Using psychobiotics to treat anxiety disorders

A Double-blind Randomized Controlled Trial Investigating Associations of Microbiota, Serum Total Antioxidant Capacity and Sleep or Psychiatric Symptoms Before and After the Intake of Psychobiotic Lactobacillus Paracasei

This study is testing if a special probiotic can help people aged 20 to 65 with anxiety feel better compared to a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: Mackay Memorial Hospital (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT05964231 on ClinicalTrials.gov

What this trial studies

This clinical trial is a double-blind randomized controlled study involving 120 participants aged 20 to 65 with generalized or unspecified anxiety disorders. Participants will be randomly assigned to receive either the psychotropic probiotic Lactobacillus paracasei PS23 or a placebo. The study will include clinical evaluations, blood sampling, and stool sample analysis to assess biochemical and inflammatory markers, as well as changes in sleep monitored by a Fitbit. The aim is to evaluate the efficacy of psychobiotics in alleviating anxiety symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 65 with a DSM-5 diagnosis of generalized anxiety disorder or unspecified anxiety disorder.

Not a fit: Patients currently taking antibiotics or those who have used probiotics recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel treatment option for patients suffering from anxiety disorders.

How similar studies have performed: Previous studies have shown promising results with psychobiotics in managing anxiety, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age 20\~70 years old
2. Patients perceived that they had anxiety-related complaints, or with any type of anxiety disorders of adjustment disorders referred from the Departments of Psychiatry, Neurology, Internal Medicine, and Family Medicine in Mackay Memorial Hospital.
3. Adult GAD-7 ≥ 8 points (to screen for generalized anxiety disorder) or a DSM-5 diagnosis of generalized anxiety disorder (F41.1) or unspecified anxiety disorder (F41.9)
4. Those who are currently under the treatment of selective serotonin reuptake inhibitors (SSRI) will only be included if their SSRI treatment has been stable or has not been changed for 4 weeks.

Exclusion Criteria:

1. Have taken antibiotics or are receiving antibiotic treatment within one month.
2. Have used probiotic products in powder, capsule or tablet form within two weeks (excluding yogurt, Yakult and other related foods).
3. Patients who have undergone hepatobiliary gastrointestinal surgery (except for colorectal polypectomy and appendectomy).
4. Past or current patients with inflammatory bowel disease.
5. Those with a history of cancer.
6. Those who are allergic to lactic acid bacteria products.
7. Patients with severe depression (Patient Health Questionnaire-9 (PHQ-9) ≧ 20 points), or possible neurocognitive impairments (Mini-Mental States Examination (MMSE)\<20), or those that had suicidal ideation noted on item 9 from PHQ-9.
8. Patients with chronic psychiatric diseases who are currently taking drugs to treat acute diseases, organic brain diseases, or newly diagnosed or changed drugs within one month.
9. Those who are receiving parenteral nutrition.
10. Those who are evaluated by the principal investigator to be unsuitable to participate in the research.

Where this trial is running

Taipei

• Mackay Memorial Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Shu-I Wu, PhD — Mackay Memorial Hospital
• Study coordinator: Shu-I Wu, PhD

Conditions Anxiety Disorders; anxiety; microbiota; psychobiotics