Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02469545
• Date of registration: 29/05/2015
• Prospective Registration: No
• Primary sponsor: Medical University of Bialystok
• Public title: Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment
• Scientific title: Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment
• Date of first enrolment: June 2014
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02469545
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Poland

Contacts

• Name: Napoleon Waszkiewicz, MD PhD
• Affiliation: Psychiatry Department of Bialystok Medical University

• Name: Leszek Z Rudzki, MD Psychiatry Specialist
• Affiliation: Department of Psychiatry, Medical University of Bialystok

Key inclusion & exclusion criteria

Inclusion Criteria:

- Unipolar depression, with at least one depressive episode, present episode since at
least 2 weeks, with Hamilton Depression Scale scoring 18 and higher with BMI =18,9 -
29,9 kg/m2

Exclusion Criteria:

- Inflammatory diseases eg. rheumatoid diseases, inflammatory bowel diseases,
autoimmunological diseases

- Metabolic diseases e.g. diabetes type I,II, obesity (Body Mass Index)>30 kg/m2

- Previously diagnosed other psychiatric diseases other than depression, psychoactive
substances abuse, organic brain dysfunctions

- Smokers

- Patients after surgeries in last 3 months

- Oncological patients

- Patients during pregnancy or lactation

- Drugs which might influence measured parameters (e.g. lithium, antibiotics,
glucocorticosteroids, antipsychotic drugs)

- Changes in routine blood biochemical parameters: morphology, electrolytes, Aspartate
Aminotransferase (AST), Alanine Aminotransferase (ALT), creatinine, urea, C-reactive
protein (CRP), thyroid-stimulating hormone (TSH).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anxiety Disorder

Depression

Intervention(s)

Drug: Lactobacillus Plantarum 299v

Drug: Escitalopram

Drug: Sertraline

Drug: Crystalline cellulose powder

Primary Outcome(s)

Evaluation of psychometric parameters - Change in Hamilton Depression Rating Scale from baseline at 3 weeks and 8 weeks of the study. [Time Frame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study]

Evaluation of psychometric parameters - Change in Perceived Stress Scale (PSS-10) from baseline at 3 weeks and 8 weeks of the study. [Time Frame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study]

Evaluation of psychometric parameters - Change in Symptom Checklist 90 Scale (SCL-90) from baseline at 3 weeks and 8 weeks of the study. [Time Frame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study]

Secondary Outcome(s)

Cognitive functions evaluation - Stroop Test (A and B) [Time Frame: At day one, after 8 weeks (day 56) of the study]

Biochemical analysis - cytokines measurements profile [Time Frame: At day one, after 8 weeks (day 56) of the study]

Cognitive functions evaluation - Connecting Points Test (A and B) [Time Frame: At day one, after 8 weeks (day 56) of the study]

Biochemical analysis - kynurenic pathway metabolites measurements profile [Time Frame: At day one, after 8 weeks (day 56) of the study]

Cognitive functions evaluation - Attention and Perceptivity Test [Time Frame: At day one, after 8 weeks (day 56) of the study]

Cognitive functions evaluation - California Verbal Learning Test (CVLT) [Time Frame: At day one, after 8 weeks (day 56) of the study]

Cognitive functions evaluation - Ruff Figural Fluency Test (RFFT) [Time Frame: At day one, after 8 weeks (day 56) of the study]

Biochemical analysis - morning cortisol level [Time Frame: At day one, after 8 weeks (day 56) of the study]

Secondary ID(s)

133-47818

Source(s) of Monetary Support

Please refer to primary and secondary sponsors