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

NCT ID: NCT05564767

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2023-03-20

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.

Detailed Description

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.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

B. adolescentis Bif-038

Probiotic capsule (single strain)

Group Type: EXPERIMENTAL

B. adolescentis Bif-038

Intervention Type: DIETARY_SUPPLEMENT

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 (combination strain)

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Placebo capsule

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsule delivered orally once daily

Interventions

B. adolescentis Bif-038

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo capsule delivered orally once daily

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chr Hansen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Lopresti, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Australia

Locations

Clinical Research Australia

Duncraig, Western Australia, Australia

Countries

Australia

Other Identifiers

HND-MH-051

Identifier Type: -

Identifier Source: org_study_id