Status:
COMPLETED
Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve?
Lead Sponsor:
Medical University of Graz
Collaborating Sponsors:
Allergosan
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-65 years
Phase:
NA
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, ra...
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 man...
Eligibility Criteria
Inclusion
- informed consenct
- confirmed diagnosis of depression according to ICD-10 or DSM-V
- age between 18 and 65 years
Exclusion
- 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
Key Trial Info
Start Date :
August 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04772664
Start Date
August 16 2021
End Date
October 30 2023
Last Update
March 15 2024
Active Locations (1)
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1
Medical University of Graz
Graz, Styria, Austria, 8036