Probiotics Therapy of Mood Disorders

Pomeranian Medical University Szczecin

Status: Completed

Conditions: Depression

Treatments: Dietary Supplement: Placebo group; Dietary Supplement: Active Comparator: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT04753944

Pomeranian Medical Univeristy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Probiotic group

Active Comparator group

Description:

Patients will be introduced for 5 weeks with probiotic therapy (in the study group). They will take Ecologic®Barrier (Winclove Probiotics BV, Amsterdam, The Netherlands), consisting of 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. The probiotic dose is going to be 4 capsules daily (one capsule contains 500 million CFUs of living probiotic strains). The treatment will be administered two times a day, during breakfast and supper. The probiotic formula will be Provided by polish distributor of Winclove products, namely Sanprobi sp. z o. o. sp. k

Treatment:

Dietary Supplement: Active Comparator: Probiotic

Placebo group

Placebo Comparator group

Description:

Patients will be introduced for 5 weeks with placebo that consist of maize starch, maltodextrins and vegetable protein. The placebo dose is going to be 4 capsules daily (one capsule). The treatment will be administered two times a day, during breakfast and supper.

Treatment:

Dietary Supplement: Placebo group