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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05051501
Acronym
CleverAgeBiota
Enrollment
90
Registered
2021-09-21
Start date
2021-01-06
Completion date
2022-03-02
Last updated
2023-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Aging Problems, Cognitive Decline, Gut Health, Memory Deficits, Mood Change

Keywords

Probiotics, Microbiome, Gut Microflora, Cognitive Health

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.

Interventions

DIETARY_SUPPLEMENTProbiotics 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.

Sponsors

C2P s.r.o.
CollaboratorUNKNOWN
University Hospital Vinohrady
CollaboratorUNKNOWN
Ministry of Industry and Trade, Czech Republic
CollaboratorUNKNOWN
National Institute of Mental Health, Czech Republic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Participants with an odd identification number will receive substance A in the first three months and a complementary substance B in the following three months. Participants with an even identification number will receive substance B in the first three months and a complementary substance A in the following three months. Manufacturer of the new probiotics C2P will mark one set of substances as set A and a complementary set of substances as set B. If substance A/B is a probiotic or placebo will be known to a manufacturer only. Investigators and participants are blinded to this information.

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

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 monthsbaseline to 3 monthsALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 monthsbaseline to 6 monthsALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
Change from 3 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months3 months to 6 monthsALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
Change from 6 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 9 months6 months to 9 monthsALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
Change from 3 months cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months3 months to 6 monthsRAVLT 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
Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome
Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 3 monthsbaseline to 3 monthsABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome
Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 6 monthsbaseline to 6 monthsABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome
Change from 3 months cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months3 months to 6 monthsABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome
Change from 6 months cognitive function in the Assessment Battery of Cognition (ABACO) at 9 months6 months to 9 monthsABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome
Difference in cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome
Difference in cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome
Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 3 monthsbaseline to 3 monthsSemantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 6 monthsbaseline to 6 monthsSemantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
Change from 3 months cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months3 months to 6 monthsSemantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
Change from 6 months cognitive function in Semantic word recollection (category: animals, 1 min) at 9 months6 months to 9 monthsSemantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
Difference in cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsSemantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
Difference in cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsSemantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome
Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 monthsbaseline to 3 monthsRAVLT 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
Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 monthsbaseline to 6 monthsRAVLT 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
Change from 6 months cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 9 months6 months to 9 monthsRAVLT 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
Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsRAVLT 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
Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsRAVLT 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
Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - Symbols subtest at 3 monthsbaseline to 3 monthsThe 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
Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - Symbols subtest at 6 monthsbaseline to 6 monthsThe 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
Change in 3 month cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - Symbols subtest at 6 months3 months to 6 monthsThe 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
Change in 6 month cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - Symbols subtest at 9 months6 months to 9 monthsThe 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
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 group3 monthsThe 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
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 group6 monthsThe 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
Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 3 monthsbaseline to 3 monthsThe TMT is a validated measure of cognitive function, the time upon completion is measured
Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 6 monthsbaseline to 6 monthsThe TMT is a validated measure of cognitive function, the time upon completion is measured
Change in 3 month cognitive function in Trail Making Test (TMT), Parts A & B at 6 months3 months to 6 monthsThe TMT is a validated measure of cognitive function, the time upon completion is measured
Change in 6 month cognitive function in Trail Making Test (TMT), Parts A & B at 9 months6 months to 9 monthsThe TMT is a validated measure of cognitive function, the time upon completion is measured
Difference cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsThe TMT is a validated measure of cognitive function, the time upon completion is measured
Difference cognitive function in Trail Making Test (TMT), Parts A & B at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsThe TMT is a validated measure of cognitive function, the time upon completion is measured
Change in baseline mood in Geriatric Depression Scale at 3 months.baseline to 3 monthsA self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome
Change in baseline mood in Geriatric Depression Scale at 6 months.baseline to 6 monthsA self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome
Change in 3 month mood in Geriatric Depression Scale at 6 months.3 months to 6 monthsA self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome
Change in 6 month mood in Geriatric Depression Scale at 9 months.6 months to 9 monthsA self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome
Difference in mood in Geriatric Depression Scale at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsA self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome
Difference in mood in Geriatric Depression Scale at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsA self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome
Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 monthsbaseline to 3 monthsFAQ-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
Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 monthsbaseline to 6 monthsFAQ-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
Change from 3 month self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months3 months to 6 monthsFAQ-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
Change from 6 month self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 9 months6 months to 9 monthsFAQ-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
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 group3 monthsFAQ-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
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 group6 monthsFAQ-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
Changes in tau proteinbaseline to 3 monthsMeasured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Changes in neurofilament light levelsbaseline to 3 monthsMeasured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Changes in immunocomplex antibody levelsbaseline to 3 monthsMeasured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels
Biochemical parameters in bloodbaseline to 3 monthsChange from baseline Blood metabolome assessed using mass spectrometry at 3 months
Biochemical parameters in urinebaseline to 3 months15ml 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
Biochemical parameters in stoolbaseline to 3 monthsChange from baseline Stool metabolome assessed using mass spectrometry at 3 months

Secondary

MeasureTime frameDescription
Change from baseline physical condition assessment in 30 second dumbell lift tests at 3 monthsbaseline to 3 monthsNumber lifts during 30 seconds
Change from baseline physical condition assessment in 30 second dumbell lift tests at 6 monthsbaseline to 6 monthsNumber lifts during 30 seconds
Change from 3 months physical condition assessment in 30 second dumbell lift tests at 6 months3 months to 6 monthsNumber lifts during 30 seconds
Change from 6 months physical condition assessment in 30 second dumbell lift tests at 9 months6 months to 9 monthsNumber lifts during 30 seconds
Difference in physical condition assessment in 30 second dumbell lift tests at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsNumber lifts during 30 seconds
Difference in physical condition assessment in 30 second dumbell lift tests at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsNumber lifts during 30 seconds
Change from baseline physical condition assessment in 30 meters walk at 3 monthsbaseline to 3 monthsTime untill completion
Change from baseline physical condition assessment in 30 meters walk at 6 monthsbaseline to 6 monthsTime untill completion
Change from 3 months physical condition assessment in 30 meters walk at 6 months3 months to 6 monthsTime untill completion
Change from 6 months physical condition assessment in 30 meters walk at 9 months6 months to 9 monthsTime untill completion
Difference in physical condition assessment in 30 meters walk at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsTime untill completion
Difference in physical condition assessment in 30 meters walk at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsTime untill completion
Change from baseline Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 3 monthsbaseline to 3 monthsStructured self-report questionnaire
Change from baseline Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 monthsbaseline to 6 monthsStructured self-report questionnaire
Change from 3 months Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months3 months to 6 monthsStructured self-report questionnaire
Change from baseline Questionnaire of adverse events (abbreviation in original language: DNU) at 3 monthsbaseline to 3 monthsDNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events
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 group3 monthsStructured self-report questionnaire
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 group6 monthsStructured self-report questionnaire
Change in baseline Beck's Anxienty Inventory at 3 monthsbaseline to 3 monthsBeck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome
Change in baseline Beck's Anxienty Inventory at 6 monthsbaseline to 6 monthsBeck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome
Change in 3 months Beck's Anxienty Inventory at 6 months3 months to 6 monthsBeck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome
Change in 6 months Beck's Anxienty Inventory at 9 months6 months to 9 monthsBeck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome
Difference in Beck's Anxienty Inventory at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsBeck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome
Difference in Beck's Anxienty Inventory (BAI) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsBeck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome
Change in baseline Beck's Depression Inventory - II (BDI-II) at 3 monthsbaseline to 3 monthsBDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome
Change in baseline Beck's Depression Inventory - II (BDI-II) at 6 monthsbaseline to 6 monthsBDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome
Change in 3 months Beck's Depression Inventory - II (BDI-II) at 6 months3 months to 6 monthsBDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome
Change in 6 months Beck's Depression Inventory - II (BDI-II) at 9 months6 months to 9 monthsBDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome
Difference in Beck's Depression Inventory - II (BDI-II) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsBDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome
Difference in Beck's Depression Inventory - II (BDI-II) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsBDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome
Change from 6 months Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 9 months6 months to 9 monthsStructured self-report questionnaire
Change from baseline Questionnaire of adverse events (abbreviation in original language: DNU) at 6 monthsbaseline to 6 monthsDNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events
Change from 3 months Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months3 months to 6 monthsDNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events
Change from 6 months Questionnaire of adverse events (abbreviation in original language: DNU) at 9 months6 months to 9 monthsDNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events
Difference in the Questionnaire of adverse events (abbreviation in original language: DNU) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsDNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events
Difference in the Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsDNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events
Change from baseline Self-assessment of memory at 3 monthsbaseline to 3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from baseline Self-assessment of memory at 6 monthsbaseline to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from 3 months Self-assessment of memory at 6 months3 months to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from 6 months Self-assessment of memory at 9 months6 months to 9 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Difference in Self-assessment of memory at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Difference in Self-assessment of memory at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from baseline Self-assessment of digestion at 3 monthsbaseline to 3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from baseline Self-assessment of digestion at 6 monthsbaseline to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from 3 months Self-assessment of digestion at 6 months3 months to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from 6 months Self-assessment of digestion at 9 months6 months to 9 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Difference in Self-assessment of digestion at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Difference in Self-assessment of digestion at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from baseline Self-assessment of overall health at 3 monthsbaseline to 3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from baseline Self-assessment of overall health at 6 monthsbaseline to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from 3 months Self-assessment of overall health at 6 months3 months to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from 6 months Self-assessment of overall health at 9 months6 months to 9 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Difference in Self-assessment of overall health at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Difference in Self-assessment of overall health at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from baseline Self-assessment of sleep quality at 3 monthsbaseline to 3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from baseline Self-assessment of sleep quality at 6 monthsbaseline to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from 3 months Self-assessment of sleep quality at 6 months3 months to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from 6 months Self-assessment of sleep quality at 9 months6 months to 9 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Difference in Self-assessment of sleep quality at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Difference in Self-assessment of sleep quality at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from baseline Self-assessment of anxiety at 3 monthsbaseline to 3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Change from baseline Self-assessment of anxiety at 6 monthsbaseline to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Change from 3 months Self-assessment of anxiety at 6 months3 months to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Change from 6 months Self-assessment of anxiety at 9 months6 months to 9 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Difference in Self-assessment of anxiety at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Difference in Self-assessment of anxiety at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Change from baseline Self-assessment of fatigue at 3 monthsbaseline to 3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Change from baseline Self-assessment of fatigue at 6 monthsbaseline to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Change from 3 months Self-assessment of fatigue at 6 months3 months to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Change from 6 months Self-assessment of fatigue at 9 months6 months to 9 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Difference in Self-assessment of fatigue at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Difference in Self-assessment of fatigue at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome
Change from baseline Self-assessment of pain at 3 monthsbaseline to 3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from baseline Self-assessment of pain at 6 monthsbaseline to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from 3 months Self-assessment of pain at 6 months3 months to 6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from 6 months Self-assessment of pain at 9 months6 months to 9 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Difference in Self-assessment of pain at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Difference in Self-assessment of pain at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsSelf-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome
Change from baseline physical condition assessment in 30 second sit stand test at 3 monthsbaseline to 3 monthsNumber of sits and stands during 30 seconds
Change from baseline physical condition assessment in 30 second sit stand test at 6 monthsbaseline to 6 monthsNumber of sits and stands during 30 seconds
Change from 3 months physical condition assessment in 30 second sit stand test at 6 months3 months to 6 monthsNumber of sits and stands during 30 seconds
Change from 6 months physical condition assessment in 30 second sit stand test at 9 months6 months to 9 monthsNumber of sits and stands during 30 seconds
Difference in physical condition assessment in 30 second sit stand test at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group3 monthsNumber of sits and stands during 30 seconds
Difference in physical condition assessment in 30 second sit stand test at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group6 monthsNumber of sits and stands during 30 seconds

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026