The Effect of Probiotic Supplementation on the Self-Reported Indicators of Depression and Associated Biomarkers : a Double-blind, Randomized, Placebo-Controlled Trial
Tahapan Penelitian : Complete
Sponsor:
Prodi Kedokteran Jiwa FK Undip
Mitra Pelaksana:
Not Specified
No Registry
INA-803LQGC3
Tanggal Input Registry : 04-03-2025
Tracking Information | |
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Tanggal Antisipasi Studi | 08-10-2018 |
Outcome Primer | The primary outcomes included changes in depression severity, measured using the Beck Depression Inventory-II (BDI-II), |
Outcome Skunder | as well as serum levels of IL-6, cortisol, and serotonin, which were measured before and after the intervention. |
Descriptive Information | |
Judul Penelitian Popular | The Effect of Probiotic Supplementation on the Self-Reported Indicators of Depression and Associated Biomarkers : a Double-blind, Randomized, Placebo-Controlled Trial |
Judul Penelitian Ilmiah | The Effect of Probiotic Supplementation on the Self-Reported Indicators of Depression and Associated Biomarkers : a Double-blind, Randomized, Placebo-Controlled Trial |
Jenis Penelitian | Interventional |
Intervensi | probiotic capsules containing Lactobacillus rhamnosus Rosell-11 and Lactobacillus helveticus Rosell-52 at a dose of 2 x 109 CFU |
Jumlah Subyek Penelitian | 100 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: Participants had to be non-smokers and free from antibiotic use for at least one week before starting the interventionExclusion Criteria: We excluded individuals with contraindications to antidepressants, substance abuse disorders, severe physical illnesses, and psychotic disorders. Before participation, all patients provided written informed consent after receiving detailed information about the study’s purpose, procedures, potential benefits, and risks. |
Administrative Information | |
Nomor Persetujuan Etik | No. 014/EC/KEPK-RSDK-2018 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
Other Study ID Numbers | |
Contact Person | ALIFIATI FITRIKASARI |