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 range

55 Years – 80 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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