Probiotic for Depression

(PAD Trial)

Overseen By Cherry Leung, PhD, RN

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, San Francisco

Must be taking: SSRIs

Must not be taking: Antibiotics, Probiotics, Antioxidants, Omega 3

Disqualifiers: Other mental disorders, Personality disorders, Immunocompromised, others

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

77 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to be on a stable dose of SSRI medication for at least 8 weeks, so you will not need to stop taking your SSRI. However, if you are on stimulant medication for ADHD, you must be on a stable dosage with no plans to change it for at least 8 weeks.

What data supports the effectiveness of the treatment Visbiome for depression?

Research shows that probiotics, like those in Visbiome, can help reduce symptoms of depression by improving gut health and brain function. Studies found that probiotics increased beneficial gut bacteria and were linked to decreased depressive symptoms, suggesting they may be a helpful addition to traditional depression treatments. ^{1 2 3 4 5}

Is the probiotic treatment safe for humans?

Research indicates that probiotics, including those containing Lactobacillus and Bifidobacterium strains, are generally safe and well-tolerated in humans, with few and mild side effects reported in studies involving patients with depression. ^{2 4 6 7 8}

How is the treatment Visbiome unique for depression?

Visbiome is unique for depression because it targets the microbiota-gut-brain (MGB) axis, which is a novel approach compared to traditional antidepressants. It uses probiotics to alter gut bacteria, potentially reducing depressive symptoms by normalizing stress-related brain activity. ^{1 3 9 10 11}

What is the purpose of this trial?

This double-blind, placebo-controlled clinical trial will examine the effect of probiotic Visbiome on the brain and gut microbiome of individuals 15 to 24 years of age.

Research Team

Cherry Leung, PhD, RN

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for young people aged 15-24 who are experiencing depression. Participants must meet specific criteria to join, but these details aren't provided here.

Inclusion Criteria

Participants must be under the care of a primary care clinician and/or mental health professional

BDI-II score greater than 13

Access to smartphone, tablet, or computer, on which program 'Zoom' can be run for remote visits

Exclusion Criteria

Current alcohol intake greater than 2 drinks per week

Any plans to make significant change in diet and lifestyle

Allergies to milk, soy, or yeast

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive Visbiome or placebo for 8 weeks to assess effects on neural connectivity and gut microbiome

8 weeks

4 visits (in-person or virtual every 2 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Visbiome

Trial Overview The study tests the effects of a probiotic called Visbiome versus a placebo on brain function and gut health in adolescents with depression. It's double-blind, meaning neither participants nor researchers know who gets the real treatment.

Participant Groups

Group I: Probiotic Active Control 1 Intervention

Visbiome 450 billion CFU (sachet) twice daily

Group II: Placebo twice daily Placebo Group 1 Intervention

Placebo (maltose sachet) twice daily

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical, gut microbial and neural effects of a probiotic add-on therapy in depressed patients: a randomized controlled trial. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Gut Microbiome in Depression and Potential Benefit of Prebiotics, Probiotics and Synbiotics: A Systematic Review of Clinical Trials and Observational Studies. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Probiotics on Symptoms of Depression: Protocol for a Double-Blind Randomized Placebo-Controlled Trial. [2020]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

Probiotics and the microbiota-gut-brain axis: focus on patients with depression. A review of current research. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

[Depressive Disorder and Gut-brain Interaction]. [2017]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy, Safety, and Tolerability of Probiotics on Depression: Clinical Results From an Open-Label Pilot Study. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A combination of probiotics and magnesium orotate attenuate depression in a small SSRI resistant cohort: an intestinal anti-inflammatory response is suggested. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Possible association of Bifidobacterium and Lactobacillus in the gut microbiota of patients with major depressive disorder. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The gut microbiota, HPA axis, and brain in adolescent-onset depression: Probiotics as a novel treatment. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Neuropsychiatric Disorders: Influence of Gut Microbe to Brain Signalling. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The Putative Antidepressant Mechanisms of Probiotic Bacteria: Relevant Genes and Proteins. [2021]