Brain-Gut Axis
Conditions
Interventions
This is a three-arm, triple-blind, placebo-controlled randomized clinical study. 60 individuals will be selected for the Alzheimer&apos
s disease (AD) group, 60 individuals for the mild cognitive impairment (MCI) group and 120 individuals for the control group, aged 60 years or over. The control group will have a greater number of ind
Group 2) Individuals with AD
3) Individuals with MCI. The intervention under study will be a blend of probiotics (Lactobacillus casei, Lactobacillus acidophilus, Bifidobacterium bifidum and Bifidobacterium breve 1×109 CFU/mL), or
Sponsors
Universidade do Extremo Sul Catarinense
Universidade do Extremo Sul Catarinense
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Individuals of both sexes, who use the SUS, residents of municipalities in the South of Brazil; individuals who agree to participate in the study and sign the Informed Consent Form (TCLE); age equal to or greater than 60 years; oral route of feeding; cognitive level that allows questionnaires to be carried out; residents in the municipality of Criciúma and treated at the Centro and Rio Maina Basic Health Units or also at the UNESC geriatrics outpatient clinic; residents in long-term care institutions in municipalities in the South of Brazil
Exclusion criteria
Exclusion criteria: Partial (40 to 60% impairment) or total visual impairment; severe hearing impairment (cannot hear sounds below 80 decibels, on average) and deep (when you do not hear sounds emitted with an intensity lower than 91 decibels); diagnosis of general psychiatric disorders; not being able to answer the questionnaires independently; having diseases in the gastrointestinal tract, mainly diseases related to the intestine; neurological diagnosis compatible with syndromes or malformations; other neurological events that may cause changes in swallowing; being using antibiotics; recent viral infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: An improvement in participants’ cognitive function after the intervention was expected, assessed using the MMSE, Clock Drawing Test, and Verbal Fluency Test, based on the comparison of numerical scores between pre- and post-intervention periods. Results were to be expressed as mean and standard deviation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: It was expected that the sociodemographic and health-related characteristics of participants, assessed through a structured questionnaire developed by the researchers, would be similar between the probiotic and placebo groups, as well as among the control, mild cognitive impairment (MCI), and Alzheimer’s disease (AD) subgroups. Data were presented as frequency and percentage or mean and standard deviation.;Expected outcome 3: A reduction in depressive symptoms after the intervention was expected, assessed using the Geriatric Depression Scale (GDS-15), based on comparisons between pre- and post-intervention scores.;Expected outcome 4: A reduction in anxiety symptoms after the intervention was expected, assessed using the Generalized Anxiety Disorder Scale (GAD-7), based on comparisons between pre- and post-intervention scores.;Expected outcome 5: An improvement or maintenance of swallowing function after the intervention was expected, assessed through a clinical evaluation performed by a speech-language pathologist.;Expected outcome 6: An improvement or maintenance of nutritional status after the intervention was expected, assessed using the Mini Nutritional Assessment (MNA), based on comparisons between pre- and post-intervention scores.;Expected outcome 7: Favorable changes in biochemical markers after the intervention were expected, measured using standardized laboratory methods, based on comparisons between pre- and post-intervention periods.;Expected outcome 8: Modulation of bowel habit patterns after the intervention was expected, assessed using the Bristol Stool Form Scale, as well as changes in gut microbiota composition analyzed by 16S rRNA gene sequencing, based on comparisons between pre- and post-intervention periods and between the probiotic and placebo groups.;Expected outcome 9: A reduction in DNA damage after the intervention was expected, assessed using the comet assay and quantified by the tail intensity (%) parameter, based on c | — |
Countries
Brazil
Contacts
Public ContactJosiane Budni
Universidade do Extremo Sul Catarinense
Outcome results
None listed