Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms

NCT05564767 | Completed

• 1 other identifier: HND-MH-051
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory-II (BDI-II) score

  Change in BDI-II score after 12 weeks

  12 weeks

Secondary Outcomes (6)

• Beck Anxiety Inventory (BAI) score

  12 weeks

• Depression, Anxiety, Stress Scale (DASS-21) total score

  12 weeks

• DASS-21 Stress score

  12 weeks

• DASS-21 Depression score

  12 weeks

• DASS-21 Anxiety score

  12 weeks

Other Outcomes (12)

• PROMIS Sleep Disturbance and Sleep-Related Impairment Scale score

  12 weeks

• Tumor necrosis factor-alpha blood concentration

  12 weeks

• Interleukin-6 blood concentration

  12 weeks

Study Arms (3)

B. adolescentis Bif-038

EXPERIMENTAL

Probiotic capsule (single strain)

Dietary Supplement: B. adolescentis Bif-038

Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®

EXPERIMENTAL

Probiotic capsule (combination strain)

Dietary Supplement: Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®

Placebo

PLACEBO COMPARATOR

Placebo capsule

Dietary Supplement: Placebo

Interventions

B. adolescentis Bif-038 DIETARY_SUPPLEMENT

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

B. adolescentis Bif-038

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

Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®

Placebo DIETARY_SUPPLEMENT

Placebo capsule delivered orally once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy adults (male and female) 18 to 65 years
• 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
• Body mass index (BMI) between 18.5 and 30.0 kg/m2
• Non-smoker
• No plan to change dietary or exercise habits during the study period
• No recent history (within 3 months) or plan to commence new treatments over the study period
• Willing and able to take probiotic/placebo regimen for 12 weeks
• Understand, willing and able to comply with all study procedures
• Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.

You may not qualify if:

• 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
• 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)
• Regular medication intake, including but not limited to anticholinergics, anti-epileptics, acetylcholinesterase inhibitors, benzodiazepines, antipsychotics, opioids, or corticosteroids.
• Within 2 months before screening, the use of pharmaceutical medications, including but not limited to immunosuppressant drugs, antibiotics, and steroids
• 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,
• Use of probiotics or mood support supplement up to 4 weeks before study commencement
• Current or 12-month history of illicit drug abuse
• Alcohol intake greater than 14 standard drinks per week
• Any significant surgeries over the last year
• Women who are pregnant, breastfeeding or intend to fall pregnant

Sponsors & Collaborators

• Chr Hansen: lead

Study Sites (1)

Clinical Research Australia

Duncraig, Western Australia, 6023, Australia

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Adrian Lopresti, PhD

  Clinical Research Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 4, 2022
• Study Start: October 17, 2022
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

AU (1)