RT Journal Article SR Electronic T1 Bugs and Brains, the Gut and Mental Health Study: a mixed-methods study investigating microbiota composition and function in anxiety, depression and irritable bowel syndrome JF BMJ Open JO BMJ Open FD British Medical Journal Publishing Group SP e043221 DO 10.1136/bmjopen-2020-043221 VO 11 IS 3 A1 Carra A Simpson A1 Orli S Schwartz A1 Djamila Eliby A1 Catherine A Butler A1 Katherine Huang A1 Neil O'Brien-Simpson A1 Bridget L Callaghan A1 Stuart G Dashper A1 Paul R Gooley A1 Sarah Whittle A1 Nick Haslam A1 Julian G Simmons YR 2021 UL http://bmjopen.bmj.com/content/11/3/e043221.abstract AB Introduction Research has highlighted relationships between the micro-organisms that inhabit our gastrointestinal tract (oral and gut microbiota) with host mood and gastrointestinal functioning. Mental health disorders and functional gastrointestinal disorders co-occur at high rates, although the mechanisms underlying these associations remain unclear. The Bugs and Brains Study aims to investigate complex relationships between anxiety/depression and irritable bowel syndrome (IBS) in two ways. First, its primary component will compare the gut and oral microbiota in females with anxiety/depression and/or IBS relative to controls, and investigate underlying physiological, endocrine and immune factors, as well as associations with diet and psychosocial factors. In an ancillary component, the study will also investigate gastrointestinal and mental health symptoms in a larger sample, and explore relationships with diet, exercise, oral health, substance use, medical history, early life adversity and psychosocial factors.Methods and analysis The Bugs and Brains Study aims to recruit 160 females to the primary component: (1) 40 controls; (2) 40 participants with a depressive/anxiety disorder, but no IBS; (3) 40 participants with IBS, but no depressive/anxiety disorder and (4) 40 participants with both depressive/anxiety disorder and IBS. Participation is completed within 1 month, and involves comprehensive questionnaires, anthropometrics, a diagnostic clinical interview, collection of two saliva samples, and stool, urine and hair samples. This study aims to use a systems biology approach to characterise oral and gut microbial composition and function using 16S rRNA gene sequencing and nuclear MR spectroscopy. As part of the ancillary component, it will collect questionnaire data from 1000 participants aged 18–40 years, capturing mental health, gastrointestinal health, oral health, diet and psychosocial factors.Ethics and dissemination Approval was granted by the University of Melbourne Human Research Ethics Committee (#1749221). All participants voluntarily provided informed consent. Results will be published in peer-reviewed journals and presented at scientific conferences.