The Intervention of Psychobiotics in Patients With Anxiety Disorders

Last updated: August 13, 2024
Sponsor: Mackay Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Panic Disorders

Mood Disorders

Treatment

Placebo

Heat-treated PS23

Clinical Study ID

NCT05964231
112-2314-B-195-008-
  • Ages 20-70
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 20~70 years old

  2. Patients perceived that they had anxiety-related complaints, or with any type ofanxiety disorders of adjustment disorders referred from the Departments ofPsychiatry, Neurology, Internal Medicine, and Family Medicine in Mackay MemorialHospital.

  3. Adult GAD-7 ≥ 8 points (to screen for generalized anxiety disorder) or a DSM-5diagnosis of generalized anxiety disorder (F41.1) or unspecified anxiety disorder (F41.9)

  4. Those who are currently under the treatment of selective serotonin reuptakeinhibitors (SSRI) will only be included if their SSRI treatment has been stable orhas not been changed for 4 weeks.

Exclusion

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 forcolorectal 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) ≧ 20points), 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 treatacute diseases, organic brain diseases, or newly diagnosed or changed drugs withinone month.

  9. Those who are receiving parenteral nutrition.

  10. Those who are evaluated by the principal investigator to be unsuitable toparticipate in the research.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Mackay Memorial Hospital

    Taipei, 10448
    Taiwan

    Active - Recruiting

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