Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04753944 |
Other study ID # |
Pomeranian Medical Univeristy |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 1, 2018 |
Est. completion date |
April 3, 2020 |
Study information
Verified date |
February 2021 |
Source |
Pomeranian Medical University Szczecin |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.