Depressive Disorder
Conditions
Interventions
This is a randomized, placebo controlled, two arm, double blind, single center clinical trial with parallel groups and total duration of twelve weeks. Sixty adult participants followed at the outpatie
Sponsors
Universidade Santo Amaro
Universidade Santo Amaro
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes aged eighteen to sixty five years; followed at the Universidade Santo Amaro outpatient clinic; presence of mild to moderate depressive and or anxiety symptoms at baseline, defined by PHQ-9 and or GAD-7 scores compatible with mild to moderate symptoms or clinical indication for follow-up due to depressive and anxious symptoms; stable usual pharmacological and or psychotherapeutic treatment for at least four weeks before baseline, with intention to maintain it during the study; ability to understand and sign the informed consent form
Exclusion criteria
Exclusion criteria: Current use of probiotics or synbiotics or recent initiation of probiotics within the past four weeks; systemic antifungal use during the study period or foreseeable need for antifungal use due to possible interference with Saccharomyces boulardii; significant immunosuppression, uncontrolled severe disease or any clinical condition that, according to the clinic judgment, increases the risk of infectious events; presence of a central venous catheter; known hypersensitivity to yeasts or any component of the formulation; pregnancy or breastfeeding; current psychotic or manic episode or acute suicidal risk requiring immediate intervention according to clinic routine; systemic antibiotic use within four weeks before baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in depression scores assessed by the Patient Health Questionnaire-9 (PHQ-9) between the beginning of the study and after twelve weeks, with intermediate assessments after four weeks and after eight weeks;It is expected to find a reduction in anxiety scores assessed by the Generalized Anxiety Disorder-7 (GAD-7) between the beginning of the study and after twelve weeks, with intermediate assessments after four weeks and after eight weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find improvement in quality of life assessed by the World Health Organization Quality of Life Bref (WHOQOL-BREF) at the beginning of the study, after four weeks, after eight weeks and after twelve weeks;It is expected to find improvement in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI) at the beginning of the study, after four weeks, after eight weeks and after twelve weeks;It is expected to find improvement in bowel habits assessed by the Bristol Stool Form Scale and bowel movement frequency at the beginning of the study, after four weeks, after eight weeks and after twelve weeks;It is expected to find good safety and adherence to daily capsule use, assessed by the occurrence of adverse events, capsule count and simple diary record during the twelve weeks of the study | — |
Countries
BR
Contacts
Public ContactAlexandre Junior
Universidade Santo Amaro
Outcome results
None listed