and blood inflammatory markers). 3) To investigate the relationship between probiotic-induced change in gut microbiome and clinical symptoms of depression and anxiety.
Planned research methods and training provided: Clinical Trial Methods, use of clinical rating scales, blood taking, 16S microbiome profiling, Industrial placement.

Publications

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Studentship Projects

Project Reference Relationship Related To Start End Student Name
MR/N013700/1 01/10/2016 30/09/2025
2171139 Studentship MR/N013700/1 01/10/2018 30/06/2022 VIKTORIYA NIKOLOVA
 
Description ADM Probiotics/ Protexin 
Organisation Protexin
Country United Kingdom 
Sector Private 
PI Contribution We are conducting a clinical trial of probiotics in depression using Protexin's (now ADM Probiotics International) 'BioKult Advanced' product.
Collaborator Contribution Protexin have provided financial support to cover some of the clinical trial costs and to fund the neuroimaging arm of the study. They have also manufactured and supplied the probiotic and placebo capsules and packaging free of charge.
Impact Still ongoing
Start Year 2018
 
Title The PROMEX study 
Description This study assesses the effects of an 8-week double-blind placebo-controlled probiotic intervention ('BioKult Advanced') on the gut microbiome, inflammatory marker levels, brain activity and neurotransmitter levels in patients with MDD and their relationship to changes in mood. 
Type Therapeutic Intervention - Complementary
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2022
Development Status Under active development/distribution
Clinical Trial? Yes
Impact None yet (still under development/assessment) 
 
Description Adolescent Mental Health Advisory Group 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact Adolescents with mental illness and their carers attended a demonstration and short talk on gut microbiome/probiotics research and the importance of maintaining gut health through good diet and exercise for better mental health. There was a lively discussion, with attendees becoming more self-aware and providing own examples of times when their mental illness exacerbated gut issues or poor dietary choices worsened their mental health and vice-versa.
The group also provided suggestions on how to improve the communication of our research study to patient/carer groups, which helped us in future talks and study material preparation.
Year(s) Of Engagement Activity 2019
 
Description InSPIre the Mind article 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Invited blog article for the online mental health magazine "InSPIre the Mind", titled 'The Power of Gut Bacteria to Influence Mental Health'. This article intended to introduce a wider audience to our research as well as to the gut health perspective on mental health.
Year(s) Of Engagement Activity 2021
URL https://www.inspirethemind.org/blog/the-power-of-gut-bacteria-to-influence-mental-health?rq=microbio...
 
Description Interview Medscape.com (1) 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Expert interview with journalist for article entitled "The Role of Probiotics in Mental Health" for Medscape.com.
The intended purpose was to provide a measured and balanced view on the topic and the current state of research.
Year(s) Of Engagement Activity 2021
URL https://www.medscape.com/viewarticle/958764
 
Description Interview Medscape.com (2) 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Response to media enquiry for an article about our publication in JAMA Psychiatry (doi: 10.1001/jamapsychiatry.2021.2573).
Year(s) Of Engagement Activity 2021
URL https://www.medscape.com/viewarticle/959154#vp_2
 
Description New and Emerging Treatments Masterclass - Maudsley Learning 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact This masterclass aimed to introduce clinicians to the major new interventions in psychiatry with strong or promising clinical evidence, including gut microbiome-targeting interventions. Panel discussion & Q&A sessions were held. 50 clinicians attended.
Year(s) Of Engagement Activity 2020
 
Description Podcast - JAMA Psychiatry 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Extensive interview for the JAMA Psychiatry monthly podcast series released alongside our publication in JAMA (doi:10.1001/jamapsychiatry.2021.2573). Intended to increase accessibility to the article to general audiences
Year(s) Of Engagement Activity 2021
URL https://edhub.ama-assn.org/jn-learning/audio-player/18641793
 
Description Press release 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Press release from King's College London including author quotes regarding our publication in JAMA Psychiatry (doi:10.1001/jamapsychiatry.2021.2573) intended to increase the visibility and impact of the publication and generate media interest.
Year(s) Of Engagement Activity 2021
URL https://www.kcl.ac.uk/news/common-factors-within-the-gut-associated-with-depression-and-bipolar-diso...