Pilot-study: Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve? ProBIO-HRV-study

Medical University of Graz1 site in 1 country86 target enrollmentAugust 16, 2021

ConditionsDepressive Disorder, Major

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depressive Disorder, Major
Sponsor: Medical University of Graz
Enrollment: 86
Locations: 1
Primary Endpoint: Change of Vagal function
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the effects of a multispecies probiotic on the function of the vagal nerve in patients with major depression and healthy participants in a single-center, randomized, placebo-controlled trial.

Detailed Description

After being informed about the study and potential risks, all participants giving written informed consent will be screened for eligibility for study entry and will be randomized in a double-blind manner to receive either a multistrain probiotic or a placebo for 3 months. At entry, 1 week after inclusion, 4 weeks after inclusion and 3 months (end of study) vagal activity will be measured using a 24hr electrocardiogram.

Registry

clinicaltrials.gov

Start Date

August 16, 2021

End Date

October 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medical University of Graz

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•informed consenct
•confirmed diagnosis of depression according to ICD-10 or DSM-V
•age between 18 and 65 years

Exclusion Criteria

•Suicidality
•no informed consent or no ability to provide consent
•cardiovascular disease
•pregnancy, breastfeeding
•alcohol or drug dependency
•other severe psychiatric or organic conditions (epilepsy, brain tumor, recent surgery)
•malignant diseases
•dementia (MMST\<20)
•severe autoimmune-disorder or immunosuppression (systemic lupus, HIV, multiple sclerosis)
•antibiotic therapy in the last month

Outcomes

Primary Outcomes

Change of Vagal function

Time Frame: 4 measurements with 24-hr heart rate variability at study entry, one week after, 1 month after and after 3 months

Heart rate variability parameters (logRSA; SDNN)

Secondary Outcomes

Change in Hamilton Scale for Depression (HAMD)(4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))
Change in Pittsburgh Sleep Quality Inventory (PSQI)(at study entry, after 7 days, after 4 weeks and after 3 months)
Change of Interleukine-6 (IL-6)(4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))
Change of Gut microbiome analysis(4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))
Mini-international neuropsychiatric interview (M.I.N.I.)(at study entry)
Change in Adult Attachment Scale(at study entry, after 7 days, after 4 weeks and after 3 months)
Change in "Wiener Ernährungsprotokoll"(at study entry, after 7 days, after 4 weeks and after 3 months)
Change of Oxytocin(4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))
Change of C-reactive protein (CRP)(4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))
Change of Body mass index(4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))
Change in International Physical Activity Questionnaire(at study entry, after 7 days, after 4 weeks and after 3 months)
Beck Depression Inventory (BDI)(Change in 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))