Probiotics Therapy of Mood Disorders
Condition: Depression
MeSH terms: Mood Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Active Comparator: Probiotic; Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; Patients will be introduced for 5 weeks with placebo consisting of starch, maltodextrins and vegetable protein. The placebo dose is going to be 4 capsules daily. The treatment will be administered two times a day, during breakfast and supper.
Other intervention name(s): Probiotic Ecologic®Barrier (Winclove Probiotics BV); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention, randomized, double-blind, using placebo.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: probiotics; mood; depressive; therapy