depression, obesity , anxiety , fatigue depression, obesity , probiotics ,
Conditions
Interventions
The Capsule Amount per serving containing billion CFU
Lactobacillus crispatus: 6.4 billion CFU
Bifidobacterium animalis subsp. Lactis: 3.6 billion CFU
Bifidobacterium breve: 2.8 billion CFU
Lactobaci
Biosyn Dietary Supplement Product,Standard Treatment
Sponsors
Research Fund, Faculty of Medicine, Thammasat University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged 18 to 55 years who have been diagnosed by a psychiatrist or a resident in the Department of Psychiatry with major depressive disorder according to the ICD-10 criteria, with codes F32.0, F32.1, F32.4, F32.5, F33.0, F33.1, F33.2, and F33.4. F32.0 Major depressive disorder, single episode, mild F32.1 Major depressive disorder, single episode, moderate F32.4 Major depressive disorder, single episode, in partial remission F32.8 Other depressive episodes F32.89 Other specified depressive episodes F32.9 Major depressive disorder, single episode, unspecified F33 Major depressive disorder, recurrent F33.0 Major depressive disorder, recurrent, mild F33.1 Major depressive disorder, recurrent, moderate F33.41 Major depressive disorder, recurrent, in partial remission F33.8 Other recurrent depressive disorders F33.9 Major depressive disorder, recurrent, unspecified 2. Participants must still exhibit symptoms of depression, as assessed by a PHQ-9 score of more than of equal to 9. 3. Participants must be continuously receiving standard treatments, including psychotherapy, antidepressants, and other medications, but they must not have had any recent adjustments to their antidepressant medication in the past 8 weeks. 4. Participants must have a BMI of more than of equal to 23.0 kg/m2 (overweight). 5. Participants must voluntarily consent to participate in the study. 6. Participants must be able to read, write, or understand the Thai language.
Exclusion criteria
Exclusion criteria: 1. Participants who are pregnant 2. Participants currently undergoing treatment for heart disease, immune system disorders, gastrointestinal and biliary diseases, kidney disease, and infectious diseases. 3. Participants who have been diagnosed with cancer. 4. Participants who have taken weight-loss medication in the past month such as Liraglutide, Semaglutide, Orlistat, Phentermine, Lorcaserin, Sibutramine. 5. Participants who have taken antibiotics or immunosuppressive drugs in the past two weeks such asAmoxicillin, Ampicillin, Penicillin V, Cefuroxime, Ceftriaxone, Cefixime, Azithromycin, Clarithromycin, Erythromycin, Ciprofloxacin, Levofloxacin, Moxifloxacin, Doxycycline, Tetracycline, Minocycline, Gentamicin, Amikacin, Sulfamethoxazole, Sulfadiazine, Imipenem, Meropenem, Ertapenem, Vancomycin, Teicoplanin, Clindamycin, Lincomycin, Tacrolimus, Cyclosporin, Methotrexate, Azathioprine, Cisplatin, Cyclophosphamide, Doxorubicin, Bleomycin. 6. Participants with a history of severe allergies to probiotics or their components. 7. Participants who have used probiotics in the past month. 8. Participants with a suicide risk at the Severe level or higher based on the 8Q Suicide Assessment ( more than of equal to 17). 9. Participants who have completed the PHQ-9 questionnaire and have a total score more than of equal to 20 points. 10. Participants with depression and psychiatric conditions, including schizophrenia, dementia, bipolar disorder, or a history of substance use disorder according to DSM-5 criteria, except nicotine use disorder and caffeine use disorder. 11. Participants with known allergies or sensitivities to corn or corn-derived products, including corn starch.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Rating Scale for Depression 2 months after the intervention Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| GAD-7 (Generalized anxiety disorder-7) 2 months after the intervention Questionnaire,CFQ-11 (The Chalder Fatigue Scale) 2 months after the intervention Questionnaire,Beck depression inventory II: BDI-II Thai version questionnaire 2 months after the intervention Questionnaire,Waist Circumference 2 months after the intervention Measuring tape,Weight 2 months after the intervention Scale | — |
Countries
Thailand
Contacts
Public ContactBhoo Chevasutho
Faculty of Medicine, Thammasat University
Outcome results
None listed