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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
B. adolescentis Bif-038 (probiotic capsule) delivered orally once daily at a minimum of 5 billion CFU/day
Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® (probiotic capsule) delivered orally once daily at a minimum of 1 billion CFU/day
Placebo capsule delivered orally once daily
Clinical Research Australia
Duncraig, Western Australia, Australia
Beck Depression Inventory-II (BDI-II) score
Change in BDI-II score after 12 weeks
Time frame: 12 weeks
Beck Anxiety Inventory (BAI) score
Change in BAI score
Time frame: 12 weeks
Depression, Anxiety, Stress Scale (DASS-21) total score
Change in DASS-21 total score
Time frame: 12 weeks
DASS-21 Stress score
Change in DASS-21 Stress score
Time frame: 12 weeks
DASS-21 Depression score
Change in DASS-21 Depression score
Time frame: 12 weeks
DASS-21 Anxiety score
Change in DASS-21 Anxiety score
Time frame: 12 weeks
Brain-derived neurotrophic factor blood concentration
Change in brain-derived neurotrophic factor blood concentration
Time frame: 12 weeks
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