The Intervention of Psychobiotics in Patients With Anxiety Disorders
A legfontosabb adatok
- Ki végzi
- Mackay Memorial Hospital
- Hol
- Tajvan1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 71 fő vett részt
- Kezdés
- 2023. aug. 1.
- Befejezés
- 2025. júl. 31.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- Heat-treated PS23
- Placebo
- A regiszteradat frissítve
- 2025. december 5.
Ki vehet részt
- Életkor
- 20 év – 70 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Have taken antibiotics or are receiving antibiotic treatment within one month
- Patients who have undergone hepatobiliary gastrointestinal surgery (except for colorectal polypectomy and appendectomy)
- 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
- Past or current patients with inflammatory bowel disease
- Those with a history of cancer
- Those who are allergic to lactic acid bacteria products
- Have used probiotic products in powder, capsule or tablet form within two weeks (excluding yogurt, Yakult and other related foods)
- 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
- Those who are evaluated by the principal investigator to be unsuitable to participate in the research
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 2 csoportja
- Heat-treated PS23A vizsgált kezelés
Lactobacillus paracasei PS23 heat-treated
- PlaceboPlacebo, összehasonlításként
microcrystalline cellulose
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- 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
- A regiszteradat frissítve
- 2025. december 5.