Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04753944
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2020-05-07
Brief Title:
Probiotics Therapy of Mood Disorders
Sponsor:
Pomeranian Medical University Szczecin
Organization:
Pomeranian Medical University Szczecin
Study Overview
Official Title:
Probiotics Therapy a New Approach to Therapy of Mood Disorders in Perimenopausal Women
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 proteinplacebo
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 eg 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
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 proteinplacebo
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None