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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.
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 screening (Visit 1), the study design will be explained to participants, following which signed GDPR and study informed consent will be obtained. Participants will be assessed for eligibility, medical history and concomitant therapies.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B. adolescentis Bif-038 | Experimental | Probiotic capsule (single strain) |
|
| Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® | Experimental | Probiotic capsule (combination strain) |
|
| Placebo | Placebo Comparator | Placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B. adolescentis Bif-038 | Dietary Supplement | B. adolescentis Bif-038 (probiotic capsule) delivered orally once daily at a minimum of 5 billion CFU/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) score | Change in BDI-II score after 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Anxiety Inventory (BAI) score | Change in BAI score | 12 weeks |
| Depression, Anxiety, Stress Scale (DASS-21) total score | Change in DASS-21 total score |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Sleep Disturbance and Sleep-Related Impairment Scale score | Change in PROMIS Sleep Disturbance and Sleep-Related Impairment Scale score | 12 weeks |
| Tumor necrosis factor-alpha blood concentration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Lopresti, PhD | Clinical Research Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Australia | Duncraig | Western Australia | 6023 | Australia |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® | Dietary Supplement | Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® (probiotic capsule) delivered orally once daily at a minimum of 1 billion CFU/day |
|
| Placebo | Dietary Supplement | Placebo capsule delivered orally once daily |
|
| 12 weeks |
| DASS-21 Stress score | Change in DASS-21 Stress score | 12 weeks |
| DASS-21 Depression score | Change in DASS-21 Depression score | 12 weeks |
| DASS-21 Anxiety score | Change in DASS-21 Anxiety score | 12 weeks |
| Brain-derived neurotrophic factor blood concentration | Change in brain-derived neurotrophic factor blood concentration | 12 weeks |
Change in tumor necrosis factor-alpha blood concentration
| 12 weeks |
| Interleukin-6 blood concentration | Change in interleukin-6 blood concentration | 12 weeks |
| Interleukin-1beta blood concentration | Change in interleukin-1beta blood concentration | 12 weeks |
| High sensitivity C-reactive protein blood concentration | Change in high sensitivity C-reactive protein blood concentration | 12 weeks |
| Interferon-gamma blood concentration | Change in interferon-gamma blood concentration | 12 weeks |
| Lipopolysaccharide-binding protein blood concentration | Change in lipopolysaccharide-binding protein blood concentration | 12 weeks |
| Intestinal fatty acid-binding protein blood concentration | Change in intestinal fatty acid-binding protein blood concentration | 12 weeks |
| Blood cortisol concentration | Change in blood cortisol concentration | 12 weeks |
| Hair cortisol concentration | Change in hair cortisol concentration | 12 weeks |
| Heart rate variability | Change in heart rate variability via electrocardiogram (ECG) measurements | 12 weeks |
| Fecal microbial profile | Change in fecal microbial profile via shotgun metagenomic sequencing | 12 weeks |