Status:
COMPLETED
The Intervention of Psychobiotics in Patients With Anxiety Disorders
Lead Sponsor:
Mackay Memorial Hospital
Conditions:
Anxiety Disorders
Eligibility:
All Genders
20-70 years
Phase:
NA
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. Afte...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT05964231
Start Date
August 1 2023
End Date
July 31 2025
Last Update
December 5 2025
Active Locations (1)
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1
Mackay Memorial Hospital
Taipei, Taiwan, 10448