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The Intervention of Psychobiotics in Patients With Anxiety Disorders

NCT05964231 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-12-05

No results posted yet for this study

Summary

The investigators designed this double blind randomized controlled study and will recruit 120 patients 20 to 65 years old, with DSM-5 generalized anxiety disorder or unspecified anxiety disorder. After clinical symptoms and psychological evaluation and blood sampling, a semi-structural interview delivered by a psychiatrist will be established to confirm the DSM-5 diagnosis. The participants will be randomly assigned to the Lactobacillus paracasei PS23 psychotropic probiotic or placebo group. Blood and stool samples will be obtained after consent. The samples will be tested for biochemistry, inflammation index, cytokines, intestinal osmotic pressure, or gut permeability, and a Fitbit fitness watch will be given to measure changes in sleep.

Conditions

  • Anxiety Disorders

Interventions

DIETARY_SUPPLEMENT

Heat-treated PS23

Lactobacillus paracasei PS23 heat-treated, 2caps daily use

DIETARY_SUPPLEMENT

Placebo

microcrystalline cellulose, 2caps daily use

Sponsors & Collaborators

  • Mackay Memorial Hospital

    lead OTHER

Principal Investigators

  • Shu-I Wu, PhD · Mackay Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05964231 on ClinicalTrials.gov