Probiotics Therapy of Mood Disorders

Depression Clinical Trial

Official title:

Probiotics Therapy: a New Approach to Therapy of Mood Disorders in Perimenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753944
• Other study ID #: Pomeranian Medical Univeristy
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 3, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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,

Related Conditions & MeSH terms

• Depression
• Mood Disorders

Intervention

Dietary Supplement:
• Active Comparator: Probiotic
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.
• Placebo 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.

Locations

Country	Name	City	State
Poland	Pomeranian Medical University	Szczecin	Zachodniopomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary intervention	The verification of the past nutritional pattern (will be asses by Food Freguency Questionnarie). The indicate frequency of food consumption, respondents could choose one of six categories (next converted by researcher into daily frequency): never or very rarely (0 times/day), once a month or less (0.025 times/day), several times a month (0.1 times/day), several times a week (0.571 times/day), daily (1 time/day), or a few times a day (2 times/day)	5 weeks
Primary	Anthropometric measurements	The verification of body mass during the study will be asses by body mass index (BMI). In order of this, we will measure the height (outcome in cm). BMI will be calculated by dividing body weight (in kilograms) by height squared (in meters).i Finally BMI will be presented in kg/m2.	5 weeks
Primary	Depression intensity mesurements	Depression intensity will be asses by the Hamilton Rating Scale for Depression (HRSD).Unit HRSD ( 0-7 not depressed, 8-13 mild depression; 14-18 moderate depression (mild); 19-22 moderate depression; > 23 severe depression)	5 weeks
Primary	The biochemical changes in stool	Observation of biochemical changes short fatty acids (SCFAs) concentration before and after the intervention (SCFA in ng/ml)	5 weeks
Primary	The cytometric studies	Observation of a change in Mean Fluorescence Intensity (FSC) of lymphocytes B and regulatory T cells before and after intervention in flow cytometry. Assessments by median: midpoint of the population (middle channel)).	5 weeks
Primary	The stool microbiota changes	Changes in gut microbiota composition and metabolism (16 SrRNA bacterial genomic, bacterial metabolites) at enrollment and at the end-point ( gut microbiota will be asses in Operational taxonomic units (OTUs))	5 weeks
Primary	Insomnia studies	Assessments using unique measurements Athens insomnia scale ( 0 to < 6 means no insomnia; more than 6 points indicated diagnosis of insomnia)	3 months
Primary	The Kynureine Pathway	The changes in the tryptophan pathway derivatives before and after intervention will be measured. ( we assess metabolites of kynurenine pathway e.g. 5 HT, HIAA, KYN will be asses by HPLC (in ng/ml)	3 months