Anxiety DisordersNCT05964231
The Intervention of Psychobiotics in Patients With Anxiety Disorders
A study testing Heat-treated PS23 in people with Anxiety Disorders, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Heat-treated PS23
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 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.
- Conditions
- Anxiety Disorders
- Being tested
- Heat-treated PS23, Placebo
- Keywords
- anxiety, microbiota, psychobiotics
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat-treated PS23Dietary supplement
Lactobacillus paracasei PS23 heat-treated, 2caps daily use
PlaceboDietary supplement
microcrystalline cellulose, 2caps daily use
| Study group | Role | What they receive |
|---|---|---|
| Heat-treated PS23 | Experimental | Lactobacillus paracasei PS23 heat-treated Receives: Dietary Supplement: Heat-treated PS23 |
| Placebo | Placebo comparator | microcrystalline cellulose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from the HAM-A compared to placebo.
Hamilton Anxiety Scale(HAM-A) score changes downwards ≥ 20% indicate significant improvement.
Measured: change from baseline score at 8 weeks
Secondary outcomes (12)
Differences in the Generalized Anxiety Disorder 7-item (GAD-7) compared to placebo.
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.
Measured: change from baseline score at 8 weeks
Differences in the State and Trait Anxiety Index (STAI) compared to placebo.
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.
Measured: change from baseline score at 8 weeks
Differences in Insomnia Severity index (ISI) compared to placebo.
The ISI is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.
Measured: change from baseline score at 8 weeks
Differences in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) compared to placebo.
The QLESQ-16 is a valid, reliable self-report instrument for assessing quality of life.
Measured: change from baseline score at 8 weeks
Differences in the The Profile of Mood States (POMS) compared to placebo.
The POMS is a psychological rating scale used to assess transient, distinct mood states.
Measured: change from baseline score at 8 weeks
Differences in Visual Analogue Scale-GI (VAS-GI) compared to placebo.
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).
Measured: change from baseline score at 8 weeks
Changes in blood TAC (Total Antioxidant Capacity) before and after consumption of probiotics
TAC is the biomarker for Oxidative stress.
Measured: change from baseline score at 8 weeks
Changes in blood DHEA-S (Dehydroepiandrosterone sulfate) compared to placebo.
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.
Measured: change from baseline score at 8 weeks
Changes in blood Cortisol compared to placebo.
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.
Measured: change from baseline score at 8 weeks
Changes in blood High sensitivity CRP (hs CRP) compared to placebo.
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.
Measured: change from baseline score at 8 weeks
Improvements and differences compared to placebo on oxidative, inflammation, and stress biomarkers.
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).
Measured: change from baseline score at 8 weeks
Changes zonulin and calprotectin in fecal sample compared to placebo.
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.
Measured: change from baseline score at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-I Wu, Mackay Memorial Hospital
- Investigators
- Shu-I Wu, PhD, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964231
- Sponsor's protocol ID
- 112-2314-B-195-008-
- Status last verified
- Nov 2025
- First submitted
- 17 Jul 2023
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05964231
- Acronym / sponsor ID
- 112-2314-B-195-008-
- Conditions
- Anxiety Disorders
- Keywords
- anxiety, microbiota, psychobiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat-treated PS23 | Experimental | Dietary Supplement: Heat-treated PS23Lactobacillus paracasei PS23 heat-treated |
| Placebo | Placebo comparator | Dietary Supplement: Placebomicrocrystalline cellulose |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat-treated PS23Lactobacillus paracasei PS23 heat-treated, 2caps daily use | Dietary supplement | Heat-treated PS23 |
| Placebomicrocrystalline cellulose, 2caps daily use | Dietary supplement | Placebo |
Primary outcome
Changes from the HAM-A compared to placebo.
Time frame: change from baseline score at 8 weeks
Hamilton Anxiety Scale(HAM-A) score changes downwards ≥ 20% indicate significant improvement.
12 secondary outcomes
Differences in the Generalized Anxiety Disorder 7-item (GAD-7) compared to placebo.
Time frame: change from baseline score at 8 weeks
Differences in the State and Trait Anxiety Index (STAI) compared to placebo.
Time frame: change from baseline score at 8 weeks
Differences in Insomnia Severity index (ISI) compared to placebo.
Time frame: change from baseline score at 8 weeks
Differences in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) compared to placebo.
Time frame: change from baseline score at 8 weeks
Differences in the The Profile of Mood States (POMS) compared to placebo.
Time frame: change from baseline score at 8 weeks
Differences in Visual Analogue Scale-GI (VAS-GI) compared to placebo.
Time frame: change from baseline score at 8 weeks
Changes in blood TAC (Total Antioxidant Capacity) before and after consumption of probiotics
Time frame: change from baseline score at 8 weeks
Changes in blood DHEA-S (Dehydroepiandrosterone sulfate) compared to placebo.
Time frame: change from baseline score at 8 weeks
Changes in blood Cortisol compared to placebo.
Time frame: change from baseline score at 8 weeks
Changes in blood High sensitivity CRP (hs CRP) compared to placebo.
Time frame: change from baseline score at 8 weeks
Improvements and differences compared to placebo on oxidative, inflammation, and stress biomarkers.
Time frame: change from baseline score at 8 weeks
Changes zonulin and calprotectin in fecal sample compared to placebo.
Time frame: change from baseline score at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-I Wu, PhD principal investigator
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat-treated PS23 in people with Anxiety Disorders, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from the HAM-A compared to placebo. (time frame: change from baseline score at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.