NCT04772664

Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve?

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Multispecies-Probiotic	Participants in intervention group receive 2x3g of a multistrain probiotic containing Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus acidophilus W22, Lactobacillus casei W56, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus salivarius W24, Lactococcus lactis W19.
DIETARY_SUPPLEMENT	Placebo Supplement	Participants in the placebo group receive 2x3 gram of a placebo supplement not containing probiotic strains.

Timeline

• Start date: 2021-08-16
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2021-02-26
• Last updated: 2024-03-15

Locations

1 site across 1 country: Austria