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

Depression, Anxiety Clinical Trial

Official title:

Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms: A Pilot Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05564767
• Other study ID #: HND-MH-051
• Status: Completed
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: March 20, 2023

Study information

• Verified date: August 2023
• Source: Chr Hansen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety

Intervention

Dietary Supplement:
• B. adolescentis Bif-038
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®
Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® (probiotic capsule) delivered orally once daily at a minimum of 1 billion CFU/day
• Placebo
Placebo capsule delivered orally once daily

Locations

Country	Name	City	State
Australia	Clinical Research Australia	Duncraig	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Chr Hansen

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PROMIS Sleep Disturbance and Sleep-Related Impairment Scale score	Change in PROMIS Sleep Disturbance and Sleep-Related Impairment Scale score	12 weeks
Other	Tumor necrosis factor-alpha blood concentration	Change in tumor necrosis factor-alpha blood concentration	12 weeks
Other	Interleukin-6 blood concentration	Change in interleukin-6 blood concentration	12 weeks
Other	Interleukin-1beta blood concentration	Change in interleukin-1beta blood concentration	12 weeks
Other	High sensitivity C-reactive protein blood concentration	Change in high sensitivity C-reactive protein blood concentration	12 weeks
Other	Interferon-gamma blood concentration	Change in interferon-gamma blood concentration	12 weeks
Other	Lipopolysaccharide-binding protein blood concentration	Change in lipopolysaccharide-binding protein blood concentration	12 weeks
Other	Intestinal fatty acid-binding protein blood concentration	Change in intestinal fatty acid-binding protein blood concentration	12 weeks
Other	Blood cortisol concentration	Change in blood cortisol concentration	12 weeks
Other	Hair cortisol concentration	Change in hair cortisol concentration	12 weeks
Other	Heart rate variability	Change in heart rate variability via electrocardiogram (ECG) measurements	12 weeks
Other	Fecal microbial profile	Change in fecal microbial profile via shotgun metagenomic sequencing	12 weeks
Primary	Beck Depression Inventory-II (BDI-II) score	Change in BDI-II score after 12 weeks	12 weeks
Secondary	Beck Anxiety Inventory (BAI) score	Change in BAI score	12 weeks
Secondary	Depression, Anxiety, Stress Scale (DASS-21) total score	Change in DASS-21 total score	12 weeks
Secondary	DASS-21 Stress score	Change in DASS-21 Stress score	12 weeks
Secondary	DASS-21 Depression score	Change in DASS-21 Depression score	12 weeks
Secondary	DASS-21 Anxiety score	Change in DASS-21 Anxiety score	12 weeks
Secondary	Brain-derived neurotrophic factor blood concentration	Change in brain-derived neurotrophic factor blood concentration	12 weeks