The Intervention of Psychobiotics in Patients With Anxiety Disorders

NCT05964231 | Completed

• 1 other identifier: 112-2314-B-195-008-
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

anxiety; microbiota; psychobiotics

Outcome Measures

Primary Outcomes (1)

• Changes from the HAM-A compared to placebo.

  Hamilton Anxiety Scale(HAM-A) score changes downwards ≥ 20% indicate significant improvement.

  change from baseline score at 8 weeks

Secondary Outcomes (12)

• Differences in the Generalized Anxiety Disorder 7-item (GAD-7) compared to placebo.

  change from baseline score at 8 weeks

• Differences in the State and Trait Anxiety Index (STAI) compared to placebo.

  change from baseline score at 8 weeks

• Differences in Insomnia Severity index (ISI) compared to placebo.

  change from baseline score at 8 weeks

• Differences in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) compared to placebo.

  change from baseline score at 8 weeks

• Differences in the The Profile of Mood States (POMS) compared to placebo.

  change from baseline score at 8 weeks

Study Arms (2)

Heat-treated PS23

EXPERIMENTAL

Lactobacillus paracasei PS23 heat-treated

Dietary Supplement: Heat-treated PS23

Placebo

PLACEBO COMPARATOR

microcrystalline cellulose

Dietary Supplement: Placebo

Interventions

Heat-treated PS23 DIETARY_SUPPLEMENT

Lactobacillus paracasei PS23 heat-treated, 2caps daily use

Heat-treated PS23

Placebo DIETARY_SUPPLEMENT

microcrystalline cellulose, 2caps daily use

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20\~70 years old
• 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.
• 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)
• 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.

You may not qualify if:

• Have taken antibiotics or are receiving antibiotic treatment within one month.
• Have used probiotic products in powder, capsule or tablet form within two weeks (excluding yogurt, Yakult and other related foods).
• Patients who have undergone hepatobiliary gastrointestinal surgery (except for colorectal polypectomy and appendectomy).
• Past or current patients with inflammatory bowel disease.
• Those with a history of cancer.
• Those who are allergic to lactic acid bacteria products.
• 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.
• 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.
• Those who are receiving parenteral nutrition.
• Those who are evaluated by the principal investigator to be unsuitable to participate in the research.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay Memorial Hospital

Taipei, 10448, Taiwan

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Shu-I Wu, PhD

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Attending Psychiatrist, associate professor

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 27, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

TW (1)