Clinical trial NCT05051501: The Effects of Microbiological Spectrum Changes to Improve Cognitive Health in Aging Population
Official title: Biotechnology Research Into Microbiological Spectrum Changes to Improve Cognitive Functions, Depression and Other Neuropsychiatric Disorders in Aging Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Memory Deficits
Mood Change
Gut Health
Aging Problems
Aging
Cognitive Decline
Keywords: Probiotics
Microbiome
Gut Microflora
Cognitive Health
Lead sponsor: National Institute of Mental Health, Czech Republic
Sponsor class: OTHER
Collaborators: name: C2P s.r.o.
name: University Hospital Vinohrady
name: Ministry of Industry and Trade, Czech Republic
First posted: 2021-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: First 3 months: group A on probiotics; group B on placebo Next 3 months: group A on placebo; group B on probiotics. Next 3 months: no intervention in either group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this project is to develop probiotic dietary supplements intended for the elderly, which can modify the composition of the intestinal microbiota typically occurring in the aging population. According to currently held scientific knowledge, it is postulated that the probiotics-induced normalization of the physiological axis in the brain-intestinal microbiota affects the activity of the nervous system. Thus, normalization of this axis should lead to observable improvements in cognitive functions and quality of life.

Detailed description: With an increasing age of the population, the incidence of age-related problems, such as memory deficits or negative changes in mood, is on the rise. On this account, an increased emphasis has been placed on identifying natural ways to reduce the occurrence of such problems. One of the proposed methods to achieve this is to modify the composition of gut bacteria and their by-products, which has shown a surprising, yet highly promising potential to benefit the brain function and blood composition.

In the recent years, gut bacteria have been of great interest to many medical professionals from various disciplines. It is postulated that they might exert some influence on memory and emotions, but there is a lack of evidence to confirm these hypotheses. Our study would like to address this issue and examine the beneficial effects of probiotics into more depth. Probiotics are dietary supplements in the form of bacteria, which are often artificially added e.g. into some dairy products. This is done to promote gut health and to improve the quality of gut microflora.

The subject selection and assessment are summarised as follows: Participants will be pre-selected electronically and given an electronic memory test. Further selection of eligible subjects based on their preliminary results will be followed by the first personal appointment, where each participant will undergo memory and mood-focused psychological testing and testing for gut bacteria composition. One week after the initial appointment, participants will be asked to bring in a stool and urine sample, their blood will be collected and their fitness and dietary habits assessed. Each participant will also be given an electronic watch, which will monitor their physical activity, and supplements in the pill form, which either contain specially cultivated human gut bacteria (i.e. probiotics) or placebo. Identical tests and blood, urine and stool collection will be repeated three months after administering the first pill. The participants will receive another set of pills, which will contain the probiotics if the participant has initially received placebo and vice versa. After three more months, participants will be subjected to the same tests as in the previous two instants. To test for lasting effects of treatment, participants will be tested again after 3 more months and the project will reach its termination.

Using the above-mentioned methods, the aim of this project is to provide sufficient evidence of the beneficial effects of the new probiotics on memory, mood and the biochemical components contained in the blood, stool and urine in elderly population.

Eligibility criteria: Inclusion Criteria:

* is 55-80 years of age
* His/her native language is Czech
* Is willing to visit the testing centre four times within half a year
* Is willing to provide blood, urine and stool samples three times within half a year
* Is willing to self-administer the probiotic/placebo pill once every day for half a year
* is self-sufficient (handling finances, travelling without a chaperone, administration of medication, correct phone usage, filling forms, meal preparation)
* Has good vision; Can read and write, glasses are acceptable
* Has good hearing to hear and understand all instructions during examination
* Can walk well (walking aids are acceptable) to attend all the examinations

Exclusion Criteria:

* Suffers with disorder(s) of digestive system, primarily gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease, frequent diarrhoea)
* Had severe neurological difficulties (epilepsy, stroke, severe head trauma, meningitis in the past 10 years, brain surgery, brain tumour, prolonged period(s) in an unconscious state - excluding general anaesthesia)
* Had been treated/Is currently being treated for the following psychiatric disorders: alcohol/medication/drug of abuse dependance, schizophrenia, psychotic disorder, bipolar disorder
* Is taking medication for depression or low mood
* Suffers from internal organ failure (heart, liver or kidney failure etc.)
* Suffered from an oncological problem (cancer) in the past 5 years
* Underwent radiotherapy or chemotherapy in the past
* Underwent a surgery/procedure under general anaesthesia in the past three years or has a planned procedure/surgery under general anaesthesia in the next 6 months over the course of this trial
* Suffered from hepatitis (hepatitis B, C), HIV or syphilis in the past
* Had taken any probiotics in the past three months

Primary outcomes:
measure: Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 9 months
timeFrame: 6 months to 9 months
measure: Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months cognitive function in the Assessment Battery of Cognition (ABACO) at 9 months
timeFrame: 6 months to 9 months
measure: Difference in cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months cognitive function in Semantic word recollection (category: animals, 1 min) at 9 months
timeFrame: 6 months to 9 months
measure: Difference in cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 9 months
timeFrame: 6 months to 9 months
measure: Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months
timeFrame: baseline to 3 months
measure: Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months
timeFrame: baseline to 6 months
measure: Change in 3 month cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months
timeFrame: 3 months to 6 months
measure: Change in 6 month cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 9 months
timeFrame: 6 months to 9 months
measure: Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 3 months
timeFrame: baseline to 3 months
measure: Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 6 months
timeFrame: baseline to 6 months
measure: Change in 3 month cognitive function in Trail Making Test (TMT), Parts A & B at 6 months
timeFrame: 3 months to 6 months
measure: Change in 6 month cognitive function in Trail Making Test (TMT), Parts A & B at 9 months
timeFrame: 6 months to 9 months
measure: Difference cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference cognitive function in Trail Making Test (TMT), Parts A & B at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change in baseline mood in Geriatric Depression Scale at 3 months.
timeFrame: baseline to 3 months
measure: Change in baseline mood in Geriatric Depression Scale at 6 months.
timeFrame: baseline to 6 months
measure: Change in 3 month mood in Geriatric Depression Scale at 6 months.
timeFrame: 3 months to 6 months
measure: Change in 6 month mood in Geriatric Depression Scale at 9 months.
timeFrame: 6 months to 9 months
measure: Difference in mood in Geriatric Depression Scale at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in mood in Geriatric Depression Scale at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 month self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 month self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 9 months
timeFrame: 6 months to 9 months
measure: Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Changes in tau protein
timeFrame: baseline to 3 months
measure: Changes in tau protein
timeFrame: baseline to 6 months
measure: Changes in tau protein
timeFrame: 3 months to 6 months
measure: Changes in tau protein
timeFrame: 6 months to 9 months
measure: Changes in neurofilament light levels
timeFrame: baseline to 3 months
measure: Changes in neurofilament light levels
timeFrame: baseline to 6 months
measure: Changes in neurofilament light levels
timeFrame: 3 months to 6 months
measure: Changes in neurofilament light levels
timeFrame: 6 months to 9 months
measure: Changes in immunocomplex antibody levels
timeFrame: baseline to 3 months
measure: Changes in immunocomplex antibody levels
timeFrame: baseline to 6 months
measure: Changes in immunocomplex antibody levels
timeFrame: 3 months to 6 months
measure: Changes in immunocomplex antibody levels
timeFrame: 6 months to 9 months
measure: Biochemical parameters in blood
timeFrame: baseline to 3 months
measure: Biochemical parameters in blood
timeFrame: baseline to 6 months
measure: Biochemical parameters in blood
timeFrame: 3 months to 6 months
measure: Biochemical parameters in blood
timeFrame: 6 months to 9 months
measure: Biochemical parameters in urine
timeFrame: baseline to 3 months
measure: Biochemical parameters in urine
timeFrame: baseline to 6 months
measure: Biochemical parameters in urine
timeFrame: 3 months to 6 months
measure: Biochemical parameters in urine
timeFrame: 6 months to 9 months
measure: Biochemical parameters in stool
timeFrame: baseline to 3 months
measure: Biochemical parameters in stool
timeFrame: baseline to 6 months
measure: Biochemical parameters in stool
timeFrame: 3 months to 6 months
measure: Biochemical parameters in stool
timeFrame: 6 months to 9 months
Secondary outcomes:
measure: Change from baseline Questionnaire of adverse events (abbreviation in original language: DNU) at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months Questionnaire of adverse events (abbreviation in original language: DNU) at 9 months
timeFrame: 6 months to 9 months
measure: Difference in the Questionnaire of adverse events (abbreviation in original language: DNU) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in the Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline Self-assessment of memory at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline Self-assessment of memory at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months Self-assessment of memory at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months Self-assessment of memory at 9 months
timeFrame: 6 months to 9 months
measure: Difference in Self-assessment of memory at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in Self-assessment of memory at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline Self-assessment of digestion at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline Self-assessment of digestion at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months Self-assessment of digestion at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months Self-assessment of digestion at 9 months
timeFrame: 6 months to 9 months
measure: Difference in Self-assessment of digestion at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in Self-assessment of digestion at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline Self-assessment of overall health at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline Self-assessment of overall health at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months Self-assessment of overall health at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months Self-assessment of overall health at 9 months
timeFrame: 6 months to 9 months
measure: Difference in Self-assessment of overall health at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in Self-assessment of overall health at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline Self-assessment of sleep quality at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline Self-assessment of sleep quality at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months Self-assessment of sleep quality at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months Self-assessment of sleep quality at 9 months
timeFrame: 6 months to 9 months
measure: Difference in Self-assessment of sleep quality at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in Self-assessment of sleep quality at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline Self-assessment of anxiety at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline Self-assessment of anxiety at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months Self-assessment of anxiety at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months Self-assessment of anxiety at 9 months
timeFrame: 6 months to 9 months
measure: Difference in Self-assessment of anxiety at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in Self-assessment of anxiety at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline Self-assessment of fatigue at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline Self-assessment of fatigue at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months Self-assessment of fatigue at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months Self-assessment of fatigue at 9 months
timeFrame: 6 months to 9 months
measure: Difference in Self-assessment of fatigue at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in Self-assessment of fatigue at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline Self-assessment of pain at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline Self-assessment of pain at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months Self-assessment of pain at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months Self-assessment of pain at 9 months
timeFrame: 6 months to 9 months
measure: Difference in Self-assessment of pain at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in Self-assessment of pain at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline physical condition assessment in 30 second sit stand test at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline physical condition assessment in 30 second sit stand test at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months physical condition assessment in 30 second sit stand test at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months physical condition assessment in 30 second sit stand test at 9 months
timeFrame: 6 months to 9 months
measure: Difference in physical condition assessment in 30 second sit stand test at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in physical condition assessment in 30 second sit stand test at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline physical condition assessment in 30 second dumbell lift tests at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline physical condition assessment in 30 second dumbell lift tests at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months physical condition assessment in 30 second dumbell lift tests at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months physical condition assessment in 30 second dumbell lift tests at 9 months
timeFrame: 6 months to 9 months
measure: Difference in physical condition assessment in 30 second dumbell lift tests at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in physical condition assessment in 30 second dumbell lift tests at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline physical condition assessment in 30 meters walk at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline physical condition assessment in 30 meters walk at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months physical condition assessment in 30 meters walk at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months physical condition assessment in 30 meters walk at 9 months
timeFrame: 6 months to 9 months
measure: Difference in physical condition assessment in 30 meters walk at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in physical condition assessment in 30 meters walk at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change from baseline Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 3 months
timeFrame: baseline to 3 months
measure: Change from baseline Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months
timeFrame: baseline to 6 months
measure: Change from 3 months Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months
timeFrame: 3 months to 6 months
measure: Change from 6 months Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 9 months
timeFrame: 6 months to 9 months
measure: Difference in Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change in baseline Beck's Anxienty Inventory at 3 months
timeFrame: baseline to 3 months
measure: Change in baseline Beck's Anxienty Inventory at 6 months
timeFrame: baseline to 6 months
measure: Change in 3 months Beck's Anxienty Inventory at 6 months
timeFrame: 3 months to 6 months
measure: Change in 6 months Beck's Anxienty Inventory at 9 months
timeFrame: 6 months to 9 months
measure: Difference in Beck's Anxienty Inventory at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in Beck's Anxienty Inventory (BAI) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
measure: Change in baseline Beck's Depression Inventory - II (BDI-II) at 3 months
timeFrame: baseline to 3 months
measure: Change in baseline Beck's Depression Inventory - II (BDI-II) at 6 months
timeFrame: baseline to 6 months
measure: Change in 3 months Beck's Depression Inventory - II (BDI-II) at 6 months
timeFrame: 3 months to 6 months
measure: Change in 6 months Beck's Depression Inventory - II (BDI-II) at 9 months
timeFrame: 6 months to 9 months
measure: Difference in Beck's Depression Inventory - II (BDI-II) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 3 months
measure: Difference in Beck's Depression Inventory - II (BDI-II) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group
timeFrame: 6 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: University Hospital Vinohrady
city: Prague
country: Czechia
facility: National Institute of Mental Health, Czech Republic
Study officials:
References: