Mackay Memorial Hospital
Taipei, 10448, Taiwan
NCT Number: NCT05964231
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.
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Notify Me20 year–70 year
All sexes
Interventional
Not applicable
Taipei, 10448, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lactobacillus paracasei PS23 heat-treated, 2caps daily use
microcrystalline cellulose, 2caps daily use
Time frame: change from baseline score at 8 weeks
Hamilton Anxiety Scale(HAM-A) score changes downwards ≥ 20% indicate significant improvement.
Time frame: change from baseline score at 8 weeks
The GAD-7 is a easy to perform initial screening tool for generalized anxiety disorder, When screening for anxiety disorders, a score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder;Using a cut-off of 8 the GAD-7 has a sensitivity of 92% and specificity of 76% for diagnosis generalized anxiety disorder.
Time frame: change from baseline score at 8 weeks
The STAI measures levels of anxiety in the current 'state' or from the 'trait'. Good reliability (0.86~0.95) and sensitivity (0.85) were found and the higher the scores, the severe the levels of anxiety.
Time frame: change from baseline score at 8 weeks
The ISI is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.
Time frame: change from baseline score at 8 weeks
The QLESQ-16 is a valid, reliable self-report instrument for assessing quality of life.
Time frame: change from baseline score at 8 weeks
The POMS is a psychological rating scale used to assess transient, distinct mood states.
Time frame: change from baseline score at 8 weeks
VAS consists of a line, 10 cm in length. Individuals point to or mark a spot on the line where they feel indicates their current their emotion, fatigue level and sleep quality. The score of emotion level is from 0cm (very nervous) to 10 cm (very relaxing). The score of fatigue level is from 0 cm (very energetic) to 10 cm (very sleepy). The score of sleep quality is from 0 cm (poor) to 10 cm (sleep well). The maximum total score is 100% (equal 10cm).
Time frame: change from baseline score at 8 weeks
TAC is the biomarker for Oxidative stress.
Time frame: change from baseline score at 8 weeks
DHEA-S is the biomarker for anti-aging,among the neuroactive steroids, dehydroepiandrosterone (3b-hydroxyandrost-5-ene-17-one, [DHEA]) and its sulfated metabolite DHEA sulfate (DHEAS) have been shown to be potent modulators of neural function, including neurogenesis, neuronal growth and differentiation, and neuroprotection. Highlighting the potential health significance of DHEA and DHEAS in humans, serum concentrations decrease steadily with age, with lowest concentrations present at the time many diseases of aging and neurodegeneration become apparent.
Time frame: change from baseline score at 8 weeks
Cortisol is a steroid hormone that is produced by the adrenal glands which sit on top of each kidney. When released into the bloodstream, cortisol can act on many different parts of the body and can help: body respond to stress or danger increase your body's metabolism of glucose control your blood pressure reduce inflammation. Cortisol is also needed for the fight or flight response which is a healthy, natural response to perceived threats. The amount of cortisol produced is highly regulated by your body to ensure the balance is correct.
Time frame: change from baseline score at 8 weeks
High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation that predicts incident myocardial infarction, stroke, peripheral arterial disease, and sudden cardiac death among healthy individuals with no history of cardiovascular disease, and recurrent events and death in patients with acute or stable coronary syndromes.
Time frame: change from baseline score at 8 weeks
Analyses on inflammatory and anxiety measures cytokines including IL-2, IL-6, IL-10, IL-1beta, TNF-alpha, and BDNF will be performed by ELISA tool following the suppliers' protocol (eBioscience, Boston, MA).
Time frame: change from baseline score at 8 weeks
The composition of the gut microbiome from stool sample will be examined by Illumina MiSeq Platform. Fecal sample will be washed and prepared with sterile PBS. All samples will be prepared according to the manufacturer's guidelines. Fecal DNA on the V3-V4 regions will be amplified by16s amplicon PCR primers. An online bioinformatics database will be used for the identifications of bacteria and quality filtering.
Mackay Memorial Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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