The Effects of Microbiological Spectrum Changes to Improve Cognitive Health in Aging Population
Condition: Memory Deficits; Mood Change; Gut Health; Aging Problems; Aging; Cognitive Decline
MeSH terms: Memory Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Probiotics C2P
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Probiotics; Microbiome; Gut Microflora; Cognitive Health