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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] 303647 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sub-threshold Depression 321039 0
Condition category
Condition code
Mental Health 318841 318841 0 0
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] 319941 0
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] 326811 0
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] 326811 0
Weekly from baseline for 3 months post-commencement of intervention
Primary outcome [2] 327735 0
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] 327735 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Primary outcome [3] 327736 0
Change in depression score between intervention and control groups, using the Beck Depression Inventory (BDI-II; self-report)
Timepoint [3] 327736 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Secondary outcome [1] 392755 0
Change in outcome between intervention and control groups, using the Structured Clinical Interview for DSM-5 (SCID 5; clinically administered; depression module)


Timepoint [1] 392755 0
Pre-intervention and post-intervention (12 weeks)
Secondary outcome [2] 392756 0
Change in insulin assessed via blood sample collection between intervention and control groups
Timepoint [2] 392756 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Secondary outcome [3] 392757 0
Gut microbiota composition changes assessed via fecal samples for differences between intervention and control groups.
Timepoint [3] 392757 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Secondary outcome [4] 392758 0
Salivary cortisol changes as a biomarker of stress assessed via saliva sample collection, and differences between intervention and control groups
Timepoint [4] 392758 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Secondary outcome [5] 392759 0
Change in gut symptoms and health, assessed via the Irritable bowel syndrome-severity scoring system (IBS-SSS)
Timepoint [5] 392759 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Secondary outcome [6] 394144 0
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] 394144 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Secondary outcome [7] 394145 0
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] 394145 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Secondary outcome [8] 394146 0
Change in outcome between intervention and control groups, using the Perceived Stress Scale (PSS; self-report; stress perception measurement)
Timepoint [8] 394146 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Secondary outcome [9] 394147 0
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] 394147 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Secondary outcome [10] 394161 0
Change in hs-CRP assessed via blood sample collection between intervention and control groups
Timepoint [10] 394161 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Secondary outcome [11] 394162 0
Change in plasma GSH, assessed via blood sample collection between intervention and control groups
Timepoint [11] 394162 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Secondary outcome [12] 394189 0
Gut microbiota functional predictions and differences between intervention and control groups assessed via fecal samples
Timepoint [12] 394189 0
Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)
Secondary outcome [13] 396381 0
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] 396381 0
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?
No
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
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308067 0
Commercial sector/Industry
Name [1] 308067 0
Biome Australia Trading Pty Ltd
Country [1] 308067 0
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] 308831 0
None
Name [1] 308831 0
None
Address [1] 308831 0
None
Country [1] 308831 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308058 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 308058 0
La Trobe University, Cnr of Plenty Rd & Kingsbury Drive, Bundoora, Victoria 3086, Australia
Ethics committee country [1] 308058 0
Australia
Date submitted for ethics approval [1] 308058 0
02/02/2021
Approval date [1] 308058 0
15/03/2021
Ethics approval number [1] 308058 0
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 109374 0
A/Prof George Moschonis
Address 109374 0
La Trobe University, Level 4, Building HS3, Bundoora campus, Kingsbury Drive, Bundoora Victoria 3086
Country 109374 0
Australia
Phone 109374 0
+61 3 9479 3482
Fax 109374 0
Email 109374 0
g.moschonis@latrobe.edu.au
Contact person for public queries
Name 109375 0
A/Prof George Moschonis
Address 109375 0
La Trobe University, Level 4, Building HS3, Bundoora campus, Kingsbury Drive, Bundoora Victoria 3086
Country 109375 0
Australia
Phone 109375 0
+61 3 9479 3482
Fax 109375 0
Email 109375 0
g.moschonis@latrobe.edu.au
Contact person for scientific queries
Name 109376 0
A/Prof George Moschonis
Address 109376 0
La Trobe University, Level 4, Building HS3, Bundoora campus, Kingsbury Drive, Bundoora Victoria 3086
Country 109376 0
Australia
Phone 109376 0
+61 3 9479 3482
Fax 109376 0
Email 109376 0
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.TypeCitationLinkEmailOther DetailsAttachment
10986Statistical analysis plan  g.moschonis@latrobe.edu.au
10987Informed consent form  g.moschonis@latrobe.edu.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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