NCT04772664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 16, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

February 23, 2021

Last Update Submit

March 13, 2024

Conditions

Depressive Disorder, Major

Keywords

depressionvagal functionmultispecies probioticheart rate variability

Outcome Measures

Primary Outcomes (1)

  • Change of Vagal function

    Heart rate variability parameters (logRSA; SDNN)

    4 measurements with 24-hr heart rate variability at study entry, one week after, 1 month after and after 3 months

Secondary Outcomes (12)

  • Change of C-reactive protein (CRP)

    4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)

  • Change of Interleukine-6 (IL-6)

    4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)

  • Change of Oxytocin

    4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)

  • Change of Gut microbiome analysis

    4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)

  • Change of Body mass index

    4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)

  • +7 more secondary outcomes

Study Arms (4)

Participants with Major Depression receiving a multi-strain probiotic

EXPERIMENTAL

Participants with Major Depression receiving a multi-strain probiotic

Dietary Supplement: Multispecies-Probiotic

Participants mit Major Depression receiving a placebo

PLACEBO COMPARATOR

Participants mit Major Depression receiving a placebo

Dietary Supplement: Placebo Supplement

Healthy volunteers receiving a multi-strain probiotic

EXPERIMENTAL

Healthy volunteers receiving a multi-strain probiotic

Dietary Supplement: Multispecies-Probiotic

Healthy volunteers receiving a placebo

PLACEBO COMPARATOR

Healthy volunteers receiving a placebo

Dietary Supplement: Placebo Supplement

Interventions

Multispecies-ProbioticDIETARY_SUPPLEMENT

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.

Also known as: Omnibiotic-SR
Healthy volunteers receiving a multi-strain probioticParticipants with Major Depression receiving a multi-strain probiotic
Placebo SupplementDIETARY_SUPPLEMENT

Participants in the placebo group receive 2x3 gram of a placebo supplement not containing probiotic strains.

Also known as: Placebo
Healthy volunteers receiving a placeboParticipants mit Major Depression receiving a placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consenct
  • confirmed diagnosis of depression according to ICD-10 or DSM-V
  • age between 18 and 65 years

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 26, 2021

Study Start

August 16, 2021

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)