Probiotic for Depression
(PAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the probiotic Visbiome can improve symptoms of depression by affecting brain and gut health. Participants will receive either the Visbiome probiotic or a placebo to compare effects. Ideal candidates are aged 15 to 24, diagnosed with depression, and have been on an SSRI (a common type of antidepressant) for at least eight weeks. As an Early Phase 1 trial, this research focuses on understanding how Visbiome works in people, offering participants a chance to contribute to groundbreaking insights.
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.
Is there any evidence suggesting that Visbiome is likely to be safe for humans?
Research has shown that Visbiome, a strong probiotic, is generally safe for people. In a small study with 49 participants, those who took Visbiome daily for eight weeks experienced fewer symptoms of depression and tolerated it well. No major side effects were reported, indicating that Visbiome is safe to use. Other studies have also found that people taking Visbiome experienced less depression over time without serious side effects. While this is promising, it is important to remember that this is early research, and more studies are needed to confirm these results.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for depression, which often involve antidepressants like SSRIs or therapy, Visbiome is a probiotic that introduces beneficial bacteria to the gut. Researchers are excited about Visbiome because it offers a novel approach by targeting the gut-brain axis, which is a new mechanism of action for treating depression. This could potentially lead to fewer side effects compared to traditional medications and offer a more natural alternative for managing mental health.
What evidence suggests that Visbiome might be an effective treatment for depression?
Research has shown that Visbiome, a potent probiotic, might help reduce depression symptoms. People taking Visbiome report feeling less depressed over time. One study found that participants with major depressive disorder felt better after taking probiotics for eight weeks. In this trial, participants will receive either Visbiome or a placebo to evaluate its effects on depression symptoms. The probiotic's benefits likely stem from its effects on the gut and brain, which may influence mood. Overall, early research suggests that Visbiome could be a promising option for easing depression symptoms.46789
Who Is on the Research Team?
Cherry Leung, PhD, RN
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Visbiome or placebo for 8 weeks to assess effects on neural connectivity and gut microbiome
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Visbiome
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator