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Probiotics Therapy: a New Approach to Therapy of Mood Disorders in Perimenopausal Women
The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.
The aim: The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group. The study hypothesis: By using periodic probiotics therapy it is possible to positively influence the mood of women with depressive syndromes. These efforts focus on the improvement of the functioning of the gut barrier and gut-brain axis. In practice, such activities should lead to the reduction in the dysfunction of the barrier, the reduction of endotoxemia and the concentration of neurotoxic metabolites of tryptophan (in blood) with the simultaneous increase in the content of butyric acid that has a neuroprotective effect. The of the trial: intervention, cohort, randomized, double-blind, using placebo. A multi-strain probiotic will also be provided ( Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58 or maize starch, maltodextrins and vegetable protein/placebo). The applied method of study: 1. a controlled dietary intervention that includes probiotics therapy; the verification of the past nutritional pattern (the Food Frequency Questionnaire); anthropometric measurements; 2. psychiatric studies: the evaluation of sleep disorders (the Athens insomnia scale) and mood (the Beck scale), and the worsening of depression (the Hamilton scale); 3. biochemical studies: the content of short chain fatty acids (in the stool); 4. cytometric studies (B-type lymphocytes' panel, T-type lymphocytes' panel, regulatory T cells' panel); 5. genetic (the microbiome of bacteria in the stool, pyrosequencing); 6. chromatographic (the derivatives of tryptophan e.g., kynurenine, anthranilic acid, kynureic acid, 3-hydroxykynurenine, 5-hydroxytryptophan, serotonin). Currently, there is an urgent problem to develop recommendations regarding the nutrition and probiotics therapy that could complement the therapy of women with mood disorders. If the achieved results confirm the study hypothesis, it will be possible to: 1. better understand the pathomechanism of mood disorders in the perimenopausal period; 2. develop a holistic strategy for depressive disorders in women in the menopause period.
Age
40 - 60 years
Sex
FEMALE
Healthy Volunteers
No
Pomeranian Medical University
Szczecin, West Pomeranian Voivodeship, Poland
Start Date
December 1, 2018
Primary Completion Date
January 1, 2019
Completion Date
April 3, 2020
Last Updated
February 16, 2021
60
ACTUAL participants
Active Comparator: Probiotic
DIETARY_SUPPLEMENT
Placebo group
DIETARY_SUPPLEMENT
Lead Sponsor
Pomeranian Medical University Szczecin
NCT07360600
NCT06793397
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