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Trial registered on ANZCTR
Registration number
ACTRN12622001078741
Ethics application status
Approved
Date submitted
2/08/2022
Date registered
4/08/2022
Date last updated
19/01/2024
Date data sharing statement initially provided
4/08/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of two probiotic formulations on mental health and mood biomarkers in adults with depressive symptoms
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Scientific title
Effect of two probiotic formulations on mental health and mood biomarkers in adults with depressive symptoms: A pilot randomized placebo-controlled trial.
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Secondary ID [1]
307684
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None
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Universal Trial Number (UTN)
U1111-1281-0892
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
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Anxiety
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Insomnia
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Condition category
Condition code
Mental Health
324361
324361
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0
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Depression
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Mental Health
324362
324362
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0
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Anxiety
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Alternative and Complementary Medicine
324363
324363
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0
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Other alternative and complementary medicine
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Inflammatory and Immune System
324364
324364
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0
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Other inflammatory or immune system disorders
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Neurological
324399
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Probiotic capsules containing Bifidobacterium adolescentis (1 capsule taken orally, once daily in the morning, delivering 5 billion colony-forming units a day for 12 weeks) or Probiotic capsules containing Lacticaseibacillus rhamnosus LGG and Bifidobacterium BB-12 (1 capsule taken orally, once daily in the morning, delivering 1 billion colony-forming units a day for 12 weeks). Adherence to capsule intake will be measured by capsule return at weeks 6 and 12.
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Intervention code [1]
324160
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Treatment: Other
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Comparator / control treatment
Placebo (containing maltodextrin and microcrystalline cellulose) is matched to the probiotic capsules in terms of taste and appearance but does not contain any of the active ingredients.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Change in Beck Depression Inventory-II score
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Assessment method [1]
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Timepoint [1]
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Day 0, week 6, and 12 (primary endpoint) post-intervention commencement
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Secondary outcome [1]
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Change in Beck Anxiety Inventory score
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Assessment method [1]
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Timepoint [1]
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [2]
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Change in Depression, Anxiety, and Stress Scale - 21 score
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Assessment method [2]
412426
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Timepoint [2]
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [3]
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Change in PROMIS Sleep Disturbance and Sleep-Related Impairment Scale score
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Assessment method [3]
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Timepoint [3]
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [4]
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Change in Brain-derived neurotrophic factor blood concentration
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Assessment method [4]
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Timepoint [4]
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [5]
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Change in tumor necrosis factor-alpha blood concentration
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Assessment method [5]
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Timepoint [5]
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [6]
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Change in interleukin-6 blood concentration
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Assessment method [6]
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Timepoint [6]
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [7]
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Change in interleukin-1beta blood concentration
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Assessment method [7]
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Timepoint [7]
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [8]
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Change in high sensitivity C-reactive protein blood concentration
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Assessment method [8]
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Timepoint [8]
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [9]
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Change in interferon-gamma blood concentration
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Assessment method [9]
412433
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Timepoint [9]
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [10]
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Change in lipopolysaccharide-binding protein blood concentration
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Assessment method [10]
412434
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Timepoint [10]
412434
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [11]
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Change in intestinal fatty acid-binding protein blood concentration
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Assessment method [11]
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Timepoint [11]
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [12]
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Change in blood cortisol concentration
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Assessment method [12]
412436
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Timepoint [12]
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [13]
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Change in hair cortisol concentration
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Assessment method [13]
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Timepoint [13]
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Day 0 and week 12 post-intervention commencement
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Secondary outcome [14]
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Change in heart rate variability as measured by electrocardiogram (ECG) measurements using a heart rate monitor strap
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Assessment method [14]
412438
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Timepoint [14]
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Day 0, week 6, and 12 post-intervention commencement
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Secondary outcome [15]
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Change in microbial stool profile as measured by a stool sample collection using shotgun metagenomic sequencing
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Assessment method [15]
412439
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Timepoint [15]
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Day 0 and week 12 post-intervention commencement
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Eligibility
Key inclusion criteria
1. Generally healthy adults (male and female) 18 to 65 years
2. Currently experience mild to moderate depressive symptoms as indicated by a score of between 20 and 40 on the BDI-II at both the screening and baseline visit
3. Body mass index (BMI) between 18.5 and 30.0 kg/m2
4. Non-smoker
5. No plan to change dietary or exercise habits during the study period
6. No recent history (within 3 months) or plan to commence new treatments over the study period
7. Willing and able to take probiotic/placebo regimen for 12 weeks
8. Understand, willing and able to comply with all study procedures
9. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease, autoimmune disease, endocrine disease, acute or chronic pain condition, or cancer/malignancy
2. Diagnosis of psychiatric or neurological conditions including but not limited to: psychiatric disorders other than mild-to-moderate depression and/or anxiety disorder, or neurological disease (e.g., Parkinson’s, Alzheimer’s disease, intracranial hemorrhage, head or brain injury)
3. Regular medication intake, including but not limited to anticholinergics, anti-epileptics, acetylcholinesterase inhibitors, benzodiazepines, antipsychotics, opioids, or corticosteroids.
4. Within 2 months before screening, the use of pharmaceutical medications, including but not limited to immunosuppressant drugs, antibiotics, and steroids
5. Change in medication (dose or type) in the last 3 months or an expectation to change during the study duration. Permitted medications include, but are not limited to, pharmaceutical antidepressants such as selective serotonin reuptake inhibitors (SSRIs), and serotonin and norepinephrine reuptake inhibitors (SNRIs), cholesterol-lowering medications, antihypertensives, proton pump inhibitors, and thyroid medications,
6. Use of probiotics or mood support supplement up to 4 weeks before study commencement
7. Current or 12-month history of illicit drug abuse
8. Alcohol intake greater than 14 standard drinks per week
9. Any significant surgeries over the last year
10. Women who are pregnant, breastfeeding or intend to fall pregnant
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed through the use of numbered containers
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by computer software
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
For this pilot study, a convenience sample size of 60 adults is planned for recruitment. No sample size calculation has been completed.
Primary end point will be change in BDI-II score from weeks 0 to 12 and analysed using Generalized Linear Mixed Models (GLMM) with treatment (active combined vs placebo) as factor and adjusted for baseline value of BDI-II.
The parametric statistical analysis model is check using QQ residual plots together with Kolmogorov-Smirnov test for normality.
If test for normality for residuals is not passed, values will be log transferred.
If test for normality is not passed when log-transformation is performed, non-parametric statistical analysis will be used (Mann-Whitney test). The non-parametric analysis will be unadjusted.
Comparison between the three individually treatments groups will be performed as exploratory analysis.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
3/10/2022
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Actual
12/10/2022
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Date of last participant enrolment
Anticipated
23/01/2023
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Actual
23/12/2022
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Date of last data collection
Anticipated
3/04/2023
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Actual
20/03/2023
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Sample size
Target
60
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Accrual to date
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Final
62
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Chr. Hansen
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Address [1]
311955
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Kogle Allé 6, DK-2970 Hørsholm, Denmark
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Country [1]
311955
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Denmark
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Primary sponsor type
Commercial sector/Industry
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Name
Clinical Research Australia
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Address
38 Arnisdale Rd Duncraig WA 6023
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
313440
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Country [1]
313440
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
311386
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National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
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Ethics committee address [1]
311386
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11-23 Burwood Rd Hawthorn VIC 3122
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Ethics committee country [1]
311386
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Australia
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Date submitted for ethics approval [1]
311386
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12/07/2022
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Approval date [1]
311386
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06/09/2022
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Ethics approval number [1]
311386
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0107E_2022
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Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 60 adults presenting with depressive symptoms will be randomly assigned to receive probiotic capsules containing (1) Bifidobacterium adolescentis (5 billion colony-forming units a day), or (2) Lacticaseibacillus rhamnosus LGG and Bifidobacterium BB-12 (1 billion colony-forming units a day), or (3) a placebo for 12 weeks. We will assess changes in mood and sleep using self-report questionnaires. Changes in blood markers associated with inflammation (tumour necrosis factor-alpha, interleukin -1beta, interleukin-6, interferon-gamma, and high-sensitivity C-reactive protein), intestinal barrier integrity (lipopolysaccharide-binding protein and intestinal fatty acid-binding protein), and brain-derived neurotrophic factor (important for the survival of brain cells) will be assessed over time. We will also assess changes in cortisol (blood and hair), heart rate variability, and the gut microbiome over time.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Adrian Lopresti
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Address
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
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Australia
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Phone
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+61 08 94487376
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Adrian Lopresti
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Address
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
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Australia
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Phone
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+61 08 94487376
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Adrian Lopresti
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Address
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
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Australia
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Phone
120912
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+61 08 94487376
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data underlying published results
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
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Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
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Available for what types of analyses?
for IPD meta-analyses
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How or where can data be obtained?
Access subject to approvals by Principal Investigator (
[email protected]
)
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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