ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000675820

Ethics application status

Approved

Date submitted

11/03/2021

Date registered

3/06/2021

Date last updated

3/06/2021

Date data sharing statement initially provided

3/06/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Effects of a probiotic food supplement on depressive symptoms in adults

Scientific title

The effect of a probiotic food supplement on depressive symptoms in adults: A double-blind randomised placebo-controlled trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sub-threshold Depression

Condition category

Condition code

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Dietary supplement: Biome Lift probiotic

1 probiotic per day for 3 months taken as an oral tablet, where each probiotic contains 355mg of 4x109 CFU of a mixture of lyophilised probiotic strains of the following species:
• Lactobacillus fermentum
• Lactobacillus rhamnosus
• Lactobacillus plantarum
• Bifidobacterium longum

Adherence will be monitored by tablet return and count of blisters opened on tablet pack, plus tick boxes in dietary diaries.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Placebo

1 placebo per day for 3 months taken as an oral tablet, where each placebo contains 355mg of non-active ingredients including maltodextrin.

Control group

Placebo

Outcomes

Primary outcome [1]

Change in depression score between the intervention and control groups, using the Patient Health Questionnaire (PH9) self-report, brief questionnaire that measures depression.

Timepoint [1]

Weekly from baseline for 3 months post-commencement of intervention

Primary outcome [2]

Change in depression score between intervention and control groups, using the Depression, Anxiety and Stress Scale for the depression axis (DASS-21; self-report)

Timepoint [2]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Primary outcome [3]

Change in depression score between intervention and control groups, using the Beck Depression Inventory (BDI-II; self-report)

Timepoint [3]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Secondary outcome [1]

Change in outcome between intervention and control groups, using the Structured Clinical Interview for DSM-5 (SCID 5; clinically administered; depression module)

Timepoint [1]

Pre-intervention and post-intervention (12 weeks)

Secondary outcome [2]

Change in insulin assessed via blood sample collection between intervention and control groups

Timepoint [2]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Secondary outcome [3]

Gut microbiota composition changes assessed via fecal samples for differences between intervention and control groups.

Timepoint [3]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Secondary outcome [4]

Salivary cortisol changes as a biomarker of stress assessed via saliva sample collection, and differences between intervention and control groups

Timepoint [4]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Secondary outcome [5]

Change in gut symptoms and health, assessed via the Irritable bowel syndrome-severity scoring system (IBS-SSS)

Timepoint [5]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Secondary outcome [6]

Change in outcome between intervention and control groups, using the Depression, Anxiety and Stress Scale for the anxiety axis (DASS-21; self-report)

Timepoint [6]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Secondary outcome [7]

Change in outcome between intervention and control groups, using the Assessment of Quality of Life (AQOL-8; self-report; health-related quality of life)

Timepoint [7]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Secondary outcome [8]

Change in outcome between intervention and control groups, using the Perceived Stress Scale (PSS; self-report; stress perception measurement)

Timepoint [8]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Secondary outcome [9]

Change in outcome between intervention and control groups, using the Hospital Anxiety and Depression Scale (HADS; clinically administered; anxiety and depression score) (note this is a composite secondary outcome)

Timepoint [9]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Secondary outcome [10]

Change in hs-CRP assessed via blood sample collection between intervention and control groups

Timepoint [10]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Secondary outcome [11]

Change in plasma GSH, assessed via blood sample collection between intervention and control groups

Timepoint [11]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Secondary outcome [12]

Gut microbiota functional predictions and differences between intervention and control groups assessed via fecal samples

Timepoint [12]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Secondary outcome [13]

Change in outcome between intervention and control groups, using the Depression, Anxiety and Stress Scale for the stress axis (DASS-21; self-report)

Timepoint [13]

Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)

Eligibility

Key inclusion criteria

• Not in the underweight category (BMI greater than or equal to 18.5 kg/m2);
• Meet the criteria for subthreshold depression;
• Have not been taking antidepressants or other medications acting on the CNS for at least 6 weeks (all potential participants will be advised to not stop taking any medication prior to consulting their GP);

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Patients with comorbidity with substance use disorders or organic mental disorders;
• Patients with neurological conditions affecting the brain or other central functions;
• Patients with organic co-morbidities affecting, in particular, the gastrointestinal system, or autoimmune or chronic inflammatory conditions;
• Patients who are taking nutritional supplements containing vitamins, minerals or antioxidants in the six weeks before the start of the trial participation;
• Patients who have been taking antibiotics in the six weeks before the start of the trial participation;
• Patients who are pregnant or are breastfeeding;

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Yes - allocation is held by someone not involved with screening/recruitment/data collection

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation code created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

5/07/2021

Actual

Date of last participant enrolment

Anticipated

7/03/2022

Actual

Date of last data collection

Anticipated

4/07/2022

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Biome Australia Trading Pty Ltd

Address [1]

16 Dover St, Cremorne, Melbourne VIC 3121

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

Discipline of Dietetics & Human Nutrition, HS3, Kingsbury Drive, Bundoora, Victoria 3086

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe University Human Research Ethics Committee

Ethics committee address [1]

La Trobe University, Cnr of Plenty Rd & Kingsbury Drive, Bundoora, Victoria 3086, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/02/2021

Approval date [1]

15/03/2021

Ethics approval number [1]

HEC21032

Summary

Brief summary

Depression is a serious health condition that has a considerable negative impact on both physical and mental health. It is one of the leading causes of disease worldwide and represents a huge burden on health care costs. The possible therapeutic impact of dietary changes on mental illness has been receiving increasing attention. Dietary intervention for the treatment of major depressive episodes has shown promise. Some of the many biological pathways by which dietary improvement may influence depressive illness focus on inflammatory and oxidative stress pathways, as well as brain plasticity, while more recently new evidence has focused on the gut microbiota. The intestinal microbiota plays a crucial role in the bidirectional communication between the gut and brain (i.e. the so-called gut-brain axis). 
Probiotic supplementation can be viewed as a form of controlled dietary intervention that allows modification of the microbial environment. Recent demonstration that probiotic administration has positive effects on depressive feelings in healthy populations (Marotta et al 2019) suggests its possible role in the management for depression in clinical populations and as a non-invasive strategy to prevent depressive feelings in healthy individuals. 
The present study extends current knowledge on the beneficial effects of probiotics on mood (i.e., depression) and other aspects of psychological well-being, (e.g., anxiety, quality of life) and explores potential mediating factors (e.g., biomarkers of inflammation, stress and changes in the gut microbiome). The research question being addressed is whether 3-months of supplementation with the Biome Lift™ Probiotic can reduce severity of depressive symptoms?
For this double-blind, placebo-controlled trial, patients with subthreshold depression will be randomly assigned to an experimental or control group, involving a daily dose of probiotic or placebo, respectively, for 3-months. The findings of this study will contribute to the better understanding of the role that probiotic administration and consequent gut microbiota changes have on the gut-brain axis and their involvement in the etiology of depression and other psychological outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof George Moschonis

Address

La Trobe University, Level 4, Building HS3, Bundoora campus, Kingsbury Drive, Bundoora Victoria 3086

Country

Australia

Phone

+61 3 9479 3482

Fax

g.moschonis@latrobe.edu.au

Contact person for public queries

Name

George Moschonis

Address

La Trobe University, Level 4, Building HS3, Bundoora campus, Kingsbury Drive, Bundoora Victoria 3086

Country

Australia

Phone

+61 3 9479 3482

Fax

g.moschonis@latrobe.edu.au

Contact person for scientific queries

Name

George Moschonis

Address

La Trobe University, Level 4, Building HS3, Bundoora campus, Kingsbury Drive, Bundoora Victoria 3086

Country

Australia

Phone

+61 3 9479 3482

Fax

g.moschonis@latrobe.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

De-identified data from questionnaires and biological samples that underlies published results

When will data be available (start and end dates)?

Immediately following publication, and available for 7 years after publication.

Available to whom?

Only researchers who provide a methodologically sound proposal

Available for what types of analyses?

Only to achieve the aims in the approved proposal

How or where can data be obtained?

Upon request sent to Chief Investigator, A/Prof George Moschonis, who will approve access.
Email Address: g.moschonis@latrobe.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10986	Statistical analysis plan			g.moschonis@latrobe.edu.au
10987	Informed consent form			g.moschonis@latrobe.edu.au

Results publications and other study-related documents

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No additional documents have been identified.

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