Effects of a probiotic food supplement on depressive symptoms in adults

Not Applicable

• Conditions: Sub-threshold Depression; Mental Health - Depression

• Registration Number: ACTRN12621000675820
• Lead Sponsor: a Trobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-03
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

•Not in the underweight category (BMI greater than or equal to 18.5 kg/m2);
•Meet the criteria for subthreshold depression;
•Have not been taking antidepressants or other medications acting on the CNS for at least 6 weeks (all potential participants will be advised to not stop taking any medication prior to consulting their GP);

Exclusion Criteria

•Patients with comorbidity with substance use disorders or organic mental disorders;
•Patients with neurological conditions affecting the brain or other central functions;
•Patients with organic co-morbidities affecting, in particular, the gastrointestinal system, or autoimmune or chronic inflammatory conditions;
•Patients who are taking nutritional supplements containing vitamins, minerals or antioxidants in the six weeks before the start of the trial participation;
•Patients who have been taking antibiotics in the six weeks before the start of the trial participation;
•Patients who are pregnant or are breastfeeding;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in depression score between the intervention and control groups, using thePatient Health Questionnaire (PH9) self-report, brief questionnaire that measures depression.[Weekly from baseline for 3 months post-commencement of intervention];Change in depression score between intervention and control groups, using the Depression, Anxiety and Stress Scale for the depression axis (DASS-21; self-report) <br>[Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)];Change in depression score between intervention and control groups, using the Beck Depression Inventory (BDI-II; self-report)[Pre-intervention, mid-intervention (6 weeks) and post-intervention (12 weeks)]