ena-STUDY-MEDICAL UNIVERSITY GRAZ-27-10-2020-16:07:24:806-313
Microbial analysis of patients with diagnosed depression after treatment with Probiotics and Placebo.
The PROVIT study was performed as a monocentric, randomized, placebo-controlled study, approved by the local ethics board (EK 29-235 ex 16/17) and registered at clinicaltrials.com (NCT03300440). The term PROVIT was created due to the intake of probiotics and vitamin B7. All subjects recruited were inpatients with a diagnosis of depression of the Department of Psychiatry and Psychotherapeutic Medicine of the Medical University Graz and provided written informed consent after previous written and verbal information. Study visits were performed at the time of inclusion (t0), after one week (t1; only stool) and after 28 days (t2; +/-3 days). Clinical visits included collection of fasting blood, stool, psychological and cognitive testing as well as a clinical interview including side effects of (study) medication and clinical symptoms.The probiotic supplement as well as the placebo was provided by the “Institute Allergosan”, producer of the product was Winclove BV. OMNi-BiOTiC® Stress Repair is a commercial dietary supplement and includes nine bacterial strains with at least 7.5 billion organisms per 1 portion (= 3 g). Bacterial strains in “OMNi-BiOTiC® Stress Repair” are Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus acidophilus W22, Lactobacillus casei W56, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus salivarius W24, Lactococcus lactis W19. In addition, 125mg D-Biotin (vitamin B7), 30 mg of common horsetail, 30 mg of fish collagen, 30 mg of keratin plus matrix was added to the probiotic product. Both groups received biotin additionally (but included in the study medication), due to ethical considerations.
The PROVIT study was performed as a monocentric, randomized, placebo-controlled study, approved by the local ethics board (EK 29-235 ex 16/17) and registered at clinicaltrials.com (NCT03300440). The term PROVIT was created due to the intake of probiotics and vitamin B7. All subjects recruited were inpatients with a diagnosis of depression of the Department of Psychiatry and Psychotherapeutic Medicine of the Medical University Graz and provided written informed consent after previous written and verbal information. Study visits were performed at the time of inclusion (t0), after one week (t1; only stool) and after 28 days (t2; +/-3 days). Clinical visits included collection of fasting blood, stool, psychological and cognitive testing as well as a clinical interview including side effects of (study) medication and clinical symptoms.The probiotic supplement as well as the placebo was provided by the “Institute Allergosan”, producer of the product was Winclove BV. OMNi-BiOTiC® Stress Repair is a commercial dietary supplement and includes nine bacterial strains with at least 7.5 billion organisms per 1 portion (= 3 g). Bacterial strains in “OMNi-BiOTiC® Stress Repair” are Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus acidophilus W22, Lactobacillus casei W56, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus salivarius W24, Lactococcus lactis W19. In addition, 125mg D-Biotin (vitamin B7), 30 mg of common horsetail, 30 mg of fish collagen, 30 mg of keratin plus matrix was added to the probiotic product. Both groups received biotin additionally (but included in the study medication), due to ethical considerations.