The Effects of Microbiological Spectrum Changes to Improve Cognitive Health in Aging Population (CleverAgeBiota)

Biotechnology Research Into Microbiological Spectrum Changes to Improve Cognitive Functions, Depression and Other Neuropsychiatric Disorders in Aging Population

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.

Study Overview

• Status: Completed
• Conditions: Aging; Cognitive Decline; Mood Change; Aging Problems; Memory Deficits; Gut Health
• Intervention / Treatment: Dietary supplement: Probiotics C2P

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 10034
    • University hospital Vinohrady
  • Prague, Czechia, 25067
    • National Institute of Mental Health, Czech Republic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics C2P/Placebo; Crossover design does not confine one group of patients strictly either to an intervention in question or a placebo. Each group will receive both placebo and probiotics in tandem, but in a reversed order.	Dietary supplement: Probiotics C2P; Probiotics will supplement normal diet. Unlike other products available on the market, which are usually of bovine origin, our probiotic has been manufactured using human-stemmed lines. The supplements are composed of a mixture of naturally occurring human gut bacteria.
Experimental: Placebo/Probiotics C2P; Crossover design does not confine one group of patients strictly either to an intervention in question or a placebo. Each group will receive both placebo and probiotics in tandem, but in a reversed order.	Dietary supplement: Probiotics C2P; Probiotics will supplement normal diet. Unlike other products available on the market, which are usually of bovine origin, our probiotic has been manufactured using human-stemmed lines. The supplements are composed of a mixture of naturally occurring human gut bacteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months	Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome	baseline to 3 months
Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months	RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm	baseline to 3 months
Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months	The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome	baseline to 3 months
Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 3 months	The TMT is a validated measure of cognitive function, the time upon completion is measured	baseline to 3 months
Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months	FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome	baseline to 3 months
Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months	ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome	baseline to 3 months
Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months	ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome	baseline to 6 months
Change from 3 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months	ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome	3 months to 6 months
Change from 6 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 9 months	ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome	6 months to 9 months
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	ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome	3 months
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	ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome	6 months
Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months	ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome	baseline to 3 months
Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months	ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome	baseline to 6 months
Change from 3 months cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months	ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome	3 months to 6 months
Change from 6 months cognitive function in the Assessment Battery of Cognition (ABACO) at 9 months	ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome	6 months to 9 months
Difference in cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome	3 months
Difference in cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome	6 months
Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months	Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome	baseline to 6 months
Change from 3 months cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months	Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome	3 months to 6 months
Change from 6 months cognitive function in Semantic word recollection (category: animals, 1 min) at 9 months	Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome	6 months to 9 months
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	Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome	3 months
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	Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome	6 months
Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months	RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm	baseline to 6 months
Change from 3 months cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months	RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm	3 months to 6 months
Change from 6 months cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 9 months	RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm	6 months to 9 months
Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm	3 months
Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm	6 months
Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months	The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome	baseline to 6 months
Change in 3 month cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months	The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome	3 months to 6 months
Change in 6 month cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 9 months	The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome	6 months to 9 months
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	The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome	3 months
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	The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome	6 months
Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 6 months	The TMT is a validated measure of cognitive function, the time upon completion is measured	baseline to 6 months
Change in 3 month cognitive function in Trail Making Test (TMT), Parts A & B at 6 months	The TMT is a validated measure of cognitive function, the time upon completion is measured	3 months to 6 months
Change in 6 month cognitive function in Trail Making Test (TMT), Parts A & B at 9 months	The TMT is a validated measure of cognitive function, the time upon completion is measured	6 months to 9 months
Difference cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	The TMT is a validated measure of cognitive function, the time upon completion is measured	3 months
Difference cognitive function in Trail Making Test (TMT), Parts A & B at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	The TMT is a validated measure of cognitive function, the time upon completion is measured	6 months
Change in baseline mood in Geriatric Depression Scale at 3 months.	A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome	baseline to 3 months
Change in baseline mood in Geriatric Depression Scale at 6 months.	A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome	baseline to 6 months
Change in 3 month mood in Geriatric Depression Scale at 6 months.	A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome	3 months to 6 months
Change in 6 month mood in Geriatric Depression Scale at 9 months.	A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome	6 months to 9 months
Difference in mood in Geriatric Depression Scale at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome	3 months
Difference in mood in Geriatric Depression Scale at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome	6 months
Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months	FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome	baseline to 6 months
Change from 3 month self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months	FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome	3 months to 6 months
Change from 6 month self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 9 months	FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome	6 months to 9 months
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	FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome	3 months
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	FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome	6 months
Changes in tau protein	Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels	baseline to 3 months
Changes in tau protein	Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels	baseline to 6 months
Changes in tau protein	Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels	3 months to 6 months
Changes in tau protein	Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels	6 months to 9 months
Changes in neurofilament light levels	Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels	baseline to 3 months
Changes in neurofilament light levels	Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels	baseline to 6 months
Changes in neurofilament light levels	Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels	3 months to 6 months
Changes in neurofilament light levels	Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels	6 months to 9 months
Changes in immunocomplex antibody levels	Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels	baseline to 3 months
Changes in immunocomplex antibody levels	Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels	baseline to 6 months
Changes in immunocomplex antibody levels	Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels	3 months to 6 months
Changes in immunocomplex antibody levels	Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels	6 months to 9 months
Biochemical parameters in blood	Change from baseline Blood metabolome assessed using mass spectrometry at 3 months	baseline to 3 months
Biochemical parameters in blood	Change from baseline Blood metabolome assessed using mass spectrometry at 6 months	baseline to 6 months
Biochemical parameters in blood	Change from 3 months Blood metabolome assessed using mass spectrometry at 6 months	3 months to 6 months
Biochemical parameters in blood	Change from 3 months Blood metabolome assessed using mass spectrometry at 6 months	6 months to 9 months
Biochemical parameters in urine	15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from baseline Urine metabolome assessed using mass spectrometry at 3 months	baseline to 3 months
Biochemical parameters in urine	15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from baseline Urine metabolome assessed using mass spectrometry at 6 months	baseline to 6 months
Biochemical parameters in urine	15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from 3 months Urine metabolome assessed using mass spectrometry at 6 months	3 months to 6 months
Biochemical parameters in urine	15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from 3 months Urine metabolome assessed using mass spectrometry at 6 months	6 months to 9 months
Biochemical parameters in stool	Change from baseline Stool metabolome assessed using mass spectrometry at 3 months	baseline to 3 months
Biochemical parameters in stool	Change from baseline Stool metabolome assessed using mass spectrometry at 6 months	baseline to 6 months
Biochemical parameters in stool	Change from 3 months Stool metabolome assessed using mass spectrometry at 6 months	3 months to 6 months
Biochemical parameters in stool	Change from 3 months Stool metabolome assessed using mass spectrometry at 6 months	6 months to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Questionnaire of adverse events (abbreviation in original language: DNU) at 3 months	DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events	baseline to 3 months
Change from baseline Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months	DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events	baseline to 6 months
Change from 3 months Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months	DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events	3 months to 6 months
Change from 6 months Questionnaire of adverse events (abbreviation in original language: DNU) at 9 months	DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events	6 months to 9 months
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	DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events	3 months
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	DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events	6 months
Change from baseline Self-assessment of memory at 3 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	baseline to 3 months
Change from baseline Self-assessment of memory at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	baseline to 6 months
Change from 3 months Self-assessment of memory at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	3 months to 6 months
Change from 6 months Self-assessment of memory at 9 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	6 months to 9 months
Difference in Self-assessment of memory at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	3 months
Difference in Self-assessment of memory at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	6 months
Change from baseline Self-assessment of digestion at 3 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	baseline to 3 months
Change from baseline Self-assessment of digestion at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	baseline to 6 months
Change from 3 months Self-assessment of digestion at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	3 months to 6 months
Change from 6 months Self-assessment of digestion at 9 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	6 months to 9 months
Difference in Self-assessment of digestion at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	3 months
Difference in Self-assessment of digestion at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	6 months
Change from baseline Self-assessment of overall health at 3 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	baseline to 3 months
Change from baseline Self-assessment of overall health at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	baseline to 6 months
Change from 3 months Self-assessment of overall health at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	3 months to 6 months
Change from 6 months Self-assessment of overall health at 9 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	6 months to 9 months
Difference in Self-assessment of overall health at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	3 months
Difference in Self-assessment of overall health at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	6 months
Change from baseline Self-assessment of sleep quality at 3 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	baseline to 3 months
Change from baseline Self-assessment of sleep quality at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	baseline to 6 months
Change from 3 months Self-assessment of sleep quality at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	3 months to 6 months
Change from 6 months Self-assessment of sleep quality at 9 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	6 months to 9 months
Difference in Self-assessment of sleep quality at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	3 months
Difference in Self-assessment of sleep quality at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	6 months
Change from baseline Self-assessment of anxiety at 3 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome	baseline to 3 months
Change from baseline Self-assessment of anxiety at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome	baseline to 6 months
Change from 3 months Self-assessment of anxiety at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome	3 months to 6 months
Change from 6 months Self-assessment of anxiety at 9 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome	6 months to 9 months
Difference in Self-assessment of anxiety at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome	3 months
Difference in Self-assessment of anxiety at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome	6 months
Change from baseline Self-assessment of fatigue at 3 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome	baseline to 3 months
Change from baseline Self-assessment of fatigue at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome	baseline to 6 months
Change from 3 months Self-assessment of fatigue at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome	3 months to 6 months
Change from 6 months Self-assessment of fatigue at 9 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome	6 months to 9 months
Difference in Self-assessment of fatigue at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome	3 months
Difference in Self-assessment of fatigue at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome	6 months
Change from baseline Self-assessment of pain at 3 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	baseline to 3 months
Change from baseline Self-assessment of pain at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	baseline to 6 months
Change from 3 months Self-assessment of pain at 6 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	3 months to 6 months
Change from 6 months Self-assessment of pain at 9 months	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	6 months to 9 months
Difference in Self-assessment of pain at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	3 months
Difference in Self-assessment of pain at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome	6 months
Change from baseline physical condition assessment in 30 second sit stand test at 3 months	Number of sits and stands during 30 seconds	baseline to 3 months
Change from baseline physical condition assessment in 30 second sit stand test at 6 months	Number of sits and stands during 30 seconds	baseline to 6 months
Change from 3 months physical condition assessment in 30 second sit stand test at 6 months	Number of sits and stands during 30 seconds	3 months to 6 months
Change from 6 months physical condition assessment in 30 second sit stand test at 9 months	Number of sits and stands during 30 seconds	6 months to 9 months
Difference in physical condition assessment in 30 second sit stand test at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Number of sits and stands during 30 seconds	3 months
Difference in physical condition assessment in 30 second sit stand test at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Number of sits and stands during 30 seconds	6 months
Change from baseline physical condition assessment in 30 second dumbell lift tests at 3 months	Number lifts during 30 seconds	baseline to 3 months
Change from baseline physical condition assessment in 30 second dumbell lift tests at 6 months	Number lifts during 30 seconds	baseline to 6 months
Change from 3 months physical condition assessment in 30 second dumbell lift tests at 6 months	Number lifts during 30 seconds	3 months to 6 months
Change from 6 months physical condition assessment in 30 second dumbell lift tests at 9 months	Number lifts during 30 seconds	6 months to 9 months
Difference in physical condition assessment in 30 second dumbell lift tests at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Number lifts during 30 seconds	3 months
Difference in physical condition assessment in 30 second dumbell lift tests at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Number lifts during 30 seconds	6 months
Change from baseline physical condition assessment in 30 meters walk at 3 months	Time untill completion	baseline to 3 months
Change from baseline physical condition assessment in 30 meters walk at 6 months	Time untill completion	baseline to 6 months
Change from 3 months physical condition assessment in 30 meters walk at 6 months	Time untill completion	3 months to 6 months
Change from 6 months physical condition assessment in 30 meters walk at 9 months	Time untill completion	6 months to 9 months
Difference in physical condition assessment in 30 meters walk at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Time untill completion	3 months
Difference in physical condition assessment in 30 meters walk at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Time untill completion	6 months
Change from baseline Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 3 months	Structured self-report questionnaire	baseline to 3 months
Change from baseline Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months	Structured self-report questionnaire	baseline to 6 months
Change from 3 months Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months	Structured self-report questionnaire	3 months to 6 months
Change from 6 months Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 9 months	Structured self-report questionnaire	6 months to 9 months
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	Structured self-report questionnaire	3 months
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	Structured self-report questionnaire	6 months
Change in baseline Beck's Anxienty Inventory at 3 months	Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome	baseline to 3 months
Change in baseline Beck's Anxienty Inventory at 6 months	Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome	baseline to 6 months
Change in 3 months Beck's Anxienty Inventory at 6 months	Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome	3 months to 6 months
Change in 6 months Beck's Anxienty Inventory at 9 months	Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome	6 months to 9 months
Difference in Beck's Anxienty Inventory at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome	3 months
Difference in Beck's Anxienty Inventory (BAI) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome	6 months
Change in baseline Beck's Depression Inventory - II (BDI-II) at 3 months	BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome	baseline to 3 months
Change in baseline Beck's Depression Inventory - II (BDI-II) at 6 months	BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome	baseline to 6 months
Change in 3 months Beck's Depression Inventory - II (BDI-II) at 6 months	BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome	3 months to 6 months
Change in 6 months Beck's Depression Inventory - II (BDI-II) at 9 months	BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome	6 months to 9 months
Difference in Beck's Depression Inventory - II (BDI-II) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome	3 months
Difference in Beck's Depression Inventory - II (BDI-II) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group	BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome	6 months

Collaborators and Investigators

• Sponsor: National Institute of Mental Health, Czech Republic
• Collaborators: University Hospital Vinohrady; C2P s.r.o.; Ministry of Industry and Trade, Czech Republic

Publications and helpful links

Helpful Links

• National Institute of Mental Health - official website

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): March 2, 2022
• Study Completion (Actual): March 2, 2022

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Microbiome; Probiotics; Cognitive Health; Gut Microflora
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Memory Disorders
• Other Study ID Numbers: FV-40032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No