Clinical trial NCT04772664: Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve?
Official title: Pilot-study: Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve? ProBIO-HRV-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: depression
vagal function
multispecies probiotic
heart rate variability
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Allergosan
First posted: 2021-02-26
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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
* misuse of laxative
* acute infections
* diarrhoea
* gastrointestinal surgeries (except appendectomy)
* no probiotic intake in the last 6 months
* no regular intake of other supplements, probiotics or antibiotics during the study

Primary outcomes:
measure: Change of Vagal function
timeFrame: 4 measurements with 24-hr heart rate variability at study entry, one week after, 1 month after and after 3 months
Secondary outcomes:
measure: Change of C-reactive protein (CRP)
timeFrame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
measure: Change of Interleukine-6 (IL-6)
timeFrame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
measure: Change of Oxytocin
timeFrame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
measure: Change of Gut microbiome analysis
timeFrame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
measure: Change of Body mass index
timeFrame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
measure: Mini-international neuropsychiatric interview (M.I.N.I.)
timeFrame: at study entry
measure: Change in Hamilton Scale for Depression (HAMD)
timeFrame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
measure: Beck Depression Inventory (BDI)
timeFrame: Change in 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)
measure: Change in Pittsburgh Sleep Quality Inventory (PSQI)
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change in Adult Attachment Scale
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change in "Wiener Ernährungsprotokoll"
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
measure: Change in International Physical Activity Questionnaire
timeFrame: at study entry, after 7 days, after 4 weeks and after 3 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
References: