Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve? (ProBIO-HRV)

Medical University of Graz

Status: Completed

Conditions: Depressive Disorder, Major

Treatments: Dietary Supplement: Multispecies-Probiotic; Dietary Supplement: Placebo Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT04772664

EK1019/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 4 patient groups, including a placebo group

Participants with Major Depression receiving a multi-strain probiotic

Experimental group

Description:

Participants with Major Depression receiving a multi-strain probiotic

Treatment:

Dietary Supplement: Multispecies-Probiotic

Participants mit Major Depression receiving a placebo

Placebo Comparator group

Description:

Participants mit Major Depression receiving a placebo

Treatment:

Dietary Supplement: Placebo Supplement

Healthy volunteers receiving a multi-strain probiotic

Experimental group

Description:

Healthy volunteers receiving a multi-strain probiotic

Treatment:

Dietary Supplement: Multispecies-Probiotic

Healthy volunteers receiving a placebo

Placebo Comparator group

Description:

Healthy volunteers receiving a placebo

Treatment:

Dietary Supplement: Placebo Supplement