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

Primary Purpose

Depressive Disorder, Major

Status

Recruiting

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Multispecies-Probiotic

Placebo Supplement

About this trial

This is an interventional basic science trial for Depressive Disorder, Major focused on measuring depression, vagal function, multispecies probiotic, heart rate variability

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Medical University of GrazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Participants with Major Depression receiving a multi-strain probiotic

Participants mit Major Depression receiving a placebo

Healthy volunteers receiving a multi-strain probiotic

Healthy volunteers receiving a placebo

Arm Description

Participants with Major Depression receiving a multi-strain probiotic

Participants mit Major Depression receiving a placebo

Healthy volunteers receiving a multi-strain probiotic

Healthy volunteers receiving a placebo

Outcomes

Primary Outcome Measures

Change of Vagal function

Heart rate variability parameters (logRSA; SDNN)

Secondary Outcome Measures

Change of C-reactive protein (CRP)

CRP is measured from serum samples with a Cobas analyzer.

Change of Interleukine-6 (IL-6)

IL-6 is measured from serum samples with a Cobas analyzer.

Change of Oxytocin

Oxytocin will be measured from serum samples using ELISA

Change of Gut microbiome analysis

16S sequencing of gut microbiome samples, gut microbiota composition will be investigated with QIIME2 and characterized in terms of diversity (alpha-diversity, beta diversity) and differential bacterial abundance between time points.

Change of Body mass index

Weight will be measured with a calibrated scale, height will be measured with a non expandable tape. BMI will be calculated using the formula [kg/m2].

Mini-international neuropsychiatric interview (M.I.N.I.)

short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10

Change in Hamilton Scale for Depression (HAMD)

Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression

Beck Depression Inventory (BDI)

21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. The rating is as follows: 0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression

Change in Pittsburgh Sleep Quality Inventory (PSQI)

The PSQI is used to rate sleep quality. It includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.

Change in Adult Attachment Scale

The scale consists of 18 items scored on a 5 point likert-type scale. It measures adult attachment styles named "Secure", "Anxious" and "Avoidant", defined as: Secure = high scores on Close and Depend subscales, low score on Anxiety subscale Anxious = high score on Anxiety subscale, moderate scores on Close and Depend subscales Avoidant = low scores on Close, Depend, and Anxiety subscales

Change in "Wiener Ernährungsprotokoll"

24-hr food recall

Change in International Physical Activity Questionnaire

The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients. There are no validated cut-offs.

Full Information

NCT ID

NCT04772664

First Posted

February 23, 2021

Last Updated

March 13, 2023

Sponsor

Medical University of Graz

Collaborators

Allergosan

1. Study Identification

Unique Protocol Identification Number

NCT04772664

Brief Title

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

Acronym

ProBIO-HRV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 16, 2021 (Actual)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

December 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Graz

Collaborators

Allergosan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major

Keywords

depression, vagal function, multispecies probiotic, heart rate variability

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Participants with Major Depression receiving a multi-strain probiotic

Arm Type

Experimental

Arm Description

Participants with Major Depression receiving a multi-strain probiotic

Arm Title

Participants mit Major Depression receiving a placebo

Arm Type

Placebo Comparator

Arm Description

Participants mit Major Depression receiving a placebo

Arm Title

Healthy volunteers receiving a multi-strain probiotic

Arm Type

Experimental

Arm Description

Healthy volunteers receiving a multi-strain probiotic

Arm Title

Healthy volunteers receiving a placebo

Arm Type

Placebo Comparator

Arm Description

Healthy volunteers receiving a placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Multispecies-Probiotic

Other Intervention Name(s)

Omnibiotic-SR

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo Supplement

Other Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of Vagal function

Description

Heart rate variability parameters (logRSA; SDNN)

Time Frame

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

Secondary Outcome Measure Information:

Title

Change of C-reactive protein (CRP)

Description

CRP is measured from serum samples with a Cobas analyzer.

Time Frame

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

Title

Change of Interleukine-6 (IL-6)

Description

IL-6 is measured from serum samples with a Cobas analyzer.

Time Frame

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

Title

Change of Oxytocin

Description

Oxytocin will be measured from serum samples using ELISA

Time Frame

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

Title

Change of Gut microbiome analysis

Description

Time Frame

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

Title

Change of Body mass index

Description

Weight will be measured with a calibrated scale, height will be measured with a non expandable tape. BMI will be calculated using the formula [kg/m2].

Time Frame

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

Title

Mini-international neuropsychiatric interview (M.I.N.I.)

Description

short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10

Time Frame

at study entry

Title

Change in Hamilton Scale for Depression (HAMD)

Description

Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression

Time Frame

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

Title

Beck Depression Inventory (BDI)

Description

Time Frame

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

Title

Change in Pittsburgh Sleep Quality Inventory (PSQI)

Description

Time Frame

at study entry, after 7 days, after 4 weeks and after 3 months

Title

Change in Adult Attachment Scale

Description

Time Frame

at study entry, after 7 days, after 4 weeks and after 3 months

Title

Change in "Wiener Ernährungsprotokoll"

Description

24-hr food recall

Time Frame

at study entry, after 7 days, after 4 weeks and after 3 months

Title

Change in International Physical Activity Questionnaire

Description

The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients. There are no validated cut-offs.

Time Frame

at study entry, after 7 days, after 4 weeks and after 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sabrina Mörkl, DDr.

Phone

031638581743

sabrina.moerkl@medunigraz.at

First Name & Middle Initial & Last Name or Official Title & Degree

Eva Reininghaus, Prof.

Phone

031638580968

eva.reininghaus@medunigraz.at

Facility Information:

Facility Name

Medical University of Graz

City

Graz

State/Province

Styria

ZIP/Postal Code

8036

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sabrina Mörkl, Priv. Doz. DDr.

Phone

031638581743

12. IPD Sharing Statement

Plan to Share IPD

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

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