CompletedPhase 2

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

Czechia90 participantsStarted 2021-01-06

Plain-language 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.

Who can participate

Age range55 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 radiotherap…

What they're measuring

Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months

Timeframe: baseline to 3 months

Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months

Timeframe: baseline to 6 months

Change from 3 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months

Timeframe: 3 months to 6 months

Change from 6 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 9 months

Timeframe: 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

Timeframe: 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

Timeframe: 6 months

Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months

Timeframe: baseline to 3 months

Trial details

NCT IDNCT05051501

SponsorNational Institute of Mental Health, Czech Republic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-02

View on ClinicalTrials.gov More Memory Deficits trials

Plain-language summary

Who can participate

Age range55 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months

Timeframe: baseline to 3 months

Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months

Timeframe: baseline to 6 months

Change from 3 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months

Timeframe: 3 months to 6 months

Change from 6 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 9 months

Timeframe: 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

Timeframe: 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

Timeframe: 6 months

Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months

Timeframe: baseline to 3 months