Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve?
NCT ID: NCT04772664
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2021-08-16
2023-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Participants with Major Depression receiving a multi-strain probiotic
Participants with Major Depression receiving a multi-strain probiotic
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.
Participants mit Major Depression receiving a placebo
Participants mit Major Depression receiving a placebo
Placebo Supplement
Participants in the placebo group receive 2x3 gram of a placebo supplement not containing probiotic strains.
Healthy volunteers receiving a multi-strain probiotic
Healthy volunteers receiving a multi-strain probiotic
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.
Healthy volunteers receiving a placebo
Healthy volunteers receiving a placebo
Placebo Supplement
Participants in the placebo group receive 2x3 gram of a placebo supplement not containing probiotic strains.
Interventions
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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.
Placebo Supplement
Participants in the placebo group receive 2x3 gram of a placebo supplement not containing probiotic strains.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* confirmed diagnosis of depression according to ICD-10 or DSM-V
* age between 18 and 65 years
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Allergosan
UNKNOWN
Medical University of Graz
OTHER
Responsible Party
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Locations
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Medical University of Graz
Graz, Styria, Austria
Countries
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Other Identifiers
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EK1019/2021
Identifier Type: -
Identifier Source: org_study_id
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