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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05564767




Registration number
NCT05564767
Ethics application status
Date submitted
29/09/2022
Date registered
4/10/2022
Date last updated
21/08/2023

Titles & IDs
Public title
Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms
Scientific title
Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms: A Pilot Randomized Placebo-controlled Trial
Secondary ID [1] 0 0
HND-MH-051
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression, Anxiety 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - B. adolescentis Bif-038
Other interventions - Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®
Other interventions - Placebo

Experimental: B. adolescentis Bif-038 - Probiotic capsule (single strain)

Experimental: Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® - Probiotic capsule (combination strain)

Placebo Comparator: Placebo - Placebo capsule


Other interventions: B. adolescentis Bif-038
B. adolescentis Bif-038 (probiotic capsule) delivered orally once daily at a minimum of 5 billion CFU/day

Other interventions: Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®
Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® (probiotic capsule) delivered orally once daily at a minimum of 1 billion CFU/day

Other interventions: Placebo
Placebo capsule delivered orally once daily
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Beck Depression Inventory-II (BDI-II) score
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Beck Anxiety Inventory (BAI) score
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Depression, Anxiety, Stress Scale (DASS-21) total score
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
DASS-21 Stress score
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
DASS-21 Depression score
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
DASS-21 Anxiety score
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Brain-derived neurotrophic factor blood concentration
Timepoint [6] 0 0
12 weeks

Eligibility
Key inclusion criteria
1. Generally healthy adults (male and female) 18 to 65 years

2. Currently experiencing 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/03/2023
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Clinical Research Australia - Duncraig
Recruitment postcode(s) [1] 0 0
6023 - Duncraig

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Chr Hansen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a 3-arm, parallel-group, randomized, double-blind, placebo-controlled pilot trial.
Sixty adults presenting with depressive symptoms will be randomly allocated to one of 3
groups comprising (1) Bifidobacterium adolescentis or (2) Lactocaseibacillus rhamnosus LGG
and Bifidobacterium BB-12 or (3) a placebo for 12 weeks.

At baseline (Visit 2), midpoint (Visit 3) and end-of-study (Visit 4) visits, participants
meeting eligibility criteria will complete the BDI-II, BAI, DASS-21 and PROMIS Sleep
questionnaires and blood samples will be collected for biomarker assessments. Fecal samples
will be collected prior to the baseline and end-of-study visits for microbial profiling.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05564767
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Adrian Lopresti, PhD
Address 0 0
Clinical Research Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries