Clinical trial NCT04753944: Probiotics Therapy of Mood Disorders
Official title: Probiotics Therapy: a New Approach to Therapy of Mood Disorders in Perimenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: probiotics
mood
depressive
therapy
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention, randomized, double-blind, using placebo.
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: Inclusion Criteria:

* must presence of mood disorders confirmed by Beck scale (more than 10 points)
* must be able to swallow tablets

Exclusion Criteria:

* individuals that had prescribed antibiotics, proton pump inhibitors, or probiotics in the 6 months preceding the study (eg. inflammatory bowel syndrome)
* circulatory disorders patients
* diagnosed coagulopathies,
* diagnosed respiratory disease
* inflammatory bowel disease patients
* addicted to alcohol
* addicted to psychoactive substances,

Primary outcomes:
measure: Dietary intervention
timeFrame: 5 weeks
measure: Anthropometric measurements
timeFrame: 5 weeks
measure: Depression intensity mesurements
timeFrame: 5 weeks
measure: The biochemical changes in stool
timeFrame: 5 weeks
measure: The cytometric studies
timeFrame: 5 weeks
measure: The stool microbiota changes
timeFrame: 5 weeks
measure: Insomnia studies
timeFrame: 3 months
measure: The Kynureine Pathway
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Pomeranian Medical University
state: Zachodniopomorskie
Study officials:
affiliation: Pomeranian Medical University in Sczecin
name: Jerzy Samochowiec, prof, MD
role: STUDY_DIRECTOR
References: