Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964231
Status:
RECRUITING
Last Update Posted:
2023-08-29
First Post:
2023-07-17
Brief Title:
The Intervention of Psychobiotics in Patients With Anxiety Disorders
Sponsor:
Mackay Memorial Hospital
Organization:
Mackay Memorial Hospital
Study Overview
Official Title:
A Double-blind Randomized Controlled Trial Investigating Associations of Microbiota Serum Total Antioxidant Capacity and Sleep or Psychiatric Symptoms Before and After the Intake of Psychobiotic Lactobacillus Paracasei
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 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 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None