The Intervention of Psychobiotics in Patients With Anxiety Disorders

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study aimed to recruit 120 subjects that meet the following inclusion criteria after the approval of the IRB. Those agreed to participate and signed the informed consent will be randomly divided into two groups of the Lactobacillus paracasei PS23 psychobiotics capsule and the placebo. Each group aims to recruit 60 people. The power analysis was conducted using effect size for outcomes of improvements in anxiety from previous studies. Based on a power of 80% and assuming a 30% dropout rate and an alpha level of 0.05, a sample of 120 participants (60 per group) will be required. All results will be analyzed using an intent-to-treat analysis based on treatment assignment, regardless of completion or not. ;

Study Design

Related Conditions & MeSH terms

Anxiety Disorders

Clinical Trial Details

NCT number	NCT05964231
Study type	Interventional
Source	Mackay Memorial Hospital
Contact	Shu-I Wu, PhD
Phone	+886-975835215
Email	shuiwu624@gmail.com
Status	Recruiting
Phase	N/A
Start date	August 1, 2023
Completion date	July 31, 2024

View Details

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